Pharmaknowl - Logo

SFDA Medical Device Registration

Share it on

The Author

Regulatory Editor

Between 2019 and 2022, the Saudi Food and Drug Authority (SFDA) extensively updated the medical device regulations in Saudi Arabia. In particular, the requirements for medical device marketing authorization (MDMA) had evolved to cope with EU Medical Device Regulations (MDR) updates. The continuous development and reengineering of the registration procedures increased the complexity of the SFDA registration process. To market in Saudi, all medical devices, including low-risk classes and in vitro diagnostics(IVDs), must be MDMA registered through the technical file application (TFA) route.

In this article, we will clarify the SFDA medical device registration requirements and the details of the abovementioned updates. We will also define the differences in the classification of medical devices according to EU regulations.

Products Regulation

The SFDA is responsible for regulating medical device products in Saudi Arabia. They ensure their safety, efficacy, and quality. All medical device legal manufacturers must acquire MDMA SFDA approval before marketing the product. Post-approval, they are responsible for product safety and other life cycle management, such as MDMA updates, renewals, and providing the Unique Device Identification (UDI) information.

Here is a summary of the registration procedures for medical devices:

MDMA (TFA)

Since January 2022, all medical devices, equipment, supplies, software/apps, and IVD products must be registered through one MDMA registration route called TFA (or MDMA2). This route has resulted from the SFDA’s continuous updates of regulations influenced by the EU MDR and IVDR. It requires presenting the technical documentation in a clear, organized, readily searchable, and unambiguous manner.

Therefore, the registration requirements became more stringent, with many conditions to meet and studies to provide, such as clinical evaluation reports (CER), biocompatibility test reports, and the need to conduct a post-market clinical follow-up (PMCF) study in Saudi Arabia.

Although the TFA file is similar to the CE mark file, having a CE certificate to receive SFDA approval is not mandatory. However, the product will mainly undergo a more rigorous assessment requiring an experienced regulatory professional.

GHTF (Cancelled)

The SFDA used to consider approvals from the GHTF members’ countries such as the European Union EU, United States, Canada, Australia, and Japan. This was an easy referencing route without deep technical inquiries. However, SFDA cancelled this GHTF route by the end of 2021.

MDNR (Cancelled)

The non-sterile, non-measuring Low-Risk Medical Devices used to be registered through the Medical Device National Registry (MDNR), also known as “Medical Devices Listing”, which is exempted from MDMA. However, in September 2022, the SFDA cancelled the MDNR procedure. This simple application isn’t available anymore so all devices must have a technical file, and appoint an authorized representative (AR) in Saudi Arabia.

Companies Regulation

The SFDA also regulates medical device companies in the Saudi market and enforces special requirements on international companies. Below are the requirements for both types:

Local Saudi Company

The SFDA licenses local medical device companies such as importers, distributors, warehouses, and manufacturers. This license is called the Medical Device Establishment License (MDEL). All previous types of companies must implement a quality management system (QMS) and have an ISO 13485 certificate. This ISO must be maintained valid to keep the license, which is frequently checked during SFDA inspections.

International legal manufacturers must appoint an authorized representative (AR) company in Saudi Arabia; it is the first step to enable communication with the SFDA. The AR’s primary responsibility is product compliance in pre and post-marketing activities. The AR will maintain registration status, facilitate shipments, monitor safety, report cases, and represent the company in the Saudi market for regulatory or governmental matters. The SFDA issues the AR certificate for a minimum of 1 year and must be maintained valid during commercial activities in Saudi.

Medical Device Classification

The applicant is responsible for classifying the product according to SFDA rules and creating the related files in the technical file. 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 cases where SFDA did not adopt the same. For instance, a product is considered a low-risk medical device in its home country but a non-medical device in Saudi Arabia, 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 table below:

SFDA ClassificationRisk ClassMDR Classification Rule
Class ALowI
Class A – SterileLow-mediumIs
Class A – Measuring functionLow-mediumIm
Class A – Reusable surgical instrumentsLow-mediumIr
Class BLow-mediumIIa
Class CMedium-highIIb
Class DHighIII
Medical Device Classification in Saudi Food and Drug Authority (SFDA)

The applicant is responsible for the classification of their device in Saudi according to the following Risk Classification Rules for Medical Devices:

  • Intended use.
  • Risk level (harm probability and severity to the patients, users, and others).
  • Invasiveness to the human body.
  • Use duration.

Identical devices could be classified differently according to the targeted part of the body. Therefore, the intended use is crucial in determining the correct classification. The intended use is clarified in the following:

  • Instructions for Use (IFU)
  • Label
  • Promotional materials
  • Technical File

Concerning in vitro diagnostics, the SFDA is also adopting the European medical device regulation IVDR:

SFDA IVD ClassificationRisk ClassClassification Rule
Class ALow individual risk and low public health riskA
Class BModerate individual risk and/or low public health riskB
Class CHigh individual risk and/or moderate public health riskC
Class DHigh individual risk and high public health riskD
IVD Classification in Saudi Food and Drug Authority (SFDA)

The applicant is responsible for determining the class of the IVD by:

  • Applying the classification rules for IVD medical devices, and
  • Considering:
    • Intended use
    • Level of risk

Registration Requirements

The first step is to appoint an authorized representative for every unique legal manufacturer by submitting a signed AR agreement to receive an AR license from the SFDA. Afterwards, the applicant can submit the product registration application.

