Indian Medical Device Registration Requirements

[xgg810116]

1. In IVDD FAQ, the 36 point shows:
Whether devices imported under valid import license can stock in any other wholesale license premises other than stated in the Import License? Ans: Yes

Does it mean that the devices with valid import license could be imported by other importers with wholesale license, which are not stated in the Import License?

2. How to get the wholesale license?

3. 17 Notified Medical Devices need to get Manufacturing License, before could manufacture in India. Do other Medical Devices need the Manufacturing License too?

I found the draft Schedule M IV for GMP and requirements of Premises for In-Vitro Diagnostic Reagents or Kit. Has this draft been effective?

4 Notified Medical Devices are regulated by concerned State Drug Licensing Authority, and other 13 Notified Medical Devices are regulated by Central Licence Approving Authority.
What?s the difference between them? Are the Manufacturing Licenses been issued in the same form format?

Could anyone reply? Thanks in advance!

 

[Stijloor]

A Quick Bump!

Can someone respond?

Thank you very much!!

 

[sreenu927]

1. No. It means the importer who has license to import the products must import and can store anywhere who has the wholesalers license.

2. Wholesaler license: Form 20B and 21B (I guess). You need to have a competent person to represent your company or branch in India and can obtain wholesalers license.

3. Non-Notified Medical devices produced in foreign countries do not require manufacturing license. They just need import permit for each product. No registration is required.

Although the guidance docs are in draft stage, that is the Authority's way of thinking and Industry started considering the same and following.

4. Personally, I have not seen any certificates from State Licensing Authorities. However, it would be same; the only thing is decentralisation of work or powers, make State Authorities to issue the certificates. IMO, all manufacturer licenses, either issued by State or Central Authority would be in same format.

Regards,
Sreenu

 

[xgg810116]

Hi sreenu, thank you very much!

For NIB evaluation test, the test license should be afforded to NIB, right? But I only found one Guidance Document on Grant of Licence in Form 11 (test licence), which is only on drugs for human use which undergo systemic circulation, but not applicable for import of Diagnostics kits, Medical Devices.

Do Diagnostics kits, Medical Devices NOT need the Test Licence for NIB evaluation? If need, is there any guidance?

Thanks again!

 

[sreenu927]

Notified Medical devices included IVDs and a few Non-notified diagnostic kits like Chikunguniya, Malaria, TB, etc..require Performance Evaluation Test to be performed at NIB labs.
You can check the IVD FAQ Guidance as attached.

You have to apply for a Test License to import small quantity of products to conduct performance evaluation test, not NIBs.

Regards,
Sreenu

 

[xgg810116]

Hi sreenu, thanks again!

Where could I get the guidance for grant Licence in Form 11 (test licence) for Notified medical device and IVDD ? I only found one guidance on drugs for human use which undergo systemic circulation, but not applicable for import of Diagnostics kits, Medical Devices.

 

[bio_subbu]

Hi sreenu, thanks again!

Where could I get the guidance for grant Licence in Form 11 (test licence) for Notified medical device and IVDD ? I only found one guidance on drugs for human use which undergo systemic circulation, but not applicable for import of Diagnostics kits, Medical Devices.

I don't think there is a specific guidance document for Grant Licence in Form-11 (test Licence) for Notified medical device and IVDD. However, you can get the details from the attached Pre-screening checklist", please refer the page 6 of 25 for Checklist for Pre Screening of Applications for Grant of Test License in Form-11 for small quantity of medical devices & page 22 of 25 for Checklist for Pre Screening of Applications for Grant of Test License in Form-11 for in-vitro diagnostic Kits/reagents.

Also, you can download the checklist directly from CDSCO website