CDSCO Medical Device Registration in India
The Central Drugs Standard Control Organization (CDSCO) is responsible for medical device regulation in India as indicated in the Medical Devices Rules, 2017. In India, a medical devices classification is based on risk, ranging from A (lowest risk) to D (highest risk). Registered manufacturers and suppliers of medical devices cover Class B to Class D; moderate to high-risk medical devices and require registration when importing or manufacturing a medical device. Applying for registration will guarantee that a medical device is safety, effective and acceptable quality, and meets all safety and quality assurance requirements established before a medical device can enter the Indian marketplace. Introduction India’s rapidly expanding healthcare market, estimated at about USD 200 billion in 2023, is expected to grow to USD 370 billion by 2025, offers a significant opportunity for medical device manufacturers and importers. But becoming a part of this rapidly growing market comes wit...