MEDICAL DEVICES RULES, 2017
Published vide Notification No. G.S.R. 78(E), dated 31st January, 2017
G.S.R. 78(E).-Whereasthe draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and Sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government, after consultation with the Drugs Technical Advisory Board, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Gazette containing the said notification were made available to the public;
And Whereas, copies of the Gazette containing the said notification were made avail
(1) These rules may be called the Medical Devices Rules, 2017.
(2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018.
These rules shall be applicable in respect of,-
(i) substances used forin vitrodiagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940)
In these rules, unless the context otherwise requires,-
(a)"academic clinical study"means a clinical study conducted for academic purpose on a medical device for the approved or a new intended use, new material of construction, new improved design or new population;
(b)"Act"means the Drugs and Cosmetics Act, 1940 (23 of 1940);
(c)"active diagnostic medical device"means any active medical device used, whether alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity;
(d)"active medical device"means a medical device, the operation of which depends on a source of electrical ene
(1) Medical devices other thanin vitrodiagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:-
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
(2)In vitrodiagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:-
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
Any person who intends to apply for grant of licence in respect of medical devices for,-
(i) import;
(ii) manufacture for sale or for distribution; and
(iii) sale, stock, exhibit or offer for sale,
may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices andin vitrodiagnostic medical devices.
Medical device manufacturer shall follow the essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the contemporary scientific and technological knowledge and development:
Provided that the guidelines to be so specified shall be in conformity with the provisions of the Act and these rules.
(1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
(2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.
(3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer's standards.
(1) The Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to,-
(i) import of all Classes of medical devices;
(ii) manufacture of Class C and Class D medical devices;
(iii) clinical investigation and approval of investigational medical devices;
(iv) clinical performance evaluation and approval of newin vitrodiagnostic medical devices and;
(v) co-ordination with the State Licensing Authorities.
(2) The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to,-
(1) The Central Licensing Authority, may with the prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organization not below the rank of Assistant Drugs Controller.
(2) The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central Licensing Authority under its name and seal.
(3) The State Licensing Authority, may, with the prior approval of the State Government, by an order in writing, delegate all or any of its powers to any officer under its control.
(4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of the State Licensing Authority under its name and seal.
Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall be the controlling officer to supervise and give instructions to any officer subordinate to such controlling officer to exercise powers and functions under these rules for areas and purposes specified, by an order, of the Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State concerned.
The Central Government may, by notification, designate such institute, firm or a Government aided or Government organization, which fulfills the criteria specified from time to time by the Government, as the National Accreditation Body:
Provided that the National Accreditation Board for Certification Bodies under the Quality Council of India, registered under the Societies Registration Act, 1860 (21 of 1860) set up by the Ministry of Commerce and Industry in the Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies referred to in rule 13, till such time any other body for the purpose is notified, with immediate effect.
(2) The National Accreditation Body shall have the required number of competent persons for proper performance of its functions
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The National Accreditation Body shall,-
(a) lay down the conformity assessment activities for accreditation of Notified Bodies and lay down standards for such accreditation;
(b) prepare norms and procedures for accreditation of Notified Body;
(c) audit a Notified Body periodically for assessing conformance with these rules and the norms laid down by it.
(1) Any institute, organization or body corporate may seek accreditation, after notification of these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner as may be determined by the National Accreditation Body from time to time.
(2) The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority.
(3) Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A or Class B of medical devices in accordance with sub-rule (2),
A registered Notified Body, referred to in rule 13, shall carry out its duties and functions, in respect of Class A or Class B medical devices as specified in Part II of the Third Schedule.
A registered Notified Body shall carry out its duties and functions either by itself or by any other qualified person on its behalf as per specified procedure as detailed in Part II of the Third Schedule.
A registered Notified Body may charge fee from the applicant for the services rendered by it as may be determined by the Central Government.
(1) The Central Licensing Authority may, after giving an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons therefor, cancel the registration of a Notified Body or suspend it for such period as the Central Licensing Authority thinks fit, if in its opinion, the Notified Body has failed to comply with any provision of these rules.
(2) A registered Notified Body whose registration has been suspended or canceled under sub-rule (1) may, within thirty days of the receipt of a copy of the order by it, prefer an appeal to the Central Government and the Central Government may, after giving the Notified Body an opportunity of being heard, confirm, reverse or modify such order.
(3) The registration of a Notified Body with the Central Licensing Authority shall be deemed to have been canceled with effect from the expiry of the d
(1) The Central Government may designate a Government Analyst appointed under section 20 of the Act as Medical Device Testing Officer.
(2) The Central Government or, as the case may be, the State Government, may designate an Inspector appointed under section 21 of the Act as Medical Device Officer.
(3) The Medical Device Testing Officer and Medical Device Officer designated under sub-rule (1) and sub-rule (2) respectively, while exercising powers and duties under the Act and these rules, shall be deemed to have been appointed as the Government Analyst and the Inspector, respectively.
