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Iraq Medical Device registration

#1
Hello, :) I would like to ask a few questions about medical device/pharmaceutical product registration in Iraq.

Our company manufacturers hyaluronic acid (HA) fillers in Korea.
Our products are divided into two types: HA Filler with Lidocaine and HA filler without Lidocaine.

Anyone can answer the questions below?

Q1. Our partner says that HA fillers containing lidocaine are classified as pharmaceuticals in Iraq. Is this information correct?
1.1 If yes, I would appreciate if you guys could give me a list of documents required for registration in Iraq.
1.2 If yes, filler products are classified as medical devices in Korea/Europe, so the GMP certificate (or ISO13485) is also for medical devices. In this case, is it possible to submit the medical device GMP certificate as a registration document?
1.2.1 If Iraq MoH does not accept medical device GMP certificate, do we have to undergo a pharmaceutical GMP inspection form Iraq MoH?

Q2. I know that HA Fillers without lidocaine are classified as medical devices. Is CE certificate required to register in Iraq? Also, I would appreciate if you guys could give me a list of documents required for registration.

Q3.I understand that in order to register medical devices/pharmaceuticals in Iraq, Company Registration is required first. We plan to advance not only filler products, which are medical devices, but also botulinum toxin products (pharmaceutical). In this case, is each company registration required? Also, it would be appreciated if you guys could provide a list of required documents.


Thank you
 
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