MDMA Registration and approval process SFDA Saudi Arabia

The following are the requirements summary. They vary according to the product type and class. In addition, the applicant must apply many Saudi market-specific requirements to comply, they need to be made before submission since SFDA does not point out to them during assessment. Here are the high-level sections of the registration 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)
  • 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

Registration Process

Time needed: 90 days

We can summarize the medical device registration (MDMA) approval process in the following few steps:

  1. Appointing an Authorized Representative (AR)

    Manufacturers must appoint an AR to represent their company in Saudi Arabia. This is not related to the commercial operations. They can appoint their distributor as an AR or opt for the professional option, the independent AR.

  2. Gap Analysis

    Companies need to establish a thorough gap analysis on the registration 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. It also protects from rejection which costs time and government fees.

  3. MDMA Submission

    The applicant submits the technical file accurately to the SFDA through the advanced registration platform (Ghad). The application is called Medical Device Marketing Authorization (MDMA). Contact us to request a registration service.
    sfda ghad system

  4. Validation

    The SFDA will perform a quick compliance check to ensure that the MDMA application is submitted according to the guidelines. This step doesn’t include a content review. Any incompliance with the submission will result in a rejection of the application without providing the actual reason. The assessor will request the applicant to re-apply according to the guidelines. The applicants will have few chances to rectify.

  5. Payment of Fees.

    If the file passes the initial validation, the applicant will receive an invoice to pay the SFDA fees. This must be paid before the start of the assessment, and it is not refundable.

  6. Application Assessment

    The assessors will review the product file and send back their inquiries in multiple waves as the application goes through various layers of assessment. The assessor does not guide or detail the deficiency but will point out the concerning section or study and request the applicant to comply.

  7. MDMA Approval

    When granted by SFDA, the license owner (the legal manufacturer) can ship the goods to the Saudi market.

Multiple Devices

Grouping multiple devices in the same application is permissible; the applicant may bundle up to 50 items in one MDMA application. However, products must meet several conditions, such as having the same risk class and intended use.

Timelines

The assessment timelines vary according to many factors, such as risk factors, complexity of the product, number of bundled SKUs (accessories and variants), and the completeness of the file. Non-identified gaps before the submission will risk delaying the approval. The entire timelines for the registration project include:

  • Gap Analysis Time
    This part depends on the amount and type of gaps, the speed of manufacturer feedback, and the experience of the regulatory staff.
  • SFDA Assessment Time
    For the official review timelines, refer to our article SFDA timelines.

Fees

The MDMA application fees vary according to the medical device Class and the number of products in the application. For the updated fees, please refer to our updated SFDA Fees post.

MDMA Renewal and Update

MDMA is valid for three years. Companies can submit the renewal application three months (90 days) before the license expires. Regarding the update of an approved device, There are minor and major update types; both differ in fees and timelines. They can be submitted at any time during the license validity.

MDMA Certificate

SFDA will issue an MDMA certificate in both Arabic and English containing the following:

  • The manufacturer’s information
  • Sufficient information to identify the medical device or the medical devices group.
  • Medical Device National Listing Numbers for the medical devices included in the MDMA.
  • The period of its validity
  • Certificate number

Medical Device Importing License (MDIL)

Importing medical devices requires valid MDMA. However, the SFDA may exempt any medical device from the marketing authorization, they only require importers to issue a medical device importing license (MDIL). The SFDA announces the exempted medical devices on its website taking into consideration the public interest. Examples:

  • Medical devices intended for demonstration or training purposes only.
  • Chemicals (finished product) whether classified as a medical device or used along with medical devices (e.g. gases used to calibrate medical devices, as well as chemicals used to ensure the sterilization or operation of medical devices, manufacturing of prostheses, or preservation of tissues or cells). Excluding the following products (if the chemical is classified as a medical device and the device required to have MDMA).
    • Radioactive materials
    • Medical IVD
    • Non-medical IVD
    • Chemical precursors.
  • Distillation apparatuses imported for healthcare providers or educational medical facilities
  • Research and Educational use products
  • Semi-finished medical devices/supplies (and raw and non-raw chemicals) for the purpose of local manufacturing (manufacturing includes refurbishing, assembling, packaging, and labelling).

Registration Service

Whether your company is new or already active in the Saudi market, PharmaKnowl will help you comply with SFDA. We are an SFDA-licensed consulting company that provides regulatory and authorized representative services in Saudi Arabia for international companies across the globe. We perform:

  • Products registration
  • Post-marketing support (Safety and compliance cases)
  • Authorized representative (AR)

Contact us for more information.

Need Support?

We support global Pharma and Medical Devices companies in the Saudi market with professional regulatory services. Send us your request to kick off your SFDA project.

Start Here

The Author

Regulatory Editor

Pharmaknowl - Subscribe to our Newsletter

Subscribe to our Newsletter to receive the latest SFDA news and insights.

Insights

Discover All Insights

Exploratory Consultation Schedule an online meeting to discuss your business needs.

Pharmaknowl - Find out how we can help your business
© PhamaKnowl - 2024, All Rights Reserved
Pharmaknowl - Logo