CDSCO registration

Indian Medical Device Rules: 2017

The government of India is responsible for developing regulatory aspects to ensure the efficacy, safety, requirements and performance of medical devices in India. The Central Drugs Standard Control Organization (CDSCO) is mainly responsible for regulation of medical devices in India under Ministry of Health and Family Welfare. Before the company’s products are introduced into the Indian market, all products must be registered with the CDSCO.

Medical Devices in India are regulated by the Central Drugs Standards Control Organization (CDSCO) as per the provisions of Medical device rules 2017 issued by the Government under the Drugs and Cosmetics Act, 1940 (“D&C Act”). The Indian Medical Devices Rules 2017 consists of 12 Chapters and 8 Schedules.

On February 15, 2023, CDSCO released the Medical Device Rules 2017 Amendment.

How Alceon Can Help For CDSCO:

To find out the medical device classification as per the Indian Medical Devices Rules 2017.
To help with the below licence registration:
1. Test licence
2. Manufacturing licence
3. Loan to manufacturing licence
4. Import licence
5. Import test licence
6. Wholesale licence
To prepare Site master file, Device master file and QMS as per the schedule 4 and 5^th IMDR 2017 requirement.
Training on IMDR 2017.