Regulatory Open Forum

The FDA Guidance on Import for Export notes:

There are two ways of demonstrating that a product to be exported is not in conflict with the laws of the importing country. Either:

a)       a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or

b)      a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country. If a certification is used, the certification must be in English and include a statement

For countries with no applicable medical device regulation, item a) is hard to get. 

 

What is your experience with the item b) level of documentation to support the certification and FDA compliance review of certification?

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Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
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The most practical way to ensure that medical devices do not conflict with the regulations of the potential importing country is to register the device.  The majority of countries have evolved registration regulations that are similar but less cumbersome to the US pre-marketed notification regs or informally harmonized with the Medical Device Directive with acceptance of ISO standards.

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Ponzelle Royster RAC
Duluth GA
United States
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Original Message:
Sent: 03-12-2013 10:57
From: Gary Syring
Subject: Export under 801(e): ...not conflict with the laws of the importing country

The FDA Guidance on Import for Export notes:

There are two ways of demonstrating that a product to be exported is not in conflict with the laws of the importing country. Either:

a)       a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or

b)      a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country. If a certification is used, the certification must be in English and include a statement

For countries with no applicable medical device regulation, item a) is hard to get. 

 

What is your experience with the item b) level of documentation to support the certification and FDA compliance review of certification?

-------------------------------------------
Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
-------------------------------------------