(1) The Central Government may, by notification, establish Central medical devices testing laboratory for the purpose of,-
(a) testing and evaluation of medical devices; or
(b) functioning as an appellate laboratory; or
(c) to carry out any other function as may be specifically assigned to it.
(2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as central medical devices testing laboratory for the purposes specified in sub-rule (1):
Provided that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.
(1) Any person who intends to manufacture a Class A or Class B medical device includingin vitrodiagnostic medical device shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority.
(2) The application under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-3 for licence or in Form MD-4 for loan licence accompanied with a fee, as specified in the Second Schedule along with respective documents as specified in Part II of the Fourth Schedule.
(3) The application made under sub-rule (1), shall, amongst others, be accompanied with an undertaking to the effect that the requirements of Quality Management System as specified in the Fifth Schedule have been complied with.
(1) An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for licence or loan licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form MD-7 or Form MD-8, respectively.
(2) The application in Form MD-7 or Form MD-8 referred to in sub-rule (1) relating to Class C or Class D medical device, as the case may be, shall be accompanied with a fee as specified in the Second Schedule along with documents as specified in clause (ii) of Part II of the Fourth Schedule.
(3) The Central Licensing Authority may, wherever required, in case of Class C or Class D medical devices, use the services of any expert in the relevant field for scrutiny of application and other technical documents.
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While making application for grant of licence or loan licence under rule 20 or rule 21, the applicant shall meet the following requirements, namely:-
(i) the manufacturing site shall comply with the requirements of the Quality Management System as specified under the Fifth Schedule;
(ii) appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken and such staff shall possess the following educational qualification and experience,-
(a) degree in engineering in relevant branch or in pharmacy or in science in appropriate subject from a recognized University and shall have experience of not less than two years in manufacturing or testing of medical devices; or
(b) diploma in
(1) Before grant of licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site shall be inspected within a period of sixty days from the date of application by a team comprising not less than two Medical Device Officers which may include any officer senior to the Medical Device Officer with or without an expert, or a Notified Body referred to in sub-rule (4) of rule 13:
Provided that no inspection of a medical device manufacturing site for grant of loan licence to manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to manufacture such medical device for sale or for distribution.
(2) The composition of the inspection team referred to in sub-rule (1) shall be determined by the controlling officer and no inspection shall be carried out without prior approval of t
After completion of inspection as referred to in rule 23, the inspection team shall forward a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central Licensing Authority, through online portal of the Ministry of Health and Family Welfare in the Central Government and forward a copy of the same to the applicant.
(1) If the Central Licensing Authority, after receipt of the report as referred to in rule 24, and such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of these rules have been complied, that Authority shall grant a licence in Form MD-9, or loan licence in Form MD-10 or may reject the application for reasons to be recorded in writing, within a period of forty five days from the date the inspection report has been received.
(2) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected under sub-rule (1), the aggrieved person may file an appeal before the Central Government within forty five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of sixty days.
After grant of licence or loan licence in Form MD-5, Form MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following conditions, namely:-
(i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or State Licensing Authority, as the case may be;
(ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall within fifteen days of such event coming to the notice of licence holder;
(iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State Licensing Au
In case of change in constitution of a licencee, after grant of licence under sub-rule (4) of rule 20 or sub-rule (6) of rule 20 or sub-rule (1) of rule 25, as the case may be, the manufacturer inform the Central Licensing Authority or the State Licensing Authority, as the case may be, within forty five days and shall shall make an application under sub-rule (1) of rule 20 or sub-rule (1) of rule 21, as the case may be, for grant of licence within a period of one hundred eighty days from the date of such change in constitution:
Provided that the existing licence shall be deemed to be valid till such time, a fresh licence is issued or application is rejected by the State Licensing Authority or the Central Licensing Authority, as the case may be:
Provided further that if the application is rejected, the manufacturer may appeal to the Central Government or the State Government, as
The State Licensing Authority shall, in cases where licence has been granted for manufacturing Class A and Class B medical devices under rule 20, cause an inspection of the manufacturing site to be carried out by a Medical Device Officer on a random basis and such inspection shall not be less than two per cent. of the total audits carried out by Notified Bodies within that State for that class of medical device.
(1) A licence or loan licence issued in Form MD-5, Form MD-6, Form MD-9 or Form MD- 10 shall remain valid in perpetuity, subject to payment of licence retention fee as specified in the Second Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or canceled by State Licensing Authority or the Central Licensing Authority, as the case may be.
(2) If the licence holder fails to pay the required licence retention fee on or before due date as referred to in sub-rule (1), the licence holder shall, in addition to the licence retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the licence retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the licence shall be deemed to have been canceled.
(1) Where the licencee contravenes any provision of the Act and these rules, the State Licensing Authority or the Central Licensing Authority, as the case may be, shall, after giving the licencee an opportunity to show cause as to why such an order should not be passed, shall by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or cancel the licence or loan licence.
(2) A licencee whose licence or loan licence has been suspended or canceled by the State Licensing Authority or the Central Licensing Authority, as the case may be, under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government or the Central Government, as the case may be, and the State Government or the Central Government, shal
(1) Small quantity of Class A or Class B or Class C or Class D of medical devices may be manufactured for the purpose of clinical investigations, test, evaluation, examination, demonstration or training for which an application shall be made in Form MD-12 to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule.
