Last Updated on March 18, 2022
To obtain Establishment License to import medical devices
In order to register an imported medical device in the country, the importer must first obtain an Establishment License to import medical devices from Medical Devices Division of DRAP.The applicant must submit online application on the “MDMC Online System For Establishment of License” and may take assistance from “User Guide of MDMC Online System For Establishment of License” available on this website. Submission of online application is followed by the submission of the hardcopy of the application to Medical Devices Division, DRAP on Form-2 available on website. To facilitate the applicant in understanding the Form the “Checklist For Grant Or Renewal Of An Establishment License To Import Medical Devices” is also available on website to facilitate the importer.
Once the complete application is received in DRAP, the storage premises may be visited by the panel constituted by DRAP. The document “Guidelines on Good Distribution Practices for Medical Devices” may be referred to understand the regulatory requirements from an importer of medical devices. The scope of inspection may be understood by viewing the “Checklist For Good Storage Practices For Medical Devices” which to be filled by the panel of inspectors visiting the premises.
The Competent Authority to grant License is Medical Device Board (MDB).