[IZEN Implant] Document Authentication for Medical Device Registration in Seven Countries

To export medical devices overseas, documents to be submitted to each country's licensing agency must be notarized, apostilled, and confirmed by the consulate. However, medical device export documents are different from general export documents. In addition to standard documents such as LOA (power of attorney), ISO certificate, and CFS (certificate of free sale), there are cases where certification is required for documents that are not normally handled, such as product labels or declarations of conformity.

Izen Implant, a medical device company specializing in implants, exports its products to 7 countries and is processing licensing document certification with Nanum Global.

What was the situation?

Ijen Implant exports medical devices to a total of 7 countries: Russia, China, Indonesia, India, Philippines, Kuwait, and UAE. Documents to be submitted to each country's licensing agency had to be notarized by a law firm, Apostille, and consular authentication.

There are two tricky parts in this case.

First, the amount of documents requested at one time is very large. Since we are processing documents to be submitted to 7 countries simultaneously, we have to accurately classify and process which documents require which certification for each country.

Second, there are cases where documents that are not generally handled are included. Documents such as product labels and declarations of conformity are documents that companies without much experience in accepting Apostille documents may not know how to process or need to check to see if they can be accepted.

How did Nanum Global proceed?

Nanum Global responded quickly to these non-standard documents. We checked in advance whether documents such as product labels and declarations of conformity could be notarized and received Apostille, and clearly guided company managers on the documents they needed to prepare.

The most important thing when processing documents from 7 countries simultaneously is that the authentication method is different for each country. Countries that have signed up to the Apostille Convention (Russia, India, the Philippines, etc.) must use Apostille, while countries that have not signed up (China, Kuwait, UAE, etc.) must use consular authentication. The key is to be able to manage these separately and proceed simultaneously in one place.

Result: 2-3 transactions per month, continued for 2 years

All documents were processed without problems, and export of medical devices to 7 countries is proceeding without a hitch.

Ijen Implant has been requesting document authentication from Nanum Global 2-3 times a month for about 2 years. Even when export countries are added or new types of documents are needed, response is possible from one place, so the value of such a one-stop partner is greater in industries where licensing documents are more complex, such as medical devices.

“One-stop processing of medical device export license documents, notarization, apostille, and consular authentication in 7 countries”