(2) The application made under sub-rule (1) shall also be accompanied with the following documents, namely:-
(a) brief description of the medical device including intended use, material of construction, design and an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such medical devices;
(b) list of equipment, instruments;
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A licence in Form MD-13 under rule 31 shall be subject to the following conditions, namely:-
(a) the licencee shall use the medical device manufactured under licence granted under sub-rule (3) of rule 31 exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or training at the place specified in the licence;
(b) the licencee shall allow any Medical Device Officer to enter, with or without notice, the premises where the medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation, examination, demonstration or training is being conducted on such device;
(c) the licencee shall maintain a record of the quantity of medical device manufactured, tested and stocked and its disposition.
(1) Where any licencee under rule 31 contravenes any provision of these rules, the Central Licensing Authority, shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
(2) The Central Licensing Authority shall, after giving an opportunity to the licencee to explain in writing licencee's defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
(3) A licencee, whose licence has been canceled, may appeal to the Central Government within forty five days from the date of the order.
An authorized agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.
(2) The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with respective documents as specified in the Fourth Schedule:
Provided that any change in the documents submitted at the time of application and prior to grant of licence shall be informed, in writing, to the Central Licensing Authority.
(3) Where the Central Licensing Authority, has reason to
(1) On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose.
(2) The applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure required in connection with the visit to the overseas manufacturing site under sub-rule (1).
(1) After examination of documents furnished with the application under sub-rule (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such application for which reasons shall be recorded in writing, within a period of nine months from the date of application.
(2) In the event of rejection, the applicant may appeal to the Central Government within a period of forty five days and that Government, may, after such enquiry into the matter, as considered necessary, pass orders in relation thereto within a period of ninety days from the date of appeal.
(3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authorit
A licence granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless, it has been canceled or surrendered, provided the authorized agent deposits the licence retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each licenced medical device after completion of every five years from the date of its issue:
Provided that the Central Licensing Authority may permit to deposit the licence retention fee after due date but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem:
Provided further that if the licencee fails to deposit the licence retention fee within the above stipulated period, the licence shall be deemed to have been canceled.
(1) The licencee shall comply with the following conditions, namely:-
(i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or the State Licensing Authority, as the case may be;
(ii) the licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen days of any administrative action taken on account of any adverse reaction, such as market withdrawal, regulatory restrictions, cancellation of authorization or declaration of the medical device as not of standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the medical device is marketed, sold or distributed;
(iii) authorized agen
Section R.38 of the Medical Devices Rules, 2017, primarily deals with the exemption provisions, compliance, and regulatory oversight concerning specific categories of medical devices, particularly focusing on the standards, testing, and certification requirements for manufacturers and importers. It aims to streamline the registration process, ensure safety, and prevent misuse or misrepresentation of medical devices in India.
Section R.38 provides for exemptions from certain provisions of the Rules for specific medical devices listed in Schedule VIII, especially those that are custom-made or imported under certain conditions. It also stipulates that such devices must meet prescribed standards, and any breach or misrepresentation can lead to penalties, including suspension or debarment. The section emphasizes the authority of the Central Government and the licensing authority to amend, modify, or revoke exemptions as deemed necessary for public health and safety.
This section covers:- Devices that are exempted from certain rules under Schedule VIII, including custom-made devices.- The process for testing, certification, and compliance with standards.- The authority to revoke exemptions or impose penalties.- The regulatory framework for ensuring safety and efficacy of medical devices in India.- The mechanism for updating or amending the schedule and rules to reflect new standards or technological advances.
Violations of the provisions, including submitting false documents, manufacturing or importing non-compliant devices, or misusing exemptions, can attract:- Penalties such as fines.- Imprisonment for specified durations (up to 5 years or more in severe cases).- Forfeiture of devices.- Suspension or cancellation of licenses.- Debarment from manufacturing or importing activities.
In conclusion, Section R.38 of the Medical Devices Rules, 2017, forms a crucial part of the regulatory architecture, balancing facilitation of device availability with stringent safety and compliance measures, backed by clear penalties for violations and a mechanism for periodic updates as per technological progress.
In case of change in constitution of a licencee, after grant of licence under sub-rule (1) of rule 36, an application shall be made under sub-rule (1) of rule 34 for grant of licence within a period of one hundred and eighty days from the date of such change in constitution:
Provided that the existing licence shall be deemed to be valid till such time, the fresh licence is issued or application is rejected by the Central Licensing Authority.
Explanation.- For the purpose of this rule, the licencee shall include overseas manufacturer who executed the power of attorney in favour of authorized agent.
(1) Notwithstanding anything contained in these rules, any medical device orin vitrodiagnostic medical device may be imported for the purpose of clinical investigations or test or evaluation or demonstration or training.
(2) The person who desires to import medical device under sub-rule (1), shall apply for an import licence for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16, accompanied by such fee as specified in the Second Schedule.
