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MDR 2017 Document Viewer

Government of India · Ministry of Health & Family Welfare

Medical Devices Rules, 2017 (G.S.R. 78(E))

11 of 11 sections shown

Rule 3

Definitions

In these rules, unless the context otherwise requires, 'Authority' means the Central Licensing Authority or the State Licensing Authority; 'investigational medical device' means a medical device which has not been approved for marketing; 'notified body' means a body accredited under rule 13.

Rule 4

Classification of medical devices

Medical devices shall be classified based on intended use, risk and other parameters into: low risk — Class A; low moderate risk — Class B; moderate high risk — Class C; high risk — Class D, in accordance with the First Schedule.

Rule 13

Registration of notified body

A body intending to carry out audit of manufacturing sites of Class A and Class B medical devices shall apply for registration in Form MD-1 through the online portal of the Central Government.

Rule 20

Application for licence to manufacture Class A or Class B

An application for grant of licence to manufacture for sale or distribution Class A or Class B medical devices shall be made to the State Licensing Authority in Form MD-3.

Rule 21

Application for licence to manufacture Class C or Class D

An application for grant of licence to manufacture Class C or Class D medical devices shall be made to the Central Licensing Authority in Form MD-7, accompanied by the Plant Master File and Device Master File as specified in the Fourth Schedule.

Rule 34

Application for import licence

Any person who intends to import medical devices shall make an application in Form MD-14 through an authorised agent having a licence to manufacture or wholesale, accompanied by the fee specified in the Second Schedule and documents specified in Part II of the Fourth Schedule.

Rule 36

Grant of import licence

The Central Licensing Authority shall, after scrutiny of documents, and where necessary inspection of the overseas manufacturing site, grant a licence in Form MD-15 or reject the application within a period of ninety days from the date of application.

Rule 44

Labelling of medical devices

Every medical device shall bear a label containing the name of the device, details necessary to identify the device, name and address of the manufacturer and importer, import licence number, lot or batch number, and date of manufacture and expiry.

Rule 63

Permission to import or manufacture new medical device

No person shall import or manufacture for sale a new in vitro diagnostic or investigational medical device unless permission is granted by the Central Licensing Authority in Form MD-27 or MD-29, after review of clinical investigation data.

Fourth Schedule Part II

Device Master File

The Device Master File shall include executive summary, device description, product specification, labelling, design and manufacturing information, essential principles checklist, risk analysis (ISO 14971), verification and validation including biocompatibility (ISO 10993), and post-market surveillance data.

Fourth Schedule Part III

Plant Master File

The Plant Master File shall include general information on the manufacturer, personnel, premises and facilities, equipment, sanitation, production, quality assurance per ISO 13485, storage and distribution records, and complaint handling procedures.

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