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.
Table of contents
- Medical devices regulations in Saudi
- Medical devices classification
- Medical devices registration process
- Appointment of an authorized representative
- SFDA medical device registration
- Regulatory support in Saudi Arabia
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 – Sterile||Low-medium||Is|
|A – Measuring function||Low-medium||Im|
|A – Reusable surgical instruments||Low-medium||Ir|
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
Time needed: 90 days.
We can summarize the medical device registration and approval process in the following few steps:
- Appoint a Saudi authorized representative (AR)
Through a knowledgeable AR, legal manufacturer can have the advanced regulatory support with the ever changing SFDA regulations. Even if there was an appointed AR before, manufacturers can transfer to a new AR and transfer all old MDMA approvals. Contact us for more details.
- Prepare the technical file for MDMA submission
To be ready for MDMA submission, companies need to establish a thorough gap analysis on the available file against the SFDA requirements. Identifying the gaps is essential to determine the must have studies, reports, or post approval commitments such as PMCF in Saudi. Rejection of an application costs time and high SFDA fees.
- MDMA Submission
The SFDA evaluators will not accept to receive a registration file that’s is clearly submitted by a non specialized regulatory professional. The feedback from the SFDA will not clarify the gaps and what needs to be done, they will ask the applicant to resubmit according to the applicable guidelines. However, if it was prepare in a good way, applicant should expect technical inquiries similar to those received from notified bodies. The applicants will have few permitted waives of responding to inquires and a time window.
- MDMA Approval
Once granted by SFDA, the owner of the license, which is always the legal manufacturer, can ship the goods to Saudi with all necessary SFDA requirements for shipment clearance at Saudi ports.
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.
|Application Type||Time Frame|
|Fresh Application||8-12 Weeks from submission to SFDA|
|Renewal/Update||6-8 Weeks from submission to SFDA|
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.
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
- 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.