Country/region specific medical device regulatory requirements

karthika subramaniam

Starting to get Involved
#1
Hello everyone!

Can anyone has presentation/guidance document in getting better understanding of the country/region specific medical device regulatory requirements?

Thank you very much for your help!
 
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karthika subramaniam

Starting to get Involved
#3
Thanks Steve

We are medical device manufacturing firm and we already got CE mark. Now we are trying to register the products in various markets in South East Asian countries (like Brunei, Myanmar, Cambodia, East Timor, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand, Vietnam) and also African countries (like Algeria, Angola, Benin, Botswana, Burkina, Burundi, etc.)

Can you please tell us that should we need to do the registration process for each country? Or with CE we can sell our products in South East Asia and Africa Or apart from CE should we need to get any other product certification?

If we require doing registration for each country and also if it calls for additional certification apart from CE, can you please advise us how to do that and what are the certification required in addition to CE?

Can you please help? Thanks so much....
 

Ronen E

Problem Solver
Staff member
Moderator
#4
CE marking is relevant for some countries, but not for all.

On the top left hand area of this page you have a search box. This is a Google powered search on Elsmar. Search by country name (one by one) and you'll find a lot of information.

Hurry up, you have Elsmar up and running until the end of 30.6.15. After that it goes offline, probably forever. Whatever relevant information you find, download and save it to your own files, for later reference.

Several of the Asian countries you listed fall under the ASEAN organisation. Search for the AMDD - this will apply to all ASEAN countries in the future.
 
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