Chapter 5 of the medical rules 2017, mentions the regulations related to the import of medical devices in India for sale and distribution. Any authorized agent who already holds a license to manufacture medical devices for sale or distribution can apply for an import license. Moreover, any wholesaler who intends to import medical devices for sale and redistribution shall also apply for an import license.
The licensing process is regulated by the Ministry of Health and Family Welfare in the Central Government. The ministry has an identified online portal through which the application for the import license has to be made. The application is made to the central licensing authority using Form MD-14.
The applicant is also required to submit several other documents along with the application form for verification. First and foremost, the application needs to have a cover letter in proper format and holding proper details for the application. We at CliniExperts help our clients with preparing an immaculate cover letter for filing the application.
Furthermore, the applicant needs to submit a valid wholesale/manufacturer license of Indian agent for medical devices. This is an important prerequisite for filing an application. The applicant also needs to submit a free sale certificate (FSC) with the application. A Free Sale Certificate (FSC) is a document which denotes that the medical devices being imported are freely sold in the open market in the exporting country and are approved for export and trade liberalization.
The supporting documents also includes quality certificates of foreign manufacturers ensuring the device being imported is of good quality. A device master file, which specifies the technical, clinical and safety related information and test data of the medical device being imported. A plant master file must also be included with the application which specifies details about the manufacturing procedure of the medical device.
We help our clients apply for Import License and ensure the process is quick and hassle free. For more information on the same or any query, please feel free to reach us at firstname.lastname@example.org or +91-767 20 05 050.