License For Manufacturing Medical Devices

Any individual or company involved in manufacturing the medical devices can commercialise or distribute the products by applying through the State Licensing Authority. The application process includes applying for a grant, loan or license to sell or distribute. The application can be made in the online portal of the Ministry of Health and Family Welfare as per the Medical Devices Rules, 2016. The category of medical devices includes Class A, Class B, Class C and Class D.

Process of Applying for Class A and Class B License with Grant and Loan

Step 1: The applicant should register with the Ministry of Health and Family Welfare Step 2: To apply for a licence, the applicant shall upload the Form MD-3 with all relevant details. Step 3: To apply for loan licence, the applicant shall upload the Form MD-4 with all the relevant details. The form should be uploaded with the fee, as mentioned in the Second Schedule of Part II. Step 4: All the relevant information must be uploaded as per sub-rule(1). Step 5: After uploading the relevant documents and forms, the applicant shall submit the undertaking as required by the Quality Management System. Step 6: The State Licensing Authority shall probe regarding the application applied Step 7: After probing, the State Licensing Authority shall provide the manufacturing licence in Form MD-5 Step 8: For loan licence, the State Licensing Authority shall provide it through Form MD-6 Step 9: Upon rejection of the licence, the State Licensing Authority shall notify the applicant within 45 days in a written format. For documentation and registering companies, click here

Process of Applying for Class A and Class B License with Grant and Loan

Step 1: The applicant should register with the Ministry of Health and Family Welfare Step 2: To apply for manufacturing licence or loan licence for Class C, the applicant shall upload the Form MD-7 with all the relevant documents Step 3: To apply for manufacturing licence or loan licence for Class D, the applicant shall upload the Form MD-8 with all the relevant documents Step 4: The forms should be uploaded with the fee, as mentioned in the Second Schedule of Part II. Step 5: All the relevant information must be uploaded as per sub-rule(1). Step 6: After submitting all the documents, the application will be probed by the Central Licencing Authority with 45 days. Step 7: Upon approval of the licence, the Central Licencing Authority shall provide the licences through Form MD-9 and Form MD-10. Step 8: Upon rejection of the application, the applicant shall file again to the Central Licencing Authority with 45 days with all the relevant documents.

Conditions for Manufacturing licence or Loan licence

After receiving a grant of licence or loan licence in Form MD-5, Form MD-6, Form MD-9 or MD-10, the licence holder should follow the following conditions:
The licence should be produced when requested by the Medical Device Officer or any other senior officials from the Central Licensing Authority or State Licensing Authority
In case of any suspected unexpected serious adverse event, the licence holder should inform the State Licensing Authority or the Central Licensing Authority and inform about the action taken within 15 days
The licence holder should request for approval before making any major change. The request should be applied, as mentioned in the Sixth Schedule. After approval, the licence holder shall detail the information within 45 days to the State Licensing Authority or Central Licensing Authority
As per sub-rule (3) of rule 83, the licence holder should perform tests in the laboratory before releasing the products. All the test documents should be submitted in the Central Licensing Authority or State Licensing Authority
All the audit must be documented in Form MD-11
All the test samples must be preserved for a period of 180 days after expiry
The licence holder should maintain records of manufacturing and sales and should be produced when required by Medical Officer
If the medical device manufacturer stopped manufacturing the devices for more than 30 days, the relevant information should be informed to the Central Licensing Authority or the State Licensing Authority

Validity of the Licence

The validity of the licence received in Form MD-5, Form MD-6, Form MD-9 or MD-10 is for a period of 5 years. In the case of the licence being suspended or cancelled, the applicant shall apply within 45 days from the date of the action.

Documents Required

A letter detailing the purpose of the application
Letter authorised from by an India Agent Firm along with details of the company
Forms filled as per the Drugs and Cosmetics Rules
Copy of memorandum of association, partnership deed or article of association
Complete details of the technical staff with the degree certificates
Formalities covered as per Annexure V

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Frequently Asked Questions

Common questions about Licence for Manufacturing Medical Devices.

The process involves registering with the Ministry of Health and Family Welfare, uploading Form MD-3 or MD-4 along with the prescribed fee, providing necessary documents and undertakings, and obtaining the license (Form MD-5 or MD-6) from the State Licensing Authority after their assessment.

To apply for a license to manufacture Class C or Class D medical devices, you need to upload Form MD-7 or MD-8, respectively, along with the prescribed fee and relevant documents. The application will be assessed by the Central Licensing Authority, which will grant the license (Form MD-9 or MD-10) upon approval.

Among other conditions, the license holder must produce the license upon request, report any adverse events, seek approval for major changes, perform necessary tests, maintain records, inform authorities about manufacturing stoppages, and comply with the prescribed rules and regulations.

A license granted in the form of MD-5, MD-6, MD-9, or MD-10 is valid for a period of 5 years from the date of issuance.

The required documents include a purpose letter, authorization letter from an Indian agent, filled forms as per the Drugs and Cosmetics Rules, documents related to the company's registration, details of technical staff with degree certificates, and other formalities mentioned in Annexure V.

Yes, individuals can apply for a license to manufacture medical devices by following the prescribed process and submitting the required documents to the State Licensing Authority or Central Licensing Authority, as applicable.

A manufacturing license allows the holder to manufacture and commercialize medical devices, while a loan license is typically granted for the purpose of testing, evaluation, or research and development of medical devices.

The State Licensing Authority or Central Licensing Authority, as applicable, has a timeline of 45 days to assess the application and provide a decision on granting or rejecting the license.

Yes, a prescribed fee mentioned in the Second Schedule of Part II of the Medical Devices Rules, 2016 must be paid along with the application forms (MD-3, MD-4, MD-7, or MD-8).

If the application is rejected, the licensing authority (State or Central) will notify the applicant in writing within 45 days. The applicant can then file a fresh application with all the relevant documents and prescribed fees.