James Reinstein Country of Origin means the product is approved in the country or region where it is manufactured. Meaning, if you manufacture in Ireland, then CE Mark provides for Country of Origin even if the CORP HQ are in USA. To your question if Mfg in China, SFDA must approve for you to get COO in a country with this rule. Hope this helps.

Robert Lee MS, RAC, CQA Country of Origin means the country of origin for the owner of the medical device design. For example, if the medical device owner is based in US and has manufacturing facility in China, the country of origin is US. C

I don't have a list of countries that require country of origin per se, but there are many that do. They want to know that your device is at least approved or cleared for sale in your own country. If your country is US, you will submit a CFG to the country that wants to know if your device has been approved/cleared by the FDA. After all, why would a country let you sell your device in that country if you don't even have approval to sell it in your own country.

Michael Alper James, Robert, thanks for the answers. Your definitions of country of origin are the exactly the opposite and I've heard them both before which is why I posed the question to the forum. Interestingly enough China, when referring to imported products, defines country of origin similarly to Robert's definition but I've heard (but not confirmed) that certain geographies in Latin America use James's definition. Can anyone confirm for specific geographies they've worked with?

Ee Bin Liew Hi - what are the specific countries involved, then perhaps the group can home in to giving some feedback..

Cheers,
Ee Bin

dear country of origin is necessary in GCC specially saudi Arabia. ... it should match the CE certificate or FDA certificate country of origin

in Egypt . the COO Certificate must be identical to the origin from which the shipment was shipped. and everything is about what you can prove by paper. In other words,if the shipment was shipped from US then you'll need FDA

our company make GAMAM knife for all body. on the. world just our company have for all body GAMMA knife. also. we got. FDA. no need. for raw matiral which. certification. form which country

Michael Alper I'm most interested in Brazil/Latin America (I understand Argentina has a country of origin approval requirement), Eastern Europe (especially Russia), India, Southeast Asian countries and the Middle East. For GCC/Saudi, does it matter where the product is manufactured? I believe FDA and CE allow you to have multiple manufacturing locations.

James Reinstein Robert certainly has more depth in this field bit at prior companies where I worked in multiple geographies, we were US based but manufactured many products in LATAM and Ireland. Country of origin was used to obtain approvals to sell those products (without FDA clearance) in certain countries. I specifically recall selling in KSA and South Korea.

Karen Boyd, ASQ CQA China does not recognize USFDA; must comply with CFDA requirements. Most countries require a cert to foreign government / export cert from US manufacturers - generated via USFDA.

certificate of origin is a kind of documents issued by a specific institutions in the exporting country to prove that the goods exported is made by

There is no standard, hence the differing answers. Each regulatory body has an interpretation of COO, some use FDA or CE, health Canada as a guiding principle. The key to your question is the packaging requirements, where the COO may be defined by the country of manufacture or in certain jurisdictions where the value is added. That is assembled and packaged, not where constituent parts made. As someone who deals globally, it is the bane of my life. One international standard would be so much easier !! Also do not assume that countries in the same region e.g. LatAm make it simple for packaging, what is Ok for Mexico will not necessarily work for Brazil ... Asia, well we are all looking forward to the proposed harmonisation which was tabled for sometime last year but realistically 2020. Hope this provides some explanation to what appears a simple question.

@ Michael Alper, the answer will vary based on the geography/ economy for which the product is intended. For example depending on the geography/ economy the COO could be:
- country of physical manufacturing or
- country of regulatory approval or
- country of shipment or
- country of significant transformation of the product (from raw materials/components)
You will have to check the requirements of the country in question.

For India, if the device falls under the list of regulated devices, it needs regulatory clearance from India. Having a licence in country of origin, fitting both definitions, aids in the process of getting regulatory clearance. The list of regulated devices can be found on CDSCO website.
For non regulated devices, you need a local distributor who can clear customs and get into market. Safety standards for production and safety of Device needs to be supported by appropriate documents.

Michael Alper Thanks all for the replies. Karen, yes in China you must have CFDA first however for imported products you must first have country of origin approval before you go down the CFDA regulatory path otherwise your product will not be approved. Here in China, country of origin is also a bit unclear and I know of cases which it was based on country of manufacture and country of registration.

There are two concepts being discussed here - COO Certificate and COO Approval. CFDA requires COO Approval with the country being where the legal manufacturer resides. Colombia asked for both but they did not have to be of the same country. The COO Approval was of Korea and COO Certificate was of the Philippines.

Dear Michael, i am from Bolivia and FDA is Not suficiente. If you Have Any concerns, don't hesitate to get in contact with me.

Jauru Freitas Hi, here in Brasil it´s call ANVISA ,search the rules in http://portal.anvisa.gov.br/,greats

Sarah Nourse it depends. some countries will accept FDA for a product that is shipped outside of the US. other countries only accept the certificate from the country that the product ships.
example: Ecuador and Mexico only accepts from where it ships however Columbia accepts certificate from FDA or CE.