SFDA Medical Device Registration

Between 2019 and 2022, the Saudi Food and Drug Authority (SFDA) had extensively updated the medical device regulations in Saudi Arabia. In particular, the medical device marketing authorization (MDMA) application. It evolved to cope with the updates in the international standards (EU MDR). The continuous development and reengineering of the registration procedures has increased the complexity of the SFDA registration process.

For example, in September 2022, the SFDA officially cancelled the low risk medical devices registration procedure, known as Medical Device National Registry (MDNR). This simple application with easy fees isn’t available anymore. All devices now, from low to high risk classes, must be submitted through MDMA with a full technical file. Moreover, legal manufacturers of low risk devices are also required to appoint a Saudi authorized representatives (AR).

We will clarify in the below article the significant updates in the abovementioned procedures and detail the SFDA medical device registration requirements that both multinational and local companies may encounter. We will also define the differences in the medical device classification with the EU regulations.

Medical devices regulations in Saudi

The SFDA used to recognize approvals in the other GHTF countries, such as the European Union EU, United States, Canada, Australia, and Japan, simplifying the authorization process in Saudi Arabia. However, SFDA cancelled the GHTF route by the end of 2021.

Starting Jan 2022, all MDMA applications must undergo the Technical File Assessment (TFA) procedure. This is resulted from SFDA revision of numerous requirements influenced by the MDR and IVDR.

Therefore, the registration requirements for the MDMA application evolved to be substantially rigorous with much more conditions such as updated clinical evaluation reports CER, biocompatibility reports, and the need to conduct a post-market clinical follow-up PMCF study in Saudi Arabia.

On the other hand, the listing procedure (registration ) of low-risk medical devices is no longer available since Sept 2022. All low-risk devices will be required to re-register through the MDMA route, which requires a TFA application. In conclusion, there is no longer simple registration procedure available for low risk medical devices.

Medical devices classification

Generally, the SFDA medical device classification will follow the same Class in the reference country. For example, the SFDA will match the classification in the CE certificate. However, we have seen very few cases where SFDA did not follow the same. For example, a product is considered a low-risk medical device in its home country but a non-medical device in Saudi, and vice-versa.

SFDA medical device classification is either Class A, B, C, or D. This is according to their risk class. The Class is necessary to determine the registration procedure and its requirements, as discussed in the next part.

The SFDA MDS-G5 document details the classification rules (similar to the European MDR classification).

SFDA Medical Device Classification	Risk Class	MDR Classification Rule
A	Low	I
A – Sterile	Low-medium	Is
A – Measuring function	Low-medium	Im
A – Reusable surgical instruments	Low-medium	Ir
B	Low-medium	IIa
C	Medium-high	IIb
D	High	III

In the SFDA (MDS-G42) guideline, we can find more clarification of the SFDA classification rules. Concerning in vitro diagnostic, the SFDA is also adopting the European medical device regulation IVDR:

SFDA Medical Device Classification	Risk Class	Classification Rule
A	Low individual risk and low public health risk	A
B	Moderate individual risk and/or low public health risk	B
C	High individual risk and/or moderate public health risk	C
D	High individual risk and high public health risk	D

Medical devices registration process

Appointment of an authorized representative

As per medical devices regulation in Saudi Arabia, legal manufacturers must appoint an authorized representative (AR) company to be the point of contact concerning the related devices in Saudi. The AR will be responsible for product compliance and post-marketing surveillance. Read more: Authorized representative in Saudi Arabia – SFDA.

SFDA medical device registration

Medical device companies in Saudi Arabia must register their products at the SFDA and receive a medical device marketing authorization (MDMA) certificate. This is as per the published medical devices interim regulation in Saudi Arabia.

Medical devices registration (MDMA)

After the appointment of a Saudi Arabian authorized representative AR by execution of the AR agreement and issuing an SFDA AR license, the product application can be submitted through MDMA route.

MDMA registration requirements: Technical file

• Table of content
• Detailed device description/intended purpose/device history/Classification.
• Device labels and instructions for use
• Design and manufacturing information
• Essential Principles of Safety & Performance (formerly known as Essential Required checklist
• Benefit-risk analysis
• Risk Management File (Plan & Report)
• Product verification & validation, including
  • Pre-clinical testing & testing reports, including Biocompatibility testing reports.
  • Clinical investigation plan & report
  • Clinical Evaluation Report CER
  • Post Market Clinical Follow Up (PMCF)
• Post Market Surveillance (PMS), Plan & Report
• Periodic Safety Update Report (PSUR)– for class B, C, and D Devices

Besides the above-cited documents, SFDA officials may ask for further information during the application process.

Timelines

Application Type	Time Frame
Fresh Application	8-12 Weeks from submission to SFDA
Renewal/Update	6-8 Weeks from submission to SFDA

Fees

The SFDA fees vary according to the medical device Class and the number of products in the application. For details about that, read SFDA Fees.

Bundled applications

Device bundling is permissible; the applicant may bundle up to 50 items in one MDMA application. However, it must meet SFDA device criteria.

MDMA license validity

Three years.

Other notes

• The submitted application will be deleted without refund when SFDA returns the application due to failure to respond within (60) days.
• SFDA will reject the submitted applications without a fee refund when the applicant fails to respond within three trials.
• Medical device companies can initiate application renewal two months (60 days) before the expiry of the current MDMA certificate.
• Medical device companies can initiate updates in the application at any time in the existing documentation.
• Saudi-based companies must secure an SFDA medical device establishment license MDEL to be able to submit MDMA registration applications.
• Applicant must pay the SFDA fee within 30 days.

Regulatory support in Saudi Arabia

Whether you’re a new company in the Saudi market or already active commercially, we at PharmaKnowl can support you to have your products marketed in the shortest time. We ensure compliance and efficient regulatory support for our clients.

• PharmaKnowl is an SFDA licensed authorized representative in Saudi Arabia for international companies across the globe. We perform:
  • Files due diligence & Gap analysis on products and companies.
  • Preparations of Saudi-specific files and compilation of total technical files
  • Submission & interpretation of SFDA inquiries
  • Follow up until approvals are secured

Contact us for more information.

Read More:

• SFDA Registration & Market Regulations
• SFDA Fees
• SFDA Classification
• Medical Device Authorized Representative: SFDA Requirements
• SFDA Drug Registration Requirements & Approval Process