(3) On receipt of the application under sub-rule (2), the Central Licensing Authority shall determine, the quantity of the medical devices, after taking into account the requirement for clinical investigation, approved clinical investigation plan, and information and documents submitted by the applicant.
(1) If the Central Licensing Authority, after such enquiry, if any, is satisfied that the requirements of these rules have been complied, the said authority shall grant a test licence in Form MD-17, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application under sub-rule (2) of rule 40.
(2) The medical device for which a test licence has been granted under sub-rule (1), shall be used exclusively for purposes of clinical investigation, test, evaluation, demonstration or training, as the case may be, and such clinical investigations or test or evaluation or training, shall be conducted at a place specified in such test licence:
Provided that in cases where the medical device is required to be taken to any place other than the ones mentioned in the test licence, the Cen
(1) Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD-18 and such application shall be accompanied by documents required and the fee as specified in the Second Schedule.
(2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant import licence for treatment of patient in Form MD-19.
(1) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions, namely,-
(i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of such passenger;
(ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so direct;
(iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered medical practitioner;
(iv) the medical device has been prescribed by a registered medical practitioner; and
(v) the medical device so imported shal
The following particulars shall be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed, namely,-
(a) name of the medical device;
(b) the details necessary for the user to identify the device and its use;
(c) the name of manufacturer and address of manufacturing premises where the device has been manufactured;
(d) the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package expressed in metric system;
(e) the month and year of manufacture and expiry (alternatel
The labels on packages or container of devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack or shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed:-
(a) name of the device;
(b) the distinctive batch number or lot number or serial number preceded by the word "Lot No." or "Lot" or "Batch No." or "B. No." or "Serial No.";
(c) date of expiry, if any;
(d) the name and address of manufacturer and address of actual premises where the device has been manufactured;
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With effect from 1st day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier.
Explanation.—For the purposes of this rule,-
(i) "device identifier" means a global trade item number;.
(ii) "production identifier" means a serial number, lot or batch number, software as a medical device version, manufacturing and or expiration date.
The shelf life of the medical devices, shall be determined keeping in view the technical parameters and shall ordinarily not exceed sixty months from the date of manufacture to be reckoned from month to month (i.e. January to January), except in cases where satisfactory evidence is produced by the manufacturer to justify a shelf life of more than sixty months of a device to the satisfaction of the Central Licensing Authority:
Provided that any medical device, whose total shelf life claim is less than ninety days, shall not be allowed to be imported by the licensing authority if it has less than forty per cent. residual shelf-life on the date of import:
Provided further that any medical device, whose total shelf life claim is between ninety days and one year, shall not be allowed to be imported by the licensing authority if it has less th
Any medical device or newin vitrodiagnostic medical device imported or manufactured, for the purpose of clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.
No person or sponsor shall conduct any clinical investigation in respect of investigational medical device in human participants except in accordance with these rules and in accordance with the permission granted by the Central Licensing Authority.
(1) The Ethics Committee constituted under rule 122DD of the Drugs and Cosmetics Rules, 1945 shall perform the functions and duties under these rules and shall be deemed to be constituted under these rules.
(2) The provisions of Ethics Committee provided in rule 122DD of the Drugs and Cosmetics Rules, 1945 shall, except where specifically provided under these rules, be applicablemutatis mutandis, for the purpose of clinical investigation and clinical performance evaluation under this Chapter.
(1) An application for grant of permission to conduct clinical investigation for investigational medical device shall be made to the Central Licensing Authority in Form MD-22 by a sponsor and shall be accompanied with information specified in the Seventh Schedule.
(2) An application for grant of permission to conduct,-
(a) a pilot clinical investigation on an investigational medical device as referred to in sub-rule (1) shall be accompanied with a fee as specified in the Second Schedule along with information as specified in the Seventh Schedule.
Explanation.—For the purposes of these rules, the pilot clinical investigation means clinical investigation to be carried out for the first time in human participants;
(b) a pivotal clinical investigation
The Central Licensing Authority, after such further enquiry, if any, as considered necessary, may,-
(i) if satisfied, that the requirements of these rules have been complied with, grant permission to conduct clinical investigation for an investigational medical device in Form MD-23;
(ii) if not satisfied with the requirements as referred to in sub-clause (i), reject the application, for reasons to be recorded in writing, within a period of ninety days, from the date of application made under sub-rule (1) of rule 51.
After grant of permission referred to in rule 52, the following conditions shall be complied with by the applicant, namely:-
(i) clinical investigation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee;
(ii) clinical investigation shall be conducted in accordance with the approved clinical investigation plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organization and provisions of the Seventh Schedule;
(iii) clinical investigation shall be registered with the Clinical Trial Registry of India before enrolling the first participant for such clinical investigation;
(iv) annual status report of each clinical investigation, as to whether it is ongoing, completed or te
(1) If any person to whom permission has been granted under rule 52 fails to comply with any of the conditions of permission or any of the provisions of the Act or these rules, the Central Licensing Authority may,-
(a) issue warning letter giving details of deficiency found; or
(b) debar the investigator or sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors to conduct any clinical investigation for such period as it thinks fit; or
(c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission.
