This article talks about the overall process of registration of medical devices in India.
At the federal government level, medical device registration are processed by the Central Drug Standards Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. Manufacturers can leverage their approvals in the US, Canada, Europe, Australia or Japan for Registration of Medical Devices in India.
Background
Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical devices entering India must be in compliance with the Indian Medical Device Regulations set forth by the CDSCO. The CDSCO is responsible for medical device registration and regulation of New Drugs and Clinical Trials in the country, laying down the standards for drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
For marketing of imported medical devices in India, medical device Registration Certificate in Form-41 and Import License in Form-10 are required under the Drugs and Cosmetics Rules. Following the submission of the Regulatory Dossier, the CDSCO officials review the documentation and send Query Letters to the Authorized Indian Agent for clarifications on the documents submitted. READ ALSO: Documents required for Notified Medical Device Registration in India. Following the successful addressing of the Query Letters, the Registration Certificate is issued which is valid for a three year period.
Notified Medical Devices
For Registration of Medical Devices in India, 21 devices categories have been listed as ‘Notified Devices’ by the CDSCO. However, devices which require registration extends beyond the 21 listed. Regulatory team at Morulaa can assist in determining whether your products requires Registration 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.
Time Line
The time period for Registration of Medical Devices in India is generally 6-9 months, post the submission of complete and accurate documentation and fees to obtain the registration certificate. Registration is valid for 3 years and renewal applications need to be submitted 6 months in advance of expiry. READ ALSO: Step by Step Process to Register Your Medical Device in India.
Regulatory Challenges for Medical Devices in India
Manufacturers are attracted to the Indian market due to its reliance on imports. However the challenge is that the Regulatory Body in India is currently at its infancy and rules may be updated within short periods resulting in uncertainty over the approval process. It might be a good idea to keep an eye at our everyday news.
Contact Harshita Gupta for additional information.