ANSWERED ON THIS PAGE:
- What is the medical device registration process in Saudi Arabia?
- How does Saudi Arabia classify medical devices and IVDs?
- Do we need an in-country representative in Saudi Arabia?
The Saudi Food and Drug Authority (SFDA) regulates medical devices and IVDs sold and distributed in Saudi Arabia. A Medical Device Market Authorization (MDMA) from the SFDA is required to market medical devices (including IVDs) in the Kingdom of Saudi Arabia (KSA). The SFDA meticulously reviews MDMA applications, so prepare your submission carefully to ensure timely approval. With assistance from our colleagues in Riyadh, Emergo by UL can fully support your medical device registration in the KSA.
What is needed before submitting a medical device registration?
The SFDA’s newly established Saudi route requires a Technical File Assessment (TFA) for market authorization, and the SFDA has implemented its own classification system for medical devices. Prior approval in the country of origin is not a pre-requisite for registration in the KSA, and reference country approval is not required for MDMA registration; however, any existing proof of approval in other markets is requested as part of the documentation for registration.
You must also appoint a Saudi Arabia Authorized Representative if you do not have an office or entity in Saudi Arabia. Your Authorized Representative (AR) must obtain an Authorized Representative License, which is renewable on an annual basis, to legally represent you in the KSA. Your KSA Authorized Representative is also responsible for submitting all application documents to the SFDA to register your device.
Submitting applications to the SFDA
All application documents are submitted electronically via the SFDA’s Unified Electronic System, or GHAD. SFDA submissions must be provided in English and include the following documentation:
Device information (including accessories)
- Trade name (in English and Arabic if the device is intended for lay use)
- Model name(s)/number(s), catalog number(s), etc. (for software, the major version number may be used for this purpose)
- Device description
- Intended purpose
- Evidence of approval in other countries, if available
- Labels and packaging; power supply label, where applicable
- Instructions for use (IFU) or justification letter, if not available
- Information on storage, transportation, installation, maintenance and disposal (may refer to IFU)
- Currently only required for lay-use devices
- See the Unique Device Identification (UDI) section for information about the SFDA’s implementation of UDI requirements for all devices.
- Proposed advertising material
- For software, the SFDA generally requests an explanation of the version digits (e.g., which digit represents a significant/major change, and which digit indicates a minor change)
Design and manufacturing information
- Bill of materials
- Description of function and assembly of the device
- Technical specifications
- Manufacturing process flow
Essential principles checklist
- Declaration of Conformity – See Annex 14 of MDS-REQ 1 for template.
Benefit-risk analysis and risk management
- Risk management plan
- Risk analysis
- Risk management report
Product verification and validation
- Pre-clinical data
- Clinical data
Post-market surveillance plan
Periodic Safety Update Report (or Post-market surveillance report for Class A medical devices/Class A and B IVDs)
The above is an abbreviated summary of information and documents that must be included in the Technical Documentation File submitted for MDMA registration for most devices (Class A medical devices that are not IVDs, sterile, measuring, reusable surgical instruments, and/or novel have abbreviated requirements, as described in the “Submitting to SFDA” section of MDS-REQ 1.)
Emergo helps with medical device approvals in Saudi Arabia
Emergo is an international consulting firm that works exclusively for medical device and IVD companies. Our experienced team is equipped to assist with all aspects of the SFDA registration process. Here is what we can do:
- Help you identify the correct medical device and IVD classification, based on the SFDA’s classification system.
- Function as your Authorized Representative, prepare and authenticate AR license.
- Communicate with SFDA on your behalf as your Authorized Representative.
- Prepare and submit your Medical Device Marketing Authorization (MDMA) application.
- Prepare and submit authorization and AR license renewals or transfers.
- Assist with import authorization documentation.
With offices in the Middle East, Europe, North America, and beyond, Emergo can help you start selling in Saudi Arabia and in markets around the world.
Please contact us for more information on medical device registration in the Kingdom of Saudi Arabia.
Common questions regarding medical device registration and approval in Saudi Arabia
How long is the SFDA review process?
The SFDA allots 35 working days as its official timeframe for reviewing applications; however, actual review times are often longer, particularly if additional information is requested.
When do SFDA approvals expire?
Under the Saudi route, MDMA registrations have a maximum validity of three years.
For products initially registered under the Global Harmonization Task Force (GHTF) route, leveraging reference country approval, MDMA renewals for Class I self-certified devices and general IVDs last for three years. For all other medical device classes, approvals are valid either for the remainder of the reference country approval, if there is an explicit expiration date, or three years if the SFDA considers the reference country market authorization to be open-ended.
What is the Gulf Countries Council (GCC)?
The GCC (Cooperation Council for the Arab States of the Gulf, previously known as the Gulf Cooperation Council) is a political and economic union that comprises the six Arab states of the Persian Gulf: Saudi Arabia, the UAE, Bahrain, Oman, Kuwait, Qatar, plus Yemen. The GCC developed a group purchasing program that covers all member states, offering significant opportunity to foreign manufacturers. Our colleagues in Riyadh provide consulting and representation support with elements of the tender process.
Do all devices require MDMA approval?
Yes. All medical devices and IVDs that meet the definition of a medical device as outlined in Article 1 of the Medical Devices Law require MDMA approval.