In India, the institution that oversees medical device regulations is the Central Drug Standard Control Organization (CDSCO), which is part of the Ministry of Health and Family Welfare. The Medical Device Rules, 2017, which went into effect on January 1, 2018, is the new legal framework by which medical devices and IVD devices are regulated in India.
Under this new framework, only certain medical devices and IVDs require registration– most being those of higher risk called “notified devices.” Here you can not only find the fifteen “notified devices,” but also an extensive list explaining the classifications of specific, common devices that have changed under the new policy. The CDSCO classifies medical devices into four categories: Class A, Class B, Class C, and Class D, with Class A being the lowest risk and Class D being the highest risk.
Listed below is a general guide for how to register your medical devices in India.
For all Classes:
- Appoint an India Authorized Agent to work with the CDSCO on your behalf. This agent must have valid licenses from Forms 20B and 21B/21C and obtain the label of Power of Attorney in order to legally manage the progression of your device’s registration and importation in India.
- Certain in-vitro diagnostics devices (IVDs) will require in-country performance tests, which are conducted through the National Institute of Biologicals.
- Complete Form MD-15, the device registration application, which includes the device’s technical information, manufacturing facility information (to register the facility/facilities being used to produce the device), ISO 13485 certificate, IFU, and any testing results and clinical data. In addition, provide proof of approval from the United States, Australia, Canada, European Union, and/or Japan, as well as proof of approval in the device’s country of origin (if applicable). All documents should be in English.
- Send applications to the CDSCO and pay the application fees.
- The CDSCO will review applications, but may request the submission of a technical presentation or a Subject Expert Committee (SEC) review.
- If approved, the CDSCO will issue a Registration Certificate. Although this certificate does not expire, fees are required to be paid every five years in order to maintain the validity of the certificate.
- Once the certificate is obtained, your product’s India Authorized Agent may import products into India!