The Indian healthcare market is rapidly becoming an attractive market for medical device manufacturers. The Central Drugs Standard Control Organization (CDSCO) is governed by the Drugs and Cosmetics Act (1940) and Rules (1945). The CDSCO is responsible for the notified medical device registration in India. Medical devices which require registration in India include spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. (Detailed list of notified medical devices in India).

Checklist for Notified Medical Device Registration in India:

A detailed technical dossier is required for the registration process in India. Manufacturers who have got a home approval (FDA or CE) can use them to leverage their device registrations in India. The Registration certificate is valid for a period of 3 years and need to be re-applied within 6-9 months prior to its expiry date. With medical devices rapidly growing into a global one, the regulatory team in your company can have a tough job preparing country-specific dossiers. Each country has its own rules some require different stages of clinical trials even though you might have the CE/ FDA/Japanese approvals and some are document driven. Morulaa provides direct assistance in obtaining registration of notified medical devices, IVDs, neutraceuticals and cosmetics. (Indian Authorized Agent)

The following documents have to be submitted for notified medical device registration in India. A checklist for document requirements can be downloaded here. The checklist for document requirements with the CDSCO for notified medical device registration is found below.

  • Form 40
  • TR6 Challan
  • Power of Attorney
  • Schedule D(I)
  • ISO 13485 Certificate
  • Full Quality Assurance Certificate
  • CE Design Certificate
  • Declaration of Conformity
  • Free Sale Certificate
  • Other Regulatory Approvals
  • PMS report
  • Plant Master File
  • Device Master File

Details about document requirements and things to keep in mind when preparing the dossier coming up in the next blog.