BR and Associates

 The Indian healthcare and cosmetic market trends have tremendously increased and created immense growth opportunities for manufacturers, importers, and distributors. Increasingly, regulation for safety, quality, and compliance has become essential with the proliferation of this industry. The Central Drugs Standard Control Organization (CDSCO) , operating under the Ministry of Health and Family Welfare, is the national regulatory authority in India, responsible for approval, licensing, and monitoring of the import of medical devices and cosmetics. Knowledge in CDSCO medical device registration and the requirements for cosmetic import and registration is very important for businesses intending to set foot in or expand in India. Noncompliance not only attracts penalties but also affects credibility with consumers and professionals. Medical Devices under CDSCO Medical devices, which are essential to the healthcare ecosystem within India, range from simple instruments su...

  Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) to ensure safety, quality, and efficacy. The CDSCO Medical Device Registration process is an obligatory step for manufacturers and importers who wish to market or sell their devices in the country. This verification mechanism ensures that each device is safe to operate and compliant with global healthcare standards and patient safety norms. Understanding the CDSCO for Medical Device Regulation The Central Drugs Standard Control Organization is the governing authority for medical device regulations under the Drugs and Cosmetics Act, 1940, framed within the Medical Devices Rules, 2017. These rules categorize devices into four risk-based classes: Class A – Low risk (e.g., Surgical dressings) Class B – Low to moderate risk (e.g., Infusion sets) Class C – Moderate to high risk (e.g., Orthopedic implants) Class D – High risk (e.g., Heart valves, Pacemakers) Each category has distinct req...