Medical Device Registration in India

India

The information on this page is valid and current as of April 2018. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


Regulatory Authority:
Central Drugs Standard Control Organization (CDSCO). two Authorities are responsible for issuing certifications: the State Licencing Authority (Class A and B devices) and the Central Licencing Authority (Class C and D devices)

Classification:
Class A, B, C, D

Procedure:
Medical devices shall be registered with the Regulatory Authority in order to be marketed in India. As regards Class A and B medical devices it is necessary to submit the documentation to the State Licencing Authority which will issue the Form MD-5 certification. While Class C and D devices documentation shall be submitted to the Central Licencing Authority which will issue the Form MD-7 (for Class C devices) and Form MD-8 (for Class D devices).

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Applicant:
The foreign manufacturer shall appoint an Indian Authorized Representative

Timeframe and fees:
Fees to be directly paid to the Regulatory Authority and registration timeframes vary according to the device Class.

Labeling and documentation language:
Documentation and labeling shall be provided in English.

Useful information:
The Medical Device Rule, the new Indian Regulation, came into force on January 1, 2018. As of January 1, 2022 all medical devices shall bear the Unique Device Identifier (UDI). Devices registration certificates or import licenses issued in accordance with the previous regulations shall remain valid until their expiry date or no later than July 31, 2018.

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