Notified Medical Devices:

Medical Device Registration Process in India

Background

The recent political changes resulting in a pro-business environment has made manufacturers from the Healthcare industry stand up and take notice of India. The Industry is expected to grow at a high CAGR of 15 percent for the next five years and is predicted to become a US $155 billion market by 2017. This growth rate is expected to place the Healthcare sector at the top of the revenue generating sectors in the country. The key players of the wide and diverse spectrum of Indian healthcare are Medical devices, pharmaceuticals, biotechnology, and more recently the medical tourism sector. The rapidly growing economy of India makes it one of the strong partners in the BRICS. Promising economic growth, rising disposable incomes, large pool of English speaking and talented human resources, shift from communicable diseases to lifestyle related diseases has made the Healthcare industry in India an attractive investment option. Growth is seen across all sectors of healthcare: medical devices, pharmaceuticals, labs, hospitals, IT services and other providers.

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 Central Drug Standards Control Organisation (CDSCO). The CDSCO is responsible for approval 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. The CDSCO has published a list of notified medical devices India to serve as guidelines for the process.

For marketing of notified medical devices India, 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. Following the successful addressing of the Query Letters, the Registration Certificate is issued which is valid for a three year period.

Morulaa HealthTech specializes in registering medical devices with the CDSCO in India. Our team of experts specialize in the notified medical device India, registration process and can assist in grouping your products, determining feasibility, labeling requirements and timeframe to market. Officially there are 21 notified medical devices India. However, it is important to note that several medical devices are still classified as drugs in India as per the Drugs and Cosmetics Act and hence they require regulatory approval.

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.

Below is an exhaustive list of notified medical devices India which Morulaa assists in obtaining regulatory approval.