Medical Device Expansion into the Middle East and North Africa

This is the second short article in a 3-part series authored by Daniel English, Regulatory Affairs Consultant at IMed Consultancy.  This article follows on from Part 1 and considers medical device opportunities and market expansion into the international marketplace.  Here, Daniel looks at requirements for medical device entry into the Middle East and North Africa.

This short article will provide an overview of those classification systems, requirements and regulatory pathways which often have commonality with other countries within the same region.

Medical Devices in the Middle East and North Africa

Market Data Forecast states that the medical Device Market in the MENA region is valued at over 43 million (USD) 2022 and projected to reach over 73 million (USD) by 2027. For this reason, the region has been key growth target area for medical device manufacturers. The region contains many different systems, requirements and approval processes. For a little insight into one of these markets we can look at the largest economy and medical device market in the MENA region; Saudi Arabia (Saudi) a market which generally seen a lucrative prospect for many medical device manufacturers and distributors.

Placing Medical Devices on the Saudi Arabian Market

Medical devices in Saudi Arabia are regulated by the Saudi Food and Drug Authority (SFDA). Saudi medical device regulations have recently been significantly updated and as of August 2021 with the new law updating medical device classifications and requirements for devices seeking marketing authorization (MDMA) for devices considered high-risk, while the less demanding pathway for low class medical devices currently remains in place.

Saudi Risk classification for medical devices range from Class A (low risk) to Class D (High). Class A is split into four classes covering Class A sterile, Measuring and Reusable surgical instruments .You must identify your devices classification based on the SFDA’s latest guidance. Classification generally matches the EU MDR with Class A being EU Class I for example.

If you have a device considered Class A only, low risk (except IVDs, sterile, having measuring function, reusable surgical instruments, and novel) then good commercial opportunities may exist and given the pace of changes from the SFDA, now might be a good time if you’re a manufacturer of a low-risk device and considering entering the Saudi market. 

Technical File Assessment Submissions in Saudi Arabia

As of August 2021, any new medium to high-risk medical device must be submitted to the SFDA via the newly introduced Technical File Assessment (TFA) the requirement for which is technical documentation closely matching that already required EU MDR technical documentation. Manufacturers, distributors, importers and Authorised Representatives must be certified to the international Quality Management System standard, ISO 13485:2016. Medical devices should also comply with the Essential Principles of Safety and Performance specified in Annex 1 and 2 of the official SFDA guidance.

Foreign manufacturers must appoint an Authorized representative who will manage device registration and the compliance with the latest regulations. This person can either be your distributors or, as is highly recommend, a separate in market Regulatory agency. Using an established Saudi Regulatory agency can help to significantly ease the process and support your market authorisations.

Things to consider when placing a medical device on the Saudi market

• The current low-risk device market authorisation procedure via listing on the Medical Device National Registry (MDNR) is expected to be revised soon.
• Medical devices can be bundled/grouped within one application under either Family, System or Procedure pack. (The MDS-REQ1 guidance details the bundling criteria).

In case you missed the first article, you can find it here.

Please look out for Part 3 of this global expansion review where Daniel will look at the Latin American region.