Diligence Certification

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...

  Introduction: presence globally but their shipment got stuck at Mumbai port during their attempted launch in India. Why? Because they did not have a CDSCO Import License for Cosmetic products .   This happens much more frequently than one would think. Whether you are a new Indian startup marketing herbal shampoos or a large multinational importing luxury perfumes, you cannot afford to ignore the proper Cosmetic License. Why? Because it is compliance!! What do I mean by compliance? All cosmetics sold in India require a license according to the compliance requirement of India's Drugs and Cosmetics Act, 1940. Let's explain the meaning of a license, why the license is important, and how to avoid unnecessary delays with the license process. What is a Cosmetic License in India? A Cosmetic License is the official permission given to an organization by the Central Drugs Standard Control Organization (CDSCO) allowing them to manufacture, import, or distribute cosmetics in India. It ...