In India, any medical equipment manufacturer or importer dealing in medical devices must obtain a mandatory medical devices licence to legally manufacture, sell, or import these products. The licensing process involves detailed procedural and regulatory compliances, including mandatory testing of medical devices from NABL-accredited laboratories.
Entities or individuals interested in importing medical devices or manufacturing them in India must submit their application in FORM MD 14/MD 16 to the State Licensing Authority, along with the prescribed fees and supporting documents.
Compliance Under Medical Devices Rules, 2017
The application must include all necessary documentation and declarations, as required under the Medical Devices Rules, 2017. Upon receiving the application, the State Licensing Authority conducts a thorough review, which may include site inspections, scrutiny of documents, and audits of manufacturing facilities.
Only after the authority is fully satisfied that the applicant has complied with all legal and technical requirements, the medical devices licence is granted. In cases where compliance is not met, the application may be rejected.
Expert Assistance for Hassle-Free Licensing
At Lex Rikai, our regulatory experts specialize in simplifying the complex licensing process, ensuring you meet all legal obligations smoothly. Whether you are a medical equipment manufacturer seeking a new license, or a business engaged in importing medical devices into India, we offer expert guidance to ensure accurate documentation, timely filing, and full compliance.
Additional Support – Cosmetics Import Licensing
For businesses looking to expand into cosmetics, Lex Rikai also provides advisory services for cosmetics import in India. Our team helps you navigate licensing requirements, ensuring you meet all regulatory standards under the Drugs and Cosmetics Act.
For More information please contact us at: info@lexrikai.in