Indian Certification of Medical Devices Manufacturing/Equipment License

Corpzo24 Apr, 2025Business

The certification of medical device manufacturing in India falls under the Medical Devices Rules, 2017, regulated by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers are required to obtain a manufacturing license for Class A, B, C, and D medical devices, depending on the risk classification of the product. This ensures that the devices adhere to safety, efficacy, and performance standards set by Indian regulatory authorities.