The government also grants permission for manufacturing as well as applying for a loan to manufacture medical devices. Any company which intends to manufacture Class A and/or B medical devices needs to obtain a manufacturing license. For companies which want to apply for a loan to manufacture such medical devices can also file an application to receive permission for the grant of loan and further manufacturing.
Class A and B medical devices are considered to be low and low to moderate risk devices and may also include in-vitro diagnostic medical devices.
These licenses are granted for manufacturing medical devices with the intent of sale and distribution.
The application is filed using Form MD-3 for the grant of license to manufacture Class A and Class B medical devices for sale or distribution and the subsequent permission for license to manufacture Class A and Class B medical device is granted in the Form MD-5.
Similarly, the application is filed using form MD-4 for the grant of loan license to manufacture Class A and Class B medical devices for sale or distribution and the permission for loan license to manufacture Class A and Class B medical device is granted in the Form MD-6. Since the application is made for manufacturing Class A and Class B medical devices, it is filed towards the State Licensing Authority of the respective state.
Along with the form, there are certain documents which need to be submitted.
The first document is a cover letter mentioning the subject of the application and any other specific details giving an overview about the application.
For foreign companies applying for the license, the manufacturing license of an Indian agent is a prerequisite.
CliniExperts has a wide array of representatives with pan India access to help our clients file these applications in their respective state(s). Our dedicated team of experts ensure the filing process is quick and simple for the client.
The next document to be submitted is the constitution details of the domestic manufacturer or the authorized agent. The applicant also needs to submit a copy of the test license obtained for the testing and generation of quality control data.
The authorities ensure that the medical device being used for testing does not harm the citizens in any way and thus the applicant is also required to submit a substantial equivalent to the predicate device of the test medical device being imported.
The final document to be attached with the application is the plant master file, while defines the procedure of manufacturing and creation of the medical device in the exporting country.
After filing the application in the prescribed format and with relevant documents attached, the state licensing authority processes and grants the permission using Form MD-6.
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