(2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the receipt of such order before the Central Government, which may, after such enquiry
(1) Where any participant is injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall provide medical management to that participant.
(2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and such injury is attributable to the use of investigational medical device, the sponsor permitted under rule 52 shall provide to that participant, medical management and such compensation in the manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.
(3) Where death of a participant is related to clinical investigation and is attributable to the use of an investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetic
The Medical Devices Officer may enter any premises related to clinical investigation or clinical performance evaluation, with or without an expert, with prior approval of the Central Licensing Authority, with or without prior notice, to inspect the facilities, search and seize, record, data, documents, books, and medical devices including investigational medical devices or newin vitrodiagnostic medical device.
Every person, sponsor, clinical research organization, any other organization or investigator conducting a clinical investigation or his agent holding a permission under this Chapter shall maintain such data, record, registers and other documents for a period of seven years after completion of such investigation and shall furnish such information as may be required by the Central Licensing Authority or any other officer authorized by it in this behalf under rule 56.
Every person, sponsor, clinical research organization, any other organization or investigator conducting a clinical investigation or clinical performance evaluation or any agent authorized by any of them, as the case may be, shall, if so required, disclose to the Medical Device Officer or any other officer authorized by the Central Licensing Authority, the names, addresses and other particulars of persons involved in clinical investigation.
No person or sponsor shall conduct any clinical performance evaluation in respect of a newin vitrodiagnostic medical device on any specimen, including blood or tissue derived from human body except under, and in accordance with, the permission granted by the Central Licensing Authority subject to such conditions and in such form and manner as specified in these rules.
(2) An application for grant of permission to conduct, clinical performance evaluation of newin vitrodiagnostic medical device shall be made to the Central Licensing Authority in Form MD-24 by the sponsor and shall be accompanied with a fee as specified in the Second Schedule along with information specified in sub-rule (3) duly signed by the sponsor in India:
Provided that no fee shall be required to be paid by the institutes, organization, hospitals, run by the Central Go
After grant of permission referred to in sub-rule (5) of rule 59, the following conditions shall be complied with by the applicant,-
(i) clinical performance evaluation shall be conducted in accordance with the approved clinical performance evaluation plan and Good Clinical Practices Guidelines;
(ii) clinical performance evaluation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee;
(iii) clinical performance evaluation shall be registered with the Clinical Trial Registry of India before enrolling the first participant for such clinical performance evaluation;
(iv) annual status report of each clinical performance evaluation, as to whether it is ongoing, completed or terminated, shall be submitted to
(1) If any person to whom permission has been granted under sub-rule (5) of rule 59 fails to comply with any of the conditions of permission, the Central Licensing Authority may, suspend the permission for such period as it thinks fit or cancel either wholly or partly.
(2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days before the Central Government, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days.
Where any participant is injured on account of his participation in the clinical performance evaluation, the sponsor permitted under sub-rule (5) of rule 59 shall provide medical management to that participant.
(1) Save as otherwise provided in these rules, for import or manufacture of medical device which does not have predicate medical device, an application for grant of permission for such medical device after completion of its clinical investigation under Chapter VII shall be made to the Central Licensing Authority in Form MD-26 either by an authorized agent in case of import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule:
Provided that the medical device which does not have predicate medical device indicated in life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no therapy, the animal data
(1) An application for grant of permission to import or manufacture a newin vitrodiagnostic medical device may be made to the Central Licensing Authority in Form MD-28 either by an authorized agent in case of import or a manufacturer himself, as the case may be, and shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule:
Provided that the newin vitrodiagnostic medical device used for diagnosis of life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no diagnostic medical device available in the country, the clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Central Licensing Au
A Permission under rules 63 in Form MD-27 and rule 64 in Form MD-29 shall be subject to the following conditions, namely:-
(a) the medical device shall conform to the specifications submitted along with the application;
(b) the permission holder of Form MD-27 shall submit the Periodic Safety Update Report to the Central Licensing Authority from the date of launch in the market and such report shall be submitted every six months for first two years followed by submission of the said report annually for the two more successive years;
(c) the permission holder shall inform the date of launch of medical device in the market to the Central Licensing Authority;
(d) the permission holder of Form MD-27 shall submit the suspected unexpected serious adverse event within fifteen days of the awareness
The Medical Device Testing Officer shall cause the sample of medical device or portion thereof tested or evaluated as may be sent in a sealed package by the Medical Device Officer or any other person under the provisions of Chapters IV, V, VII and XI of these rules, and shall furnish the report of the result of the test or evaluation in accordance with these rules.
(1) The sample of medical device for test or evaluation under sub-section (4) of section 25 of the Act shall be sent by registered post in the outer cover addressed to the Director of central medical device testing laboratory in a sealed packet with a memorandum in Form MD-30.
(2) The packet as well as the outer cover shall be marked with a distinguishing number.
