The Drug Control Administration of Vengalarao Nagar, Hyderabad has issued a list of documents to be submitted for Grant of Registration Certificate in Form MD-42 to Sell, Stock, Exhibit or Offer for Sale or Distribute a Medical Device including in-vitro diagnostic Medical Device.
This list will be applicable to those persons who don’t hold license in Form 20, 21, 20B and 21B of
Drugs and Cosmetics Rules, 1945.
Applicants should first register themselves on the Online System for Medical Devices Portal.
The present notification details a list of 10 documents that must be submitted to obtain the certificate of registration. These include:
- Covering Letter
- application in Form MD-41
- Copy of the challan for fees
- Self-certification of compliance to Good Distribution Compliance
- Rent /lease document/ Land Lords Declaration with tax receipts
- Details of competent technical staff (CTS)
- Bio Medical Waste and CTS Affidavit with notary