Saudi Arabia Market Access
Saudi Food and Drug Authority (SFDA)
The (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, Deliberate Consulting can fully support your medical device registration in the KSA.
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.
SFDA Authorized Representative for medical device manufacturers
An experienced, third-party representative is in the best position to serve the best interests of your company in Saudi Arabia. Your AR must field questions from the SFDA and perform post-market obligations, if necessary. They should protect your intellectual property and allow you to control your distribution options.
It is possible to appoint a distributor as your AR. But this can create unforeseen complications, especially when dealing with inquiries from the SFDA and other complex regulatory matters.
As your KSA Authorized Representative, we will act as your regulatory liaison with the SFDA and fully manage your registration effort. Here is how we can help:
- Submit your medical device registration to the SFDA
- Administer all registration fees
- Notify the SFDA of any changes to your device
- Coordinate adverse event reporting to the SFDA with you and your distributors
- Support device recalls or Field Safety Corrective Actions (FSCA) if needed
- Liaise between you and the SFDA
We are a fully independent Authorized Representative with experience handling medical device regualtory processes in Saudi Arabia.
How can we transfer to a new authorized representative in the KSA?
It is possible to obtain a new authorized representative; however, it requires a new AR license. You must cancel the existing AR license before requesting a new one. You cannot submit an AR transfer request if your MDMA application is in process. Emergo can assist with AR transfer requests.
Can we select more than one AR?
If you are marketing several devices that fall into different categories (e.g., single-use devices versus electromechanical devices), you can have different ARs for each category, though it is not required. You may use one AR for all product categories. Manufacturers can also have more than one AR for the same product category by specifying the product range that will be represented by each AR within the individual AR mandates.
Do we need an AR license?
If it is your first time to market, you must obtain an AR License through the SFDA Medical Device Establishment Licensing System (MDEL).
Who "owns" the MDMA approval – the AR or the manufacturer?
The MDMA is issued in the manufacturer’s name; the manufacturer owns the registration.
SFDA registration requirements for medical devices
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:
- 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
- Classification
- 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)
- Barcodes
- 