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ARAB HEALTH: THINGS YOU SHOULD KNOW BEFORE MEETING LOCAL DISTRIBUTORS

by Arazy Group | Jan 20, 2017

Going to Arab Health? Introducing your medical or in vitro diagnostic (IVD) device in the GCC member states or other countries in the Middle East? Read on to get up to speed with product registration procedures and license information before you meet with local distributors.

Saudi Arabia

What is the name of the competent authority?
Saudi Food and Drug Authority (SFDA)

What is the authority’s review timeframe?
35 working days

How long is a license valid for?
Depends on the compliance route and classification

Who is the license holder?

The manufacturer

Other things to be aware of:
• The registration submission process is done electronically and involves efficient communication with SFDA experts.
• A valid Medical Device Establishment License (MDEL) is required for initiating a Medical Device Marketing Automization (MDMA) process.
• Must have a license in any of the following former GHTF countries: USA, Europe, Canada, Australia or Japan.



United Arab Emirates

What is the name of the competent authority?
The drug control department of the Ministry of Health

What is the authority’s review timeframe?
1 month for classification and up to 24 months for a full registration

How long is a license valid for?
3 years for classification and 5 years for full registration

Who is the license holder?
The manufacturer

Other things to be aware of:
• A classification committee determines whether a device must undergo a full registration process or if a pre-approval may be granted. A pre-approval may be issued with certain restrictions, such as professional use only.
• Most devices are granted a pre-approval importation permit.
• GHTF orientation in both accepted certification and risk classification, although UAE has its own risk-based classification system.
• Hard copy submissions must be made.


Bahrain

What is the name of the competent authority?
The National Health Regulatory Authority (NHRA)

What is the authority’s review timeframe?

6 months

How long is a license valid for?
2 years

Who is the license holder?
Local importer (not necessarily the manufacturer’s official importer)

Other things to be aware of:
• Most documents may be submitted as a soft copy.
• Although there is a set of official documents, NHRA may request additional documents during the review process, such as risk analysis, certificate of analysis and samples provision.
• GHTF orientation when determining compliance route, i.e. the submission process relates to previous approval from a GHTF member.


Oman

What is the name of the competent authority?
Directorate General of Pharmaceutical affairs/Ministry of Health

What is the authority’s review timeframe?
Depends on classification submission

How long is a license valid for?
5 years

Who is the license holder?
Local importer (not necessarily the manufacturer’s official importer)

Other things to be aware of:
• Products are usually allowed to be imported freely.
• A classification committee will determine if a device will be required to undergo a full registration. This is usually the case for higher class devices.
• The registration process involves a pre-qualification of the manufacturing company if the intention is to participate in governmental tenders. A pre-qualification involves in-depth inspection of the manufacturer’s facilities. 


Egypt

What is the name of the competent authority?
Egyptian Drug Authority (EDA) with three other subordinate bodies

What is the authority’s review timeframe?
8 months

How long is a license valid for?
5 years

Who is the license holder?
Local importer (not necessarily the manufacturer’s official importer)

Other things to be aware of:
• The regulatory process is considered complex and bureaucratic. The Ministry of Health regulates medical equipment through several bodies that are responsible for checking various aspects of devices.
• Several committees are involved in medical device registration.
• There are significant differences between the required documents and the review timeframes for low-risk devices and medium- and high-risk devices.
• There are significant differences in the regulatory pathways for sterilized and non-sterilized devices.
• Hard copy submissions through locally registered importers must be made.



Jordan

What is the name of the competent authority?
Jordan Food and Drug Administration (JFDA)

What is the authority’s review timeframe?

3 months

How long is a license valid for?
Depends on compliance route and classification

Who is the license holder?
Local importer (not necessarily the manufacturer’s official importer)

Other things to be aware of:
• Review time is normally very fast for products that are not high-risk or combination devices (devices that include a pharmaceutical compound).
• Involvement of JFDA laboratory/testing facilities may be required in certain cases.
• Hard copy submissions must be made.

You can register your products in all of these countries and more through LICENSALE.COM quickly and independently from your distributor. In many cases, users can process multiple registrations simultaneously, while expediting time-to-market and maximizing revenue . Contact us today to discuss how we can assist you.

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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