MD-42 License for Manufacturers: Key Requirements & Compliance Overview The MD-42 license is issued by CDSCO to authorize the manufacturing of Class C and Class D medical devices in India. This license ensures that manufacturers follow stringent quality, safety, and regulatory standards before their products reach the market. To obtain an MD-42 license, applicants must demonstrate GMP compliance, maintain a qualified technical staff, and submit detailed device documentation through the SUGAM portal. Proper facility inspection, adherence to ISO 13485, and accurate file submissions are crucial for approval. The MD-42 license is essential for organizations looking to produce high-risk medical devices legally and responsibly.