BR and Associates

  The cosmetics market in India is rapidly growing and attractive due to strong consumer demand and expanding global trade opportunities. However, no cosmetic product can be manufactured, imported, or sold in the Indian market unless it is approved by the Central Drugs Standard Control Organization (CDSCO). The procedure for cosmetic registration in India ensures that these products are safe, high-quality, and compliant with Indian regulations. The Regulatory Authority and its Domain The Drugs and Cosmetics Act, 1940, read with the Drugs and Cosmetics Rules, 1945, governs cosmetic registration in India . The CDSCO is the national regulatory authority that grants clearance for cosmetics to be imported and sold in the Indian market. This includes skincare, haircare, personal hygiene items, perfumes, and a variety of beauty products. Apart from cosmetics, CDSCO also regulates medical devices. The framework of CDSCO for Medical Device Registration shares similarities in documentatio...

  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...