The Middle East and North Africa (MENA) medical device market is considered a manufacturer’s future high growth market. Saudi Arabia, UAE, Turkey and Israel are considered large markets in terms of size as well as in terms of expenditure capacity. From a Regulatory standpoint, most of the countries have their own systems in place but at various stages of evolution. With regional disparity in terms of accepting devices, the MENA market seems a little complicated for importers and exporters to navigate through, but with the right guidance, this hurdle can easily be overcome.
Freyr, with an extended presence in the MENA region in Dubai, UAE, covers the entire spectrum of Regulatory support services for medical devices required to obtain market authorizations and approvals in this emerging market.
- Product classification and registration services
- Quality Management System (QMS) compliance strategy
- Local representation services
- Gap analysis of the technical documents & quality systems
- Regulatory support for product development documents such as Design History files
- Regulatory support for Technical File compilation
- Regulatory and Market Intelligence support
- Document and labeling translation support
- Health Agency liaising and Support
- Successful submissions for varied class of devices ranging from software to sutures
- Local affiliate access to meet the challenges of authority and language-specific requirements
- Dedicated personnel to provide Medical Devices and IVDs
- In-country or legal representative support with a cost-effective model
- Exclusive delivery center in Dubai, UAE
The Saudi Food and Drug Authority (SFDA) announces (October 5, 2017) a new mandate for low-risk, non-sterile, and non-measuring medical devices which indicates that Medical Device Marketing Authorization (MDMA) registration is not mandatory, but the Medical Devices National Registry (MDNR) listing is required to enter the region. In addition, it is said that an Authorized representative is not needed for these products in Saudi.
Freyr's MENA Regional experts can support you to be compliant with this and other regulatory mandates and guidelines in the region.