India Market Access for Medical Device

REGULATORY AGENCY

• Central Drugs Standard Control Organisation (CDSCO, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

REGULATIONS

• Some medical devices are regulated under the Drugs & Cosmetics Act 1940, i.e. their treatment is similar to that of drugs/medicines. Such devices require approval from CDSCO. 
• For imported devices, registration and an import license is required. 
• For locally manufactured devices, a grant of license is required after evaluation. 
• For the sale of devices, appropriate sale licenses are required. 
• CDSCO* has uploaded the proposed requirements for future regulatory control of medical devices.\

* Under Schedule M-III, the proposed regulation follows the same structure as the EU Medical Device Directive 93/42/EEC. Device classifications A, B, C and D are harmonised with the Global Harmonisation Task Force. The proposed requirements are summarised as follows: 

• Class A and Class B device manufacturers need not obtain a manufacturing license but are required to register with the CLAA. For Class B devices, it is also required that a Notified Body assesses and certifies the manufacturing facility for quality systems. 
• Class C and Class D devices require certification by a Notified Body with regard to design and manufacturing. Manufacturers are then required to apply for a manufacturing license and submit essential documents to CLAA. For Class D devices, it is also required that the manufacturing facility be jointly inspected by CLAA and the state licensing authority.

GUIDELINES

• A local representative is required.

IMPORT REGISTRATION REQUIREMENTS 

• Submission of applicant details and product information. 
• Evidence of approval from other country(s) regulatory agency(s) and related certification if any. 
• Master file (details of Good Manufacturing Practices employed). 
• Post-market surveillance.
• Undertaking of conformity with respect to requirements in the country of origin.

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