Successfully navigating the SFDA medical device registration in Saudi Arabia, particularly the Medical Device Marketing Authorization (MDMA) process, is essential for manufacturers seeking entry into the rapidly expanding Saudi market.

The requirements for MDMA have evolved to cope with the advancement of international standards, such as the evolution from EU Medical Device Directives (MDD) to Medical Device Regulations (MDR). The continuous development of medical device regulations increased the complexity of the process.

For example, low-risk medical devices require a Saudi authorised representative (AR) and MDMA approval since SFDA cancelled the Medical Device National Registry (MDNR).

We at PharmaKnowl offer expert support for the registration process. Whether you’re dealing with new devices or modifying existing products, our team provides the strategic insight and technical expertise needed to achieve timely and successful market entry in Saudi Arabia.

This article clarifies the SFDA medical device registration requirements and defines their classification differences. For other types of product registration, refer to the SFDA registration post.

Registration Applications

The SFDA regulates medical device products in Saudi Arabia to ensure their safety, efficacy, and quality. The manufacturers must acquire MDMA approval 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:

MDNR (Low Risk) – 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.

MDMA 1 (GHTF) – Cancelled

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

MDMA 2 (TFA)

Since January 2022, all medical devices and in vitro diagnostics (IVDs) must secure SFDA authorisation through the TFA registration route (MDMA2). This route has resulted from the authority’s continuous regulation updates influenced by the EU MDR and IVDR. It 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 requirements are similar to those of the EU (CE mark), the SFDA does not require a CE certificate. However, if the product file doesn’t carry a CE mark, it will undergo a rigorous assessment.

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

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

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 risk Class and the number of products in the application. For more information, refer to our updated SFDA Fees post.

Renewal

MDMA’s default validity is three years. When it is near expiration, manufacturers can submit an MDMA renewal application up to three months (90 days) before the license expires. If it is an MDMA1 (GHTF), the renewal process will be long and require extensive requirements. In contrast, MDMA2 (Technical file) expect a faster renewal process.

Update

To make changes to the registered medical device, manufacturers must submit an MDMA update application. The SFDA categorises the change types into significant (major) or insignificant (minor). Both differ in fees and timelines; applicants can submit them anytime during the license’s validity. Note that minor changes do not require approval, but the manufacturer must notify the SFDA before implementation.

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

Product Categories

The SFDA classifies a wide range of products as medical devices in Saudi Arabia under its regulations. These include, but are not limited to:

• Diagnostic Devices:
  • Imaging Equipment: X-ray machines, CT scanners.
  • Monitoring Devices: ECG machines and blood pressure monitors.
  • In Vitro Diagnostic Devices: Pregnancy tests, blood glucose meters.
• Therapeutic Devices:
  • Respiratory Devices: Ventilators, nebulizers.
  • Infusion Devices: Insulin pumps, IV therapy equipment.
  • Rehabilitation Devices: Wheelchairs, prosthetics.
• Implantable Devices:
  • Cardiovascular Devices: Pacemakers, stents.
  • Orthopaedic Implants: Hip replacements, spinal rods, joint replacements.
• Surgical Instruments:
  • Cutting Instruments: Scalpels, surgical scissors, forceps.
  • Staplers and Sutures: Surgical staplers, absorbable sutures.
• Dental Devices:
  • Restorative Materials: Dental crowns, fillings.
  • Orthodontic Appliances: Braces, retainers.
  • Other: dental drills
• Ophthalmic Devices:
  • Corrective Lenses: Contact lenses, eyeglasses.
  • Surgical Equipment: LASIK machines, intraocular lenses.
• Medical Software (SaMD):
  • Diagnostic Software: AI for image analysis.
  • Treatment Planning Software: Radiation therapy planning tools.
• Laboratory Equipment:
  • Analyzers: Blood gas analyzers and haematology analyzers.
  • Sterilization Equipment: Autoclaves, UV sterilizers.
• Home Healthcare Devices:
  • Monitoring Devices: Blood glucose monitors and digital thermometers.
  • Mobility Aids: Walkers, electric scooters.
• Therapeutic devices (e.g., dialysis machines)

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).

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.