Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,
We have a Medical device that we would like to sell in UAE. As per my understanding, we need to first apply for a Classification certificate via the MoH's e-services portal. This can be done by anyone including any individual based outside UAE (the person should upload a copy of their Passport as one of the document). The MoH determines in the classification certificate if registration of product is required or it is exempt from registration. If registration is required this has to be performed through a local representative or agent or MoH registered business in UAE. 

Can anyone confirm if my understanding of the process is correct? and
If anyone, outside UAE, have applied for a Classification certificate and how was the experience with the process i.e. was it easy or difficult, response from MoH etc.

Thanks

Hello Anon,

Your assessment is my understanding as well.  If the device is required to be registered, the fees for acquiring a CFG, Power of Attorney, and subsequent legalization fees are not trivial.   The UAE embassy legalization fees are the highest I have encountered.  Also, the documentation required for registration must be based on EU, US, or Japan market clearance (EU is the easier route in most cases).

------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 10-Feb-2021 16:07
From: Anonymous Member
Subject: UAE - Medical Device Classification Certificate

This message was posted by a user wishing to remain anonymous

Hi All,
We have a Medical device that we would like to sell in UAE. As per my understanding, we need to first apply for a Classification certificate via the MoH's e-services portal. This can be done by anyone including any individual based outside UAE (the person should upload a copy of their Passport as one of the document). The MoH determines in the classification certificate if registration of product is required or it is exempt from registration. If registration is required this has to be performed through a local representative or agent or MoH registered business in UAE.

Can anyone confirm if my understanding of the process is correct? and
If anyone, outside UAE, have applied for a Classification certificate and how was the experience with the process i.e. was it easy or difficult, response from MoH etc.

Thanks

Hello,

Your understanding is correct. Currently only pharmaceutical or biological products classified as pharma like products are subject to product registrations.

------------------------------
Youmna Abboud
beirut
Lebanon
------------------------------

Original Message:
Sent: 10-Feb-2021 16:07
From: Anonymous Member
Subject: UAE - Medical Device Classification Certificate

This message was posted by a user wishing to remain anonymous

Hi All,
We have a Medical device that we would like to sell in UAE. As per my understanding, we need to first apply for a Classification certificate via the MoH's e-services portal. This can be done by anyone including any individual based outside UAE (the person should upload a copy of their Passport as one of the document). The MoH determines in the classification certificate if registration of product is required or it is exempt from registration. If registration is required this has to be performed through a local representative or agent or MoH registered business in UAE.

Can anyone confirm if my understanding of the process is correct? and
If anyone, outside UAE, have applied for a Classification certificate and how was the experience with the process i.e. was it easy or difficult, response from MoH etc.

Thanks

Hi All. 

Could anyone share the fees for applying for a registration certificate? I have not been able to find anything concrete and would like to understand before I go ahead with this.

Thanks

James

------------------------------
James
Head of QARA
UK
------------------------------

Original Message:
Sent: 10-Feb-2021 16:07
From: Anonymous Member
Subject: UAE - Medical Device Classification Certificate

This message was posted by a user wishing to remain anonymous

Hi All,
We have a Medical device that we would like to sell in UAE. As per my understanding, we need to first apply for a Classification certificate via the MoH's e-services portal. This can be done by anyone including any individual based outside UAE (the person should upload a copy of their Passport as one of the document). The MoH determines in the classification certificate if registration of product is required or it is exempt from registration. If registration is required this has to be performed through a local representative or agent or MoH registered business in UAE.

Can anyone confirm if my understanding of the process is correct? and
If anyone, outside UAE, have applied for a Classification certificate and how was the experience with the process i.e. was it easy or difficult, response from MoH etc.

Thanks

Hi James,

Please see attached for your reference: 

1. Official Fee to obtain classification certificate: AED 500
2. Official Fee to register the manufacturer: AED 10,000 (excluding application fee AED 100) - all manufacturer should register their manufacturing facility as part of device registration process. Manufacturers of class III or IV devices may subject to an onsite audit and inspection.
3. Official Fee to obtain registration certificate: AED 5000 (excluding application fee AED 100)

Hope it helps!

------------------------------
Fajar Dumadi
Regulatory Intelligence Officer
Vancouver BC
Canada
------------------------------

Original Message:
Sent: 07-Apr-2021 04:01
From: James Davis
Subject: UAE - Medical Device Classification Certificate

Hi All.

Could anyone share the fees for applying for a registration certificate? I have not been able to find anything concrete and would like to understand before I go ahead with this.

Thanks

James

------------------------------
James
Head of QARA
UK

Original Message:
Sent: 10-Feb-2021 16:07
From: Anonymous Member
Subject: UAE - Medical Device Classification Certificate

This message was posted by a user wishing to remain anonymous

Hi All,
We have a Medical device that we would like to sell in UAE. As per my understanding, we need to first apply for a Classification certificate via the MoH's e-services portal. This can be done by anyone including any individual based outside UAE (the person should upload a copy of their Passport as one of the document). The MoH determines in the classification certificate if registration of product is required or it is exempt from registration. If registration is required this has to be performed through a local representative or agent or MoH registered business in UAE.

Can anyone confirm if my understanding of the process is correct? and
If anyone, outside UAE, have applied for a Classification certificate and how was the experience with the process i.e. was it easy or difficult, response from MoH etc.

Thanks

Hi Anon,

Yes, your understanding is correct!
The process to obtain classification certificate is pretty simple and straight forward, it takes around 2 weeks. Documents required are:

1. Product catalogue/ brochure
2. Product photograph
3. CFS/CE Certificate
4. Registration and marketing status in other countries - if applicable
5. Leaflet/product information in English/Arabic
6. Packaging Artwork
7. MSDS -  if applicable 

Official Fee: AED 500

------------------------------
Fajar Dumadi
Regulatory Intelligence Officer
Vancouver BC
Canada
------------------------------

Original Message:
Sent: 10-Feb-2021 16:07
From: Anonymous Member
Subject: UAE - Medical Device Classification Certificate

This message was posted by a user wishing to remain anonymous

Hi All,
We have a Medical device that we would like to sell in UAE. As per my understanding, we need to first apply for a Classification certificate via the MoH's e-services portal. This can be done by anyone including any individual based outside UAE (the person should upload a copy of their Passport as one of the document). The MoH determines in the classification certificate if registration of product is required or it is exempt from registration. If registration is required this has to be performed through a local representative or agent or MoH registered business in UAE.

Can anyone confirm if my understanding of the process is correct? and
If anyone, outside UAE, have applied for a Classification certificate and how was the experience with the process i.e. was it easy or difficult, response from MoH etc.

Thanks