This article talks about the overall process of registration of medical devices in India.
At the federal government level, medical device registration is 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 to comply with medical device regulations 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 India set forth by the CDSCO. Appointing a Medical device authorized representative India is now an essential step in ensuring compliance and streamlining the regulatory process. The Central Drug Standards Control Organisation (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 bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act.
For marketing of imported medical devices in India, compliance with medical device regulations India is essential. A medical device Registration Certificate in Form-41 and Import License in Form-10 are required under the Drugs and Cosmetics Rules. As part of the CDSCO medical device registration process India, regulatory services in India play a crucial role in assisting manufacturers with the 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 device categories have been listed as ‘Notified Devices’ by the Central Drug Standards Control Organisation (CDSCO), as defined under the medical device rules 2017 India. However, devices which require registration extend beyond the 21 listed. The regulatory team at Morulaa can assist in determining whether your products require Registration of Medical Devices in India. Compliance with the CDSCO import license form MD14 India is necessary for medical devices. Devices which require registration in India include spinal needles, cochlear implants, annuloplasty rings, tracheostomy 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. Engaging a Medical device authorized representative in India can help streamline the submission process and ensure compliance with regulatory requirements. Registration is valid for 5 years and renewal applications need to be submitted 6 months in advance of expiry, in compliance with the medical device rules 2017 India. 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 the CDSCO medical device registration process in India may undergo updates within short periods resulting in uncertainty over the approval process. It might be a good idea to keep an eye on our everyday news.
Contact Harshita Gupta for additional information.