Medical Device – For Manufacturers
Medical Device – For Manufacturers
Pertaining to the New Medical Rules 2017, all medical devices have been classified into four different categories. Namely, Class A, Class B, Class C and Class D. Any company which intends to manufacture these devices for sale or distribution must apply for a manufacturer’s license with CDSCO.
Class A and Class B devices are considered as low risk and moderate risk devices. The application for manufacturing medical devices falling under these classes has to be filed with the State Licensing Authority. Whereas, Class C and Class D devices are classified as High and Very High Risk devices. The application for manufacturing these has to filed with the Central Licensing Authority.
CDSCO has also defined different application fees for each category of medical devices. Our professionals at CliniExperts have the right knowledge, skill set and experience to help you with filing an application for obtaining manufacturers license. Our experts help you in reducing hassle and expediting your application process.
Permission to Manufacture or Permission for loan license to manufacture Class A & B Medical Device in India from State FDA (Form MD-5 and Form MD-6)
Class A and Class B devices are classified as low risk and moderate risk devices. The License for manufacturing these devices can be applied and obtained at the State Licensing Authority. The application is made using form MD-5 whereas the permission is granted through form MD-6.
CliniExperts has presence across all the states in India to help you with filing an application with your respective state licensing authority. Our experts will take the pain off your head by helping you create and file the application. We offer end-to-end customer support for our clients.
Permission to Manufacture or Permission for loan license to manufacture Class C & D Medical Device in India from CDSCO (Form MD-9, Form MD-10)
Class C and Class D medical devices are classified as High Risk to Very-High Risk medical devices. The application procedure for these devices is more stringent and complex as compared to Class A and B devices. The application for the manufacturer license is filed at the Central Licensing Authority.
Filing application for these devices is a hectic and complex procedure. Our team at CliniExperts helps simplify and expedite this process through regular follow up meeting and proper submission of documents.
Permission for test license to manufacture Medical Device (Form MD-12, Form MD-13)
Manufacturers may at times require license for production of medical devices intended for the purpose of testing, training, clinical evaluation or demonstrations. For this an appropriate test license has to be obtained by the Central Licensing Authority for manufacturing such devices. The test license can be obtained for any class of medical devices.
Our technical team at CliniExperts helps such clients by easing the process of filing the application and obtaining the test license.
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For assistance on any of the above services, please feel free to reach us at +91-767 20 05 050 or email us at contact@cliniexperts.com