Where to find UAE medical device registration regulation and guidelines

Elsmar Forum Sponsor
H

Hobbes_01

#2
Hi,

In my understanding, medical device regulations are not yet in place in UAE, but regulations and registration requirements are drafted now. Which might explain why there is no easily accessible website (I cannot find it either).

Normally, CE marking and/or 510(k) clearance is sufficient for customs clearance, but a CFG / FSC might be requested.

Typically, I would suggest to contact your local distributor for the import requirements and actual status of the development of local registration requirements.

Language is arabic, while English is acceptable for professional use.

Good luck!
 

Ajit Basrur

Staff member
Admin
#3
Could anyone tell me the UAE official website for reviewing the medical device registration regulation and guideline?

I only found the UAE MOH website: http://www.moh.gov.ae/en/Pages/default.aspx

But I could not find the regulation and guideline from this website.

Thanks in advance!
Refer an existing post from my friend, bio_subbu - http://elsmar.com/Forums/showpost.php?p=382244&postcount=5

This post is contained in a thread where you could find additional information - http://elsmar.com/Forums/showthread.php?t=41889
 

Mark Meer

Trusted Information Resource
#4
Reviving thread, in case anyone can direct to some resources regarding the current UAE medical device regulations.

As mentioned by the OP of this thread, the UAE MoH website does not appear to link to any regulations (unless they are under "Public Health Policies" - content that is in Arabic only).

Ajit links to a previous post by bio_subbu, which contains several helpful attachments, but given that his post was over 8 years ago, I'm concerned that they may no longer be relevant/applicable.

Can anyone knowledgeable regarding the United Arab Emirates medical device market kindly advise:
  • Are the guidances attached in bio_subbu's post still applicable?
  • If not, is there anywhere where (official) English guidance can be publicly accessed?
 
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