TGA and HC (Health Canada Class 4) in Middle East Countries

I

iceviper

Hi all,
we have a client that needs to register his products in the following countries and has a TGA and HC (health canada) certificates only (HC class 4)

the countries are:
Qatar
Oman
Baharain
Kuwait
Jordan
Lebanon

now, from what I know Jordan require CE or FDA, and Lebanon allows all certificates.

Can someone confirm the information for jordan and lebanon and share knowledge about the other countries?

Thanks in advance.
 

Stijloor

Leader
Super Moderator
Hi all,

We have a client that needs to register their products in the following countries and has a TGA and HC (Health Canada) certificates only (HC class 4)

The countries are:
  • Qatar
  • Oman
  • Baharain
  • Kuwait
  • Jordan
  • Lebanon

Now, from what I know Jordan require CE or FDA, and Lebanon allows all certificates.

Can someone confirm the information for Jordan and Lebanon and share knowledge about the other countries?

Thanks in advance.

A quick bump.

Can someone help?

Thank you very much!

Stijloor.
 

Ajit Basrur

Leader
Admin
Hi all,
we have a client that needs to register his products in the following countries and has a TGA and HC (health canada) certificates only (HC class 4)

the countries are:
Qatar
Oman
Baharain
Kuwait
Jordan
Lebanon

now, from what I know Jordan require CE or FDA, and Lebanon allows all certificates.

Can someone confirm the information for jordan and lebanon and share knowledge about the other countries?

Thanks in advance.

This would be a good start for Jordan - click HERE
 

sreenu927

Quite Involved in Discussions
For Jordan:
1. Proof of approval in the Country of Origin
2. Technical dossier, if requested.

In general, it is not required to submit the technical dossier, instead manufacturers must prove that the MD is approved by the regulatory authority in the product's country of origin.

Import requirements:
1. Import declaration and import license
2. Notarised Certificate of Origin
3. notarised US FDA approval or any other regulatory approval letter and product catalog.

Lebanon:
Submission requirements to Health Engineering Unit, MoPH, Lebanon:
1. application form
2. IFU/User Guide
3. Labels

Apart from the general import requirements such as sales invoice, import license, etc..Certificate of Origin is needed.

Note: Labeling can be written in Arabic or English.

Thanks,
Sreenu
 
I

iceviper

Sreenu - are you sure about Jordan? they accept all kinds of jurisdictions? from what I know, they only accept FDA and CE.
 
I

iceviper

quick update:

Jordan - allows all jurisdictions
Bahrain - allows all jurisdictions
Lebanon - allows all jurisdictions

let's see what we'll have next...
 
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