(3) A copy of the memorandum in Form MD-30 and a specimen impression of the seal used to seal the packet shall be separately sent by registered post to the Director of central medical device testing laboratory.
(4) After test or evaluation, the result of the test or evaluation shall be sent forthwith to the sender in Form MD-31.
(1) On receipt of the sealed package of medical device or portion thereof, from a Medical Device Officer or any other person for test or evaluation, the Medical Device Testing Officer shall compare the seals on the packet or on portion thereof with the specimen impression received separately and shall note the condition of the seals on the packet or on portion thereof.
(2) After completion of test or evaluation, the Medical Device Testing Officer shall forthwith furnish a report to the Medical Device Officer in triplicate in Form MD-32 of the result of the test or evaluation along with full protocols of the test or evaluation applied.
For the purpose of these rules, an application from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act shall be made in Form MD-33 and the report of such test or evaluation of the medical device which is prepared on such application shall be supplied to the applicant in Form MD-32.
Subject to the instructions of the Central Licensing Authority or State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to,-
(i) Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or State Licensing Authority, as the case may be, within the area assigned to him;
(ii) conform that the conditions of licence are being observed;
(iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and send them for test or evaluation:
Provided that in case of large sized medical device, wherein the o
Except for the purpose of official business or when required by a Court, a Medical Device Officer or Medical Device Testing Officer shall not, without the previous sanction, in writing, of his official superior, disclose to any person any information acquired while exercising such official duties.
An order in writing by a Medical Device Officer under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form MD-34.
No person in possession of a medical device in respect of which a Medical Device Officer has made an order under clause (c) of sub-section (1) of section 22 of the Act shall, in contravention of that order, sell or otherwise dispose of any stock of such medical device.
A receipt by a Medical Device Officer for the stock of any medical device or for any record, register, document or any other material object seized under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form MD-35.
The Medical Device Officer shall return the document, seized under section 22 of the Act, within a period of twenty days from the date of such seizure, to the person from whom they were recovered or produced, after copies thereof or extracts therefrom have been signed by the concerned Medical Device Officer and the person from whom they were recovered or produced.
When a Medical Device Officer takes a sample of a medical device other than medical device specified in proviso to clause (iii) of rule 70 for the purpose of test or evaluation, the Medical Device Officer shall inform such purpose in writing in Form MD-36 to the person from whom the sample has been taken and shall tender the fair price thereof under a written acknowledgment.
Where the fair price tendered under sub-section (1) of section 23 of the Act for sample of medical device or portion thereof taken for the purposes of test or evaluation has been refused by the person from whom such sample has been taken, the Medical Device Officer shall tender a receipt thereof to such person in Form MD-37.
(1) The sample of medical device or portion thereof sent by the Medical Device Officer to the Medical Device Testing Officer for test or evaluation under sub-section (4) of section 23 of the Act shall be sent by registered post or by courier or by hand in a sealed packet, enclosed with a memorandum in Form MD-38, in an outer cover addressed to the Medical Device Testing Officer.
(2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the Medical Device Testing Officer separately by registered post or handed over by hand and a copy of the memorandum shall be endorsed to the manufacturer.
(1) Where any person has been convicted for contravening any provisions of the Act or any these rules, the stock of medical device in respect of which the contravention has been made, shall be liable to confiscation.
(2) Where any person has been convicted for manufacturing any medical device which is misbranded, adulterated or spurious for sale, stocking or exhibiting for sale or distribution without a valid licence, any implements or machinery used in such manufacture, sale or distribution and any receptacle, package or covering in which such medical device is contained and the animals, vehicles, vessels or other conveyances used in carrying such medical device shall be liable to confiscation.
(1) The Court may refer the confiscated medical device to the Medical Device Officer concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the rules in any respect.
(2) If the Medical Device Officer, on the basis of Medical Device Testing Officer's report, finds the confiscated medical device to be not of standard quality or to contravene any of the provisions of the Act or rules made thereunder, the Medical Device Officer shall, with the approval of the Central Licensing Authority or State Licensing Authority, as the case may be, report to the Court accordingly and the Court shall thereupon order destruction of such medical devices, which shall take place under the supervision of the Medical Device Officer in the presence of such authority, if any, as may be directed by the Court:
Pro
(1) An application for grant of registration of a medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in Form MD-39 accompanied with a fee as specified in the Second Schedule along with the information specified in sub-rule (2).
(2) The application made under sub-rule (1) shall be accompanied with the following information, namely:-
(i) constitution of the medical device testing laboratory;
(ii) premises showing location and area of the different sections;
(iii) qualification, experience of technical staff employed for testing and the person in-charge of testing;
The following conditions shall be complied with by the applicant before grant of registration, namely,-
(i) the premises where the test or evaluation shall be carried out shall be well lighted and properly ventilated except where the nature of tests of any medical device warrants otherwise, and wherever necessary, the premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc;
(ii) the applicant shall provide adequate space having regard to the nature and number of samples of medical devices proposed to be tested and evaluated:
Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate;
(1) Before grant of registration to any medical device testing laboratory by the Central Licensing Authority, the premises shall be inspected by the Medical Device Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and suitability.
