MEDICAL DEVICES RULES, 2017

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Preliminary G.S.R. 78(E)

R.1 Short title and commencement

R.2 Application

R.3 Definitions

R.4 Classification of medical devices

R.5 Medical device grouping

R.6 Essential principles for manufacturing medical devices

R.7 Product standards for medical device

R.8 Licensing Authorities

R.9 Delegation of powers of Licensing Authorities

R.10 Controlling officer

R.11 National Accreditation Body

R.12 Functions of National Accreditation Body

R.13 Notified body

R.14 Duties of Notified Body

R.15 Procedure to be adopted by Notified Body

R.16 Fees to be charged by Notified Body

R.17 Suspension and cancellation of registration certificate of Notified Body

R.18 Medical Device Testing Officer and Medical Device Officer

R.19 Central medical device testing laboratory

R.20 Application for manufacture for sale or for distribution of Class A or Class B medical device

R.21 Application for manufacturing Class C or Class D devices

R.22 Requirements for grant of manufacturing licence or loan licence

R.23 Inspection for grant of licence or loan licence for Class C or Class D medical device

R.24 Inspection report

R.25 Grant of licence or loan licence to manufacture for sale or for distribution

R.26 Conditions for manufacturing licence or loan licence

R.27 Change in constitution

R.28 Unannounced inspection by State Licensing Authority

R.29 Validity of licence

R.30 Suspension and cancellation of licence

R.31 Test licence to manufacture for test, evaluation, clinical investigations, etc.

R.32 Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc.

R.33 Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc.

R.34 Application for grant of import licence

R.35 Inspection of overseas manufacturing site

R.36 Grant of import licence

R.37 Validity of licence

R.38 Conditions to be complied with by Licence holder

R.39 Fresh application in case of change in constitution

R.40 Test licence for import for test, evaluation, clinical investigations, etc.

R.41 Grant of test licence for import for test, evaluation, clinical investigations, etc.

R.42 Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient

R.43 Import of medical device for personal use

R.44 Labeling of medical devices

R.45 Exemption of labeling requirements for export of medical devices

R.46 Unique device identification of the medical device

R.47 Shelf life of medical devices

R.48 Labeling medical device or a newin vitrodiagnostic medical device for purpose of test, evaluation, clinical investigations, etc.

R.49 Conduct of clinical investigation

R.50 Application of rule 122DD of Drugs and Cosmetics Rules, 1945 with regard to Ethics Committee

R.51 Application for grant of permission to conduct clinical investigation

R.52 Permission to conduct clinical investigation

R.53 Conditions for permission

R.54 Suspension, cancellation, etc. of permission

R.55 Medical management and compensation related to clinical investigation

R.56 Powers of search and seizure, etc.

R.57 Maintenance of record

R.58 Disclosure of name, address, etc., of persons involved in clinical investigation or clinical performance evaluation

R.59 Permission to conduct clinical performance evaluation for newin vitrodiagnostic medical device

R.60 Conditions for permission to conduct of clinical performance evaluation

R.61 Suspension or cancellation of permission

R.62 Medical management

R.63 Permission to import or manufacture medical device which does not have its predicate device

R.64 Permission to import or manufacture newin vitrodiagnostic medical device

R.65 Condition of permission to import or manufacture medical device which does not have its predicate device and newin vitrodiagnostic medical device

R.66 Duties of Medical Device Testing Officer

R.67 Test or evaluation of sample under sub-section (4) of section 25 of the Act

R.68 Procedure to be adopted by medical device testing officer on receipt of sample

R.69 Application for test or evaluation of medical device

R.70 Duties of Medical Device Officer

R.71 Prohibition of disclosure of information

R.72 Form of order not to dispose of stock

R.73 Prohibition of sale

R.74 Form of receipt for seized medical devices, record, register, documents or any other material objects

R.75 Manner of certifying copies of seized documents

R.76 Purpose for which samples have been taken

R.77 Form of receipt for samples of medical devices where fair price tendered is refused

R.78 Procedure for dispatch of sample to medical device testing officer

R.79 Confiscation of medical devices, implements, machinery, etc.