Manufacturing of class C and D medical devices is subject to more stringent laws by the government. Since these classes of medical devices are under the high to very high risk category, the subject lies under the central government authorities.
For manufacturing Class C and/or D medical devices, or for getting permission for a loan license to manufacture such products, the company needs to file an application with CDSCO (Central Drugs and Standard Control Organisation).
An application for grant of license to manufacture Class C and Class D medical device for sale and distribution can be filed using Form MD-7 and the license to manufacture Class C and Class D medical device can be obtained in Form MD-9.
Similarly, an application has to be made using Form MD-8 for the grant of loan license to manufacture Class C and Class D medical device for sale and distribution and the susequent permission for loan license to manufacture Class C and Class D medical device can be obtained in Form MD- 10. Since Class C and D medical devices are categorized as high risk, the application procedure is very stringent.
However, at CliniExperts, our team of experts possesses the necessary knowledge and skills to help you file an application with CDSCO with minimal effort.
The foremost document to be included with the application is a cover letter which gives an overview of the application, describing it purpose. Crafting the cover letter should be done carefully as even a minor mistake can get your application rejected. This is where we come in to help our clients.
Furthermore, the manufacturing license of an Indian agent and the constitution details of domestic manufacturer or authorized agent are to be attached with the cover letter.
The applicant must also hold a test license obtained for testing and generation of quality control data for the medical device.
An essential principles list must also be included with the package which defines any foreseeable or known hazards and estimate the associated risks with the usage of the medical device. This list helps the authorities to understand the level of risk associated with a medical device seeking registration for manufacturing.
A document defining the substantial equivalence of the medical device to a predicate device must also be included with the package.
Finally, the device master file, and plant master file defining the technical, clinical, safety and manufacturing related facts and information shall be attached with the application.
Creating and sorting these documents is a lot of hassle for the applicant. Hence leaving it to the experts is the only viable option. We at CliniExperts will help you to file an application for manufacturing or obtaining loan license for manufacturing of Class C and D medical devices in India.
For more information on the same or any query, please feel free to reach us at contact@CliniExperts.com or +91-767 20 05 050.