(2) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving findings on each aspect of inspection along with recommendations to the Central Licensing Authority with a copy to the applicant.
(3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the Central Licencing Authority may grant registration in Form MD-40 or if not satisfied, may, r
A registration granted under sub-rule (3) of rule 83 in Form MD-40, shall remain valid in perpetuity, unless, it is suspended or canceled, provided the registration holder deposits a registration retention fee to the Central Licensing Authority as specified in the Second Schedule after completion of every five years from the date of its issue:
Provided, that the Central Licensing Authority may permit to deposit the registration retention fee after due date but before the expiry of six months with a late fee at the rate of two per cent. per mensem or part thereof:
Provided further that, if the registration holder fails to deposit the registration retention fee within the above stipulated period, the registration shall be deemed to have been canceled for all purposes.
A registration granted under sub-rule (3) of rule 83 in Form MD-40, shall be subject to the following conditions, namely:-
(i) the registration certificate shall be kept on the approved premises and shall be produced at the request of the medical device officer;
(ii) the person holding registration certificate shall provide and maintain necessary qualified staff, adequate premises and equipment;
(iii) the person holding registration certificate shall provide proper facilities for storage so as to preserve the properties of samples picked up for testing;
(iv) the person holding registration certificate shall maintain records of tests for evaluation and performance carried out on all samples of medical devices and the results thereof together with pro
(1) Where any registered medical device testing laboratory fails to comply with any of the conditions of approval, or any provisions of the Act and these rules, the Central Licensing Authority, may issue a show cause notice for suspension or cancellation of the registration of the said medical device testing laboratory.
(2) On receipt of the show cause notice under sub-rule (1), the registered medical device testing laboratory shall, furnish its reply in writing, within fifteen days of the receipt of such show cause notice.
(3) After considering the reply of the registered medical device testing laboratory furnished under sub-rule (2), the Central Licensing Authority may pass an order in writing for suspension or cancellation of the registration of the said medical device testing laboratory registered under sub-rule (3) of rule 83.
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(1) Subject to the provisions of these rules, Part VI relating to "Sale of Drugs Other than Homeopathic Medicines" of the Drugs and Cosmetics Rules, 1945, shall be applicablemutatis mutandisin respect of sale of medical devices.
(2) The licence granted or renewed under Part VI of the Drugs and Cosmetics Rules, 1945 for sale of drugs, prior to commencement of these rules, shall be deemed to continue to be valid for the purpose of sale of medical devices.
(1) Notwithstanding anything contained in the Drugs and Cosmetics Rules, 1945, any person having a valid licence to sell, stock, exhibit or offer for sale or distribute by retail or wholesale, may, supply invasive medical devices to be implanted through surgical intervention to a hospital for its patient against a delivery challan:
Provided that in respect of supplies made against delivery challan of such medical devices, the licencee shall ensure that specified storage conditions are met.
(2) A cash or credit memo shall be generated for such medical devices supplied under sub-rule (1), used in the surgical intervention and record of the same shall be maintained by the licencee as per condition of licence.
(1) If a manufacturer or authorized agent, as the case may be, considers or has reasons to believe that a medical device, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user or patient during its use and therefore may be unsafe, such manufacturer or authorized agent shall immediately initiate procedures to withdraw the medical device in question from the market and patients, indicating reasons for its withdrawal and inform the competent authority the details thereof.
(2) A manufacturer or authorized agent, as the case may be, shall immediately inform the competent authority and cooperate with them, if there are reasons to believe that a medical device which has been placed in the market, may be unsafe for the patients.
(3) The manufacturer or importer or authorized agent, as the case may be, shall inform the competent author
(1) The medical devices specified in the Eighth Schedule shall be exempt from the provisions of these rules to the extent and subject to the conditions specified in that Schedule.
(2) The Central Government may, by notification, from time to time, amend or modify the entries in the Eighth Schedule.
Where a person intends to export any medical device, manufactured in India, and for that purpose, requests a certificate in the nature of free sale certificate or a certificate about quality, safety and performance in relation to that medical device as required by the authority concerned of the importing country, such person, may apply to the Central Licensing Authority for the purpose along with a fee as specified in the Second Schedule and the said authority shall, if the requirements are fulfilled, issue a certificate to the applicant.
If any document submitted by an applicant for grant of licence for import or manufacture or test licence or permit for personal use or permission to import or manufacture investigational medical device or newin vitrodiagnostic medical device or permission to conduct of clinical investigation or clinical performance evaluation is found to be misleading, or fake, or fabricated, the application, after giving an opportunity to the applicant of being heard, shall be summarily rejected.
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting misleading, or fake, or fabricated documents, may, after giving him an opportunity to show cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the Central Licensing Authority or the State Licensing Authority, as the case may be, for such period as it may deem proper.
(2) Where an applicant is aggrieved by an order made by the Central Licensing Authority or the State Licensing Authority, as the case may be, under sub-rule (1), such applicant may, within thirty days of the receipt of the order, make an appeal to the Central Government or the State Government, as the case may be, and that Government may, after such enquiry as it considers necessary, and after affording an opportunity of being heard, make such order as it may deem proper.
