Regulations for importing an IVD diagnostic test in India

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L

Linda Liu

#13
Dear Sreenu,

If our products all are non-notified products, then can we sale them directly in India without an agent, infact, import license is still needed, so are there any special requirements about import license?

Thank you very much.

Linda
 

sreenu927

Quite Involved in Discussions
#14
Hi Linda,

In the case that ALL your products fall under "Non-Notified" IVDs:

1. If you are a local manufacturer in India, you must have a manufacturing license.
2. If you are a foreign manufacturer, then you must have your agent with wholesalers license.

Process to obtain Import Permit (Form 10) is obtained from the below link from CDSCO-India:
http://cdsco.nic.in/draft_guidance.htm

Hope this helps!

Regards,
Sreenu
 
L

Linda Liu

#15
Dear Screenu,

Thank you very much.
I have read the Form 10 list, "Duly notarized and valid copy of Free Sale certificate or Certificate to Foreign Government issued by National Regulatory Authority from country of origin mentioning name and address of both legal and actual manufacturer" is one of which required to get the import license, so what's the meanning of this, should we get free sale certificate of which country at first?[FONT=&quot]
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And should all the document should be provide to get the import license?
Looking forward to your reply, thank you very much.

Linda
 

sreenu927

Quite Involved in Discussions
#16
Hi Linda - Obtain FSC from the Country of Origin. If the COO is the contract manufacturer and/or not freely sold, then you can obtain the FSC from the legal manufacturer's country or where freely sold or registered.

See item 6 in Form 10 as below:
6. Duly Apostilled/notarized/attested from the Indian embassy (country of origin) valid copy of following:-
Free sale certificate/ Exportability certificate in respect of the proposed Diagnostic kits/Reagents issued by National Regulatory Authority of the country of origin clearly stating that the proposed Kits/Reagents are freely sold in the country of origin.
or
If the proposed products are not sold freely in the country of origin ,Free Sale Certificate/ Import licenses from National Regulatory Authority of other countries where the proposed products are being freely sold.


Regards,
Sreenu
 

bio_subbu

Super Moderator
#17
Dear Sreenu,

If our products all are non-notified products, then can we sale them directly in India without an agent, infact, import license is still needed, so are there any special requirements about import license?

Thank you very much.

Linda
Hi Linda

Import license is needed to the distributor/importer who will going to import the non-notified medical devices (IVD Kits). Please be noted, you can apply import license application for non-notified medical devices (IVD Kits) directly if the application is not for the product used for ?Malaria, Dengue, Typhoid, Syphilis, Cancer Markers, Chikungunya, Tuberculosis?. Normally, it will take 30 to 40 days to get the approval from DCGI (Drug Controller General of India) office.

If the application is for import license of the aforesaid products, you need to submit an Evaluation Report of the three batches. The evaluation test report should be from NABL accredited laboratories. Once you have the report then only you can apply for import license of these products.

To get the Evaluation Report, you may want to apply for test license to import the quantity for evaluation. The whole process till the approval of Import License will take 3 to 5 months of time.

Refer attached, list of documents required for Import license for non-notified medical devices (IVD Kits) in India.
 

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