To legally sell or distribute Class A and B medical devices in India, businesses must obtain the MD-42 license under the Medical Devices Rules, 2017. This license is issued by the State Licensing Authority and involves specific infrastructure, documentation, and personnel requirements. From having qualified technical staff to maintaining proper storage facilities, compliance is crucial. At Agile Regulatory, we guide you through every step—from preparing the application to final approval—ensuring your business meets all MD-42 license requirements smoothly and without delay. Stay compliant and grow confidently in India’s regulated healthcare market.