(1) The fees prescribed under these rules, in case of application made to the Central Licensing Authority, shall be paid through challan or by electronic mode, in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch of Bank of Baroda, or any other bank, notified by the Ministry of Health and Family Welfare in the Central Government, to be credited under the Head of Account "0210- Medical and Public Health, 04-Public Health, 104-Fees and Fines.
(2) Where the fee specified is payable to the State Licensing Authority, the same shall be paid through a challan or by electronic mode as may be specified by the State Government concerned.
The Forms prescribed under these rules may be suitably modified for conversion into digital forms by the Central Drugs Standard Control Organization and such modification shall not require any amendment in these rules.
The provisions of these rules shall have effect, notwithstanding anything inconsistent therewith contained in the Drugs and Cosmetics Rules, 1945.
Notwithstanding the non-applicability of the Drugs and Cosmetics Rules 1945, for the substances and devices referred to in rule 2,-
(i) the licence or registration certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules, 1945, prior to commencement of these rules, shall be deemed to be valid till its expiry or for a period of eighteen months from the date these rules are notified, whichever is later, under the corresponding provisions of these rules;
(ii) new drug approval, or things done or any action taken or purported to have been done or taken, including any rule, notification, inspection, order or notice made or issued or any appointment or declaration made or any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed
[Seerule 4]
Parameters for classification of medical devices andin vitrodiagnostic medical devices
Part I
Parameters for classification of medical devices other thanin vitrodiagnostic medical devices Basic Principles for classification
(i) Application of the classification provisions shall be governed by the intended purpose of the device.
(ii) If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.
(iii) Software, which drives a device or influences the use of a device, falls
[See rules 13(5), 13(7), 20(2), 21(2), 25(3), 29(1), 31(1), 34(2), 34(4), 35(2), 37, 40(2), 42(1), 51(2), 59(2), 63(1), 64(1), 81(1), 84, 91]
Fee payable for licence, permission and registration certificate
Sr. No. | Rule | Subject | In rupees (INR) except where specified in dollars ($) |
(1) | (2) | (3) | (4) |
[See rules 13(5), 13(9), 14, 15, 20(4), 20(6)]
Documents required for registration of Notified Body, its duties and functions.
Part I
Documents to be furnished along with application in Form MD-1 for grant of certificate of registration
1. A Notified Body shall furnish duly signed copy of the following documents to the Central Licensing Authority.
(i) Constitution details of the Notified Body;
(ii) Brief profile of the organization and business profile related to audit of medical device manufacturing sites;
(iii) Accreditation Certificate issued by the National Accreditation Body referred to in the rule 11.
[See rule 20(2), 21(2), 34(2), 34(4), 63(1) and 64(1)]
Documents required for grant of licence to manufacture for sale or for distribution or import
Part I
Power of Attorney
(To be authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through apostille)
Power of Attorney to accompany an application for issuance of import licence
I ...................... working as ........................... authorized to sign this Power of Attorney, on behalf of M/s ....................................... (full address/ telephone no., e-mail) having manufacturing site at ........................
[See rule 20(3), 20(5), 20(8), 22(i)]
Quality Management System for medical devices andin vitrodiagnostic medical devices
1. General Requirements—
1.1. This schedule specifies requirements for a quality management system that shall be used by the manufacturer for the design and development, manufacture, packaging, labeling, testing, installation and servicing of medical devices andin vitrodiagnostic medical devices. If the manufacturer does not carry out design and development activity, the same shall be recorded in the quality management system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions.
1.2. If any requirement in paragraph 7 (product realization) of this Schedule is not applicable due to the nature of
[See rules 26(iii), 26(iv), 38(v) and 38(vii)]
Post approval change
(A) Changes in respect of following shall be considered as major change in,-
1. material of construction;
2. design which shall affect quality in respect of its specifications, indication for use; performance and stability of the medical device;
3. the intended use or indication for use ;
4. the method of sterilization;
5. the approved Shelf life;
6. the name or address of,-
(i) the domestic manufacturer or its manufacturing site;
&nb
[See rules 51(1), 51(2), 53(ii), 53(v), 59(3)]
Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation
1. Application for permission. -
(1) an application in Form MD-22 shall be made to the Central Licensing Authority along with following data in accordance with tables, namely:-
(i) Design analysis data as per Table 1.
(ii) Bio-compatibility and Animal Performance Study as per Table 2.
(iii) Information specified in Table 3 shall be submitted along with Investigator's Brochure as prescribed in Table 4, Clinical Investigational Plan as prescribed in Table 5, Case Report Form as prescribed in Ta
(See rule 90)
Exemptions
S.N. | Class of medical devices | Extent and conditions of exemption | |
1 | Custom made device. | All provisions of Chapter IV and Chapter V of these rules, subject to the condition that the device is being specifically made in accordance with a duly qualified medical practitioner's written prescription under his responsibility, in accordance with specific design, characteristics and the sa | |
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