New Clarifications for Medical Devices in India

In September 2007, India’s medical regulatory body, the Central Drugs Standard Control Organization (CDSCO), released an “Additional Clarification to Guidelines for Import Registration and Manufacture of Medical Devices”. This Clarification covers several topics, from regulating more categories of medical devices to setting new clinical trial requirements for specified medical devices.

Under India’s Drugs and Cosmetics Rules, a Free Sale Certificate (FSC) issued by the national regulatory authority in the country of origin is required for medical device registration. The Clarification specifies that for medical devices manufactured in the European Union, CE certification will be required on top of approval for manufacture and free sale in the country of origin. Devices manufactured in the US, Australia, Japan, or Canada must submit product approval by their national regulatory authority (US FDA, etc.) as well as an FSC.

However, for medical devices manufactured in any countries other than those specified above, domestic product approval and an FSC will not be sufficient. These devices will also need to show product approval from the US FDA, TGA Australia, Health Canada, Japan’s Ministry of Health, Labor and Welfare, or CE certification.

To be subject to Indian regulatory standards, medical devices must be specified as drugs under the Drugs and Cosmetics Act. In the Clarification, CDSCO expanded the devices in this category. All peripheral stents must now be registered to be imported or manufactured domestically. In addition, all cardiac patches and occluders used in interventional cardiology will also require registration. To enter the country, these products require both a valid Registration Certificate and a Form 10 license (import license).

Finally, imported drug-eluting stents are now subject to new requirements in India. Overseas manufacturers wishing to import drug-eluting stents into India will need to conduct a six-month local clinical trial with 100 patients to receive approval. If the stents have no history of use in any country, the manufacturer will have to conduct a 12-month local clinical trial with 100 patients.