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).


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.