Unfortunately Anon, you are trying to greatly simplify an amazingly complex topic. Generally, companies and 3rd parties spend extensive resources compiling the list of "requirements" in each country, and thus tend to treat them as proprietary. There are some parties (Tarius, Emergo) that have pretty robust databases, but, rightly so, they charge for ongoing access to this. Even these have some challenges, as the regulations are always changing somewhere, and in fact in some countries change amazingly fast (look how often Grace and Ames post updates on China in this forum). Thus, even with best intent, these resources are sometimes out of data. In addition, many countries don't post their regulations in any language beyond the local one, so if someone wants an English (or Spanish etc) version, they have to get someone to translate from those local languages to the desired language - which also costs time and money.
As to "who takes the CE Mark" and "who takes 510(k)s, the answer tends to be "it depends." First, what do you mean by "takes or requires" - as in who are the EU countries that require CE - that list is pretty straight forward. It gets far more complicated as soon as you go outside the EU - many countries take it as part of, or the basis of, their requirements, but there are still local items to complete. Additionally, whether they "take" a CE Mark or a FDA clearance/approval may depend on where you are located - some countries require approval in your "country of origin" before they will allow registration in their country. Further, in some markets, the type of product matters - lower risk products may have simpler requirements than riskier ones, or electro-medical equipment may require more substantive registration than a disposable devie where they may accept an out of market registration.
Sorry to not be more help, but this is really complex at times, and honestly the best way to find out what is required in a market is to contact a local, or relatively local, expert who has dealt with your types of products. Sometimes good distributors have these available, sometimes you are better off getting independent regulatory resources. As you learn, you can start compiling your own "manual" as to what has been required, but be sure to keep up with changes.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 11-Mar-2020 11:11
From: Anonymous Member
Subject: CE Mark and 510(k) clearance
This message was posted by a user wishing to remain anonymous
Hello,
Can someone forward white paper or document that covers global registration requirements for every country?
Also, what countries accept/require 510(k) approvals and what countries require/accept a CE Mark?
Thanks!