Navigating the regulatory landscape for medical devices in India can be a complex process, requiring manufacturers, importers, and other stakeholders to obtain various licenses and approvals from the relevant authorities.
These “MD Licenses” are crucial for ensuring the safety, efficacy, and quality of medical devices, as well as promoting compliance with the Medical Devices Rules, 2017, and other applicable regulations. Whether it’s a license to manufacture, import, conduct clinical investigations, or distribute medical devices, these licenses play a vital role in safeguarding public health and fostering a robust and trustworthy medical device industry in the country.
| Sr. No. | Application Forms | Approval Forms |
|---|---|---|
| 1 | MD 1 – Application for grant of Certificate of Registration of a Notified Body | MD 2 – Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017 |
| 2 | MD 3 – Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device | MD 5 – Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device |
| 3 | MD 4 – Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device | MD 6 – Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
| 4 | MD 7 – Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D | MD 9 – Licence to Manufacture for Sale or for Distribution of Class C or Class D |
| 5 | MD 8 – Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D | MD 10 – Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device |
| 6 | MD 14 – Application for issue of import license to import medical devices In Class C or D (In vitro) | MD 15- Licence to Import Medical Device In Class C or D (other than in vitro) |
| 7 | MD 16 – Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training | MD 17 – Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| 8 | MD 18 – Application for license to import investigational medical devices for the purposes of a government hospital or statutory medical institution for the treatment of patients | MD 19 – Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients |
| 9 | MD 20 – Application for permission to import a small quantity of medical devices for personal use | MD 21 – Permission to import of small quantity of medical devices for personal use |
| 10 | MD 22 – Application for Grant of permission to conduct a clinical investigation of an investigational medical device | Form 23 – Permission to conduct Clinical Investigation |
| 11 | MD 24 – Application for grant of permission to conduct a clinical performance evaluation of new in vitro diagnostic medical device | MD 25 – Permission to conduct a clinical performance evaluation of a new in vitro diagnostic medical device |
| 12 | MD 26 – Application for grant of permission to import/manufacture for sale or for distribution of medical device which does not have predicate medical device | MD 27 – Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device |
| 13 | MD 28 – Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device | MD 29 – Permission to Import or Manufacture New In Vitro Diagnostic Medical Device |
| 14 | MD 39 – Application for grant of registration to Medical Device Testing Laboratory for carrying out Test or Evaluation of a medical device on behalf of a manufacturer | MD 40 – Certificate of registration to Medical Device Testing Laboratory for carrying out Test or Evaluation of a medical device on behalf of the manufacturer |
| 15 | MD 41 – APPLICATION FOR GRANT OF REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE OR DISTRIBUTE A MEDICAL DEVICE | MD 42 – PERMISSION TO IMPORT, STOCK, OR SELL MEDICAL DEVICES |
Looking to import medical devices into India? Reach out to our experts to ensure compliance with all regulatory requirements and streamline the import process. or mail us @contact@nkgabc.com
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