In India, to import and distribute medical devices, the importer must first complete Form MD 14, which is the application for the registration of medical devices with the Central Drugs Standard Control Organization (CDSCO). This form requires detailed information about the medical device, such as its classification, intended use, manufacturing details, safety data, and quality management certifications like ISO 13485, along with a free sale certificate from the country of origin. Once the device is registered, the importer must then apply for Form MD 15 to obtain a Medical Device Import License, which includes information about the importer, the registered device(s), proof of authorization from the manufacturer, and compliance with Indian regulatory standards. The CDSCO reviews these forms, and upon approval, issues the import license, allowing the legal importation and distribution of the device in India. The process ensures that medical devices comply with the Medical Device Rules, 2017 under the Drugs and Cosmetics Act, and may include inspections or testing, depending on the device’s risk classification.