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 regulation of medical devices 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. A detailed list of notified medical devices in India can be found here.
Statistics show that manufactures from USA, Germany, Swizerland, France, China, and Japan are among the top investors in this market place. A brief report covering key statistics of the CDSCO can be found by visiting our blog article: Statistics & Figures: Medical Device Registration India.
For the registration of medical devices in India, Morulaa HealthTech provides an end to end solution from dossier preparation, submission, follow-up with the CDSCO, labeling requirements, and obtaining the relevant certification. To register your medical device in India, you must have an authorized Indian agent. The authorized Indian agent could be (1) a distributor (2) direct subsidiary (3) Independent agent
Manufacturers with no local presence in India must appoint an authorized Indian agent or distributor to manage registration as well as post-market surveillance requirements. The authorized agent acts as a liason between the government and the overseas manufacturer.
Reasons for not appointing a distributor or sales agent as an in-country representative:
- Design information might have to be disclosed to the distributor during the dossier compilation process.
- Focus of the distributor is primarily on sales and marketing. Having them handle regulatory affairs could be an additional distraction.
- Issuance of the certificate in the name of the distributor means you are ‘locked’ with the distributor for a minimum period of 3 years. Should you wish to change or add distributors you would have to start the process all over, as there is no option for registration certificate transfer in India.
- Incident reporting / recalls can create a conflict of interest with your distributor.
Roles and responsibilities of an authorized agent:
- Must be a resident of India with experience in the healthcare industry
- Holds the Power of Attorney to submit medical device registration documents to CDSCO
- Must hold Drug Wholesale Licenses 20- B and 21-B
Tasks we perform as an India Authorized Agent:
- As the in-country representative, Morulaa will be the “registration holder”. We will assist distributors for the product(s) to apply with the CDSCO to import and sell the product(s) in India.
- Morulaa mailing address and contact details are used for device submissions to allow the CDSCO to liason with overseas manufacturers with no local presence in India.
- Provide documents for inspection and review as and when requested by the CDSCO on behalf of overseas manufacturers.
- Coordinate and report adversaries, product recalls, post market surveillance (PMS) data.