تسجيل جهاز طبي في هيئة الغذاء والدواء: الطريقة والرسوم والمدة

Saudi Arabia’s medical device regulations are being extensively updated by the SFDA medical devices sector in the past few years. By the end of 2021, the registration requirements are expected to become more complex with the heavy adaptation of the latest global standards. This article will clarify the basics of SFDA medical device classification and registration requirements for the multinational and local medical device companies in Saudi Arabia.

Medical Devices Regulation

According to the medical devices interim regulation in Saudi Arabia, the SFDA recognizes certain authorizations in other GHTF countries such as the European Union, United States, Canada, Australia, Japan, which simplifies the authorization process in Saudi Arabia. However, the last date for accepting applications through the GHTF route is 01/01/2022. Thereafter, all applications would be accepted through TFA (Technical File Assessment) route. In recent months, the SFDA has revised numerous requirements influenced by the MDR and IVDR.

Medical Devices approval process

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

  1. Identify the SFDA medical device classification.
  2. Appoint an authorized representative (AR), if needed
  3. Apply for SFDA Registration Approval (Medical Deceive Marketing Authorization MDMA)
  4. Ship to your one or more local distributor 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.

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

The SFDA MDS-G5 document details the classification rules which are similar to the European MDR classification rules.

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

Appointing an authorized representative

As per medical devices regulation in Saudi Arabia, multinational legal manufacturers must appoint an authorized representative AR company to register their high-risk medical devices in Saudi Arabia. On the other hand, Low-Risk devices (Non-measuring / Non-Sterile) do not require an authorized representative. Read more: Authorized representative in SFDA.

SFDA medical device registration

Medical devices companies in Saudi Arabia must register their products at the SFDA and receive a medical device marketing authorization MDMA certificate as per the published medical devices interim regulation in Saudi Arabia. This is applicable for the high-risk devices, while low risk (non-sterile / non-measuring) does not require the prolonged MDMA approval procedure.

Low Risk (Class I) Medical Devices Registration

Low-risk medical devices in Saudi Arabia (sometimes known by “Medical Supplies”) need to be registered at the SFDA to be listed in the Medical Device National Registry MDNR. This is only applicable for the low-risk Medical devices, which are Class I but non-sterile and non-measuring products.

Although it is an easier registration procedure, it still requires a good set of documents, and 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 that companies must furnish to satisfy their query.  

Registration Validity

Three years

Timelines

The low-risk medical device registration time frame in Saudi Arabia is expected to be from 1 to 2 weeks, this depends on the amount of SFDA inquiries and the time needed by the company to provide the response.

Fees

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

Renewal

Registration Renewal shall be made before (60) days of the validity expiration date of “Medical Device National Listing Numbers”.                                                               

High-Risk Medical Devices Registration

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

To secure MDMA, companies can register through different reference jurisdictions GHTF. Note that SFDA will mostly request the technical file details during the approval process even when the applicant is applying through the EU or US jurisdiction route. The technical file will be soon the only way to register on 1 Jan 2022.

EU Jurisdiction – Registration Requirements

  • Product label, which must meet 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 Authorisation Statement

US Jurisdiction – Registration Requirements

  • Product label, which must meet 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 Authorisation Statement

Technical File – Registration Requirements

  • Table of content
  • Detailed device description/intended purpose/device history/Classification.
  • Device labels and instruction 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
    • 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 any further documents or 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 for medical devices vary according to the Class and sometimes it is affected by the number of products in each application. For details about that, read SFDA Fees.

Bundled Applications

Device bundling is permissible where up to a maximum of 50 can be bundled in one MDMA application. However, it must meet SFDA device bundling criteria.

MDMA License Validity

Three years.

Notes

  • SFDA will return the submitted application if the fee is not paid within (30) days from the date of receiving the invoice from SFDA.
  • 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 fee refund when the applicant fails to respond within three trials.
  • Medical device companies can initiate application renewal 2 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.

Supporting Saudi Arabia medical device registration

Whether you’re a new company to the Saudi Arabia 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.

At PharmaKnowl, we provide the authorized representative service for legal manufacturers in Saudi Arabia with full regulatory and supply chain support. Contact us for more information.

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