SFDA Medical Device Registration

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 authorisation (MDMA) had evolved to cope with EU Medical Device Regulations (MDR) updates.

The continuous development of medical device registration procedures increased the complexity of the 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 define the differences in the classification of medical devices according to EU regulations.

For other types of product registration, refer to the SFDA registration post.

Products Regulation

The SFDA regulates medical device products in Saudi Arabia to ensure their safety, efficacy, and quality. Medical device manufacturers must acquire SFDA approval (MDMA) before marketing their products. Post-approval, they are responsible for safety reporting and other life cycle management, such as MDMA update, renewal, and submission of the Unique Device Identification (UDI).

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 have SFDA approval through the MDMA registration route called TFA (MDMA2). This route has resulted from the SFDA’s continuous regulations updates influenced by the EU MDR and IVDR. This route requires presenting the technical documentation in a clear, searchable, and organised 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, without a CE mark, the product file will undergo a rigorous assessment requiring an experienced regulatory professional.

GHTF (Cancelled)

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

MDNR (Cancelled)

Companies used to register Non-sterile, non-measuring, Low-Risk Medical Devices through the Medical Device National Registry (MDNR), also known as “Medical Devices Listing,” which is exempt from MDMA and AR. However, in September 2022, the SFDA cancelled the MDNR procedure. Therefore, all devices must have a technical file for MDMA with an appointed (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.

Legal Manufacturer

International legal manufacturers must appoint an authorised representative (AR) company in Saudi Arabia; this is the first step in enabling 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.

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 EU regulation (CE certificate). However, SFDA will not consider other countries’ regulations; a low-risk medical device in a country could be high risk 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 Classification	Risk Class	MDR Classification Rule
Class A	Low	I
Class A – Sterile	Low-medium	Is
Class A – Measuring function	Low-medium	Im
Class A – Reusable surgical instruments	Low-medium	Ir
Class B	Low-medium	IIa
Class C	Medium-high	IIb
Class D	High	III

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

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

After appointing an authorised representative, the applicant can submit the product registration application. The following summarises the requirements, which vary according to the product type and class. Here are the high-level sections of the registration file:

• Table of content
• Device description
• Intended use/purpose
• Device history
• Device Classification.
• Device label
• Device Models, accessories, and Variants
• Instructions for use
• Design Information
• Manufacturing Information
• Essential Principles (EP List) of Safety & Performance (Essential Required checklist)
• Benefit-risk analysis
• Risk Management File (Plan & Report)
• Pre-clinical testing
• Testing reports
• Biocompatibility Test 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 medical devices.

Registration Process

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 class, complexity of the product, number of bundled products, 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 regulatory staff’s experience.
• 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.

Renewal and Update

MDMA’s default validity is 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. Applicants can submit them at any time during the license’s validity.

MDMA Certificate

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

• The manufacturer’s information
• Medical device and medical device group information.
• Medical Device National Listing Numbers.
• Validity Period
• Certificate number

Medical Device Importing License (MDIL)

Importing medical devices requires valid MDMA. However, the SFDA may exempt some medical devices from registration and only require them to issue a medical device importing license (MDIL). For example:

• Demonstration or training purposes medical devices.
• 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 sterilisation or operation of medical devices, manufacturing of prostheses and preservation of tissues or cells). They are excluding the following products (if the chemical is classified as a medical device and the device must have MDMA).
  • Radioactive materials
  • Medical IVD
  • Non-medical IVD
  • Chemical precursors.
• The distillation apparatuses for healthcare providers or educational facilities.
• Research and Educational use products.
• Semi-finished medical devices/supplies (and raw and non-raw chemicals) for local manufacturing (manufacturing includes refurbishing, assembling, packaging, and labelling).

Registration Service

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

Contact us for more information.