SFDA Medical Device Registration

The Saudi Food and Drug Authority (SFDA) has extensively updated the medical device regulations in Saudi Arabia. Mainly between 2019 and 2022, which increased the complexity of the SFDA registration. That affected the medical device classification and changed the concept and the content of the medical device marketing authorization MDMA (high-risk application). Moreover, we expect the disappearance of MDNR (Medical Device National Registry) within 2022, the famous low-risk device procedure. Therefore, the authorized representatives (AR) in Saudi Arabia are facing major projects since all previously approved devices, IVDs, and simple medical supplies must comply with advanced regulations. Similar to the EU MDR, more files, test reports, and time to reach approval.

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.

Who can apply to SFDA?

Authorized Representatives can register products in the SFDA, such as:

  • Consulting companies
    • Independent authorized representatives (AR)
    • Ability to ship to multiple importers/distributors in Saudi.
    • Advanced compliance knowledge and experience.
    • More control over the in-market activities.
  • Local importers/distributors
    • Low cost

Medical devices regulations in Saudi

According to the medical devices interim regulation in Saudi Arabia, the SFDA recognizes specific 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 (high-risk devices) must undergo the Technical File Assessment (TFA) procedure. In recent months, the SFDA has revised 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 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 will no longer be available starting from Sept 2022. All low-risk devices will be required to re-register through the MDMA route, which requires a TFA application.

The medical devices approval process

We can summarize the registration process for a medical device in Saudi Arabia in the following few steps:

  1. Identify the SFDA medical device classification.
  2. Appoint a Saudi authorized representative (AR), if needed
  3. Apply for SFDA Registration Approval (Medical Deceive Marketing Authorization MDMA)
  4. Ship the product to one or more local distributors in Saudi Arabia

In the following sections, we will describe in detail the approval process:

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 ClassificationRisk ClassMDR Classification Rule
ALowI
A – SterileLow-mediumIs
A – Measuring functionLow-mediumIm
A – Reusable surgical instrumentsLow-mediumIr
BLow-mediumIIa
CMedium-highIIb
DHighIII

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 ClassificationRisk ClassClassification Rule
ALow individual risk and low public health riskA
BModerate individual risk and/or low public health riskB
CHigh individual risk and/or moderate public health riskC
DHigh individual risk and high public health riskD

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.

On the other hand, Low-Risk devices (Non-measuring / Non-Sterile) do not require an authorized representative.

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 per the published medical devices interim regulation in Saudi Arabia. MDMA is needed for the high-risk devices, while the low risk (non-sterile / non-measuring) does not require the prolonged MDMA, but they have their listing procedure in SFDA.

1- Low risk (Class I) medical devices registration

The SFDA requires the companies of low-risk medical devices (Medical supplies) to register their products in the Medical Device National Registry MDNR. It is a listing procedure applicable only for low-risk devices, Class I, but non-sterile and non-measuring products. During the listing process, companies should expect a lot of SFDA inquiries back and forth till approval.

There are two routes of registration for low risk (Non-Sterile, Non-measuring). The routes and their requirements are:

Abridged route requirements

  • Product label
  • Instruction for Use (IFU)
  • ISO 13485: 2016
  • Country (Saudi Arabia) specific declaration of conformity
  • Evidence of registration in reference jurisdictions

Direct route requirements

  • Product label
  • Instruction for Use (IFU)
  • ISO 13485: 2016
  • Country (Saudi Arabia) specific declaration of conformity

Note that the above-cited documents are the standard requirements for registering Class I (Low-Risk, Non-Sterile, Non-Measuring devices). However, it is pertinent to mention that the SFDA reviewer may ask for additional requirements or information.  

Registration validity

Three years

Timelines

The low-risk medical device registration time frame in Saudi Arabia is usually from 1 to 2 weeks; this depends on the amount of SFDA inquiries and the time the company needs to respond.

Fees

Class I low risk medical device Fee: SAR 500 / device    

Renewal

Registration renewal is available before (60) days of the validity expiration date of the Medical Device                                                                

2-High-risk medical devices registration (MDMA)

As we mentioned earlier, high-risk medical devices in Saudi Arabia require the appointment of a Saudi Arabian authorized representative AR and registration in the Medical Device Marketing Authorization (MDMA) route. The execution of the AR agreement and subsequent SFDA AR license is mandatory before product application submission.

MDMA Registration and approval process SFDA Saudi Arabia
Class II and III registration flow chart in SFDA

Companies used to be able to submit MDMA through different reference jurisdictions GHTF. However, the TFA procedure is the only track accepted for the MDMA application since Jan 2022.

EU Jurisdiction – Registration Requirements (Deprecated)

  • The product label must meet the Labelling criteria of SFDA
  • EC Declaration of Conformity (from manufacturer)
  • Instruction of use (IFU)
  • Marketing Material/Brochure
  • Notified Body name with their number
  • EC certificate (Full Quality Assurance)
  • ISO 13485: 2016
  • Most recent audit report with audit finding report
  • Country (Saudi Arabia) specific statements (templates) from SFDA
    • Environmental factor statement
    • Marketing Authorization Statement

US Jurisdiction – Registration Requirements (Deprecated)

  • The product label must meet the Labelling criteria of SFDA
  • Instruction of use (IFU)
  • Marketing Material/Brochure
  • Notified Body name with their number
  • ISO 13485: 2016
  • Most recent audit report with audit finding report
  • 510K Clearance/Exempt or PMA Proof
  • Establishment Registration & Device Listing (Screenshots from FDA site)
  • Country (Saudi Arabia) specific statements (templates) from SFDA
    • Environmental factor statement
    • Marketing Authorization Statement

Technical file – registration requirements

  • 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 TypeTime Frame
Fresh Application8- 12 Weeks from submission to SFDA
Renewal/Update6-8 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

  • Applicant must pay the SFDA fee within 30 days.
  • 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 submit registration applications or proceed with the distribution of medical devices.

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 worldwide.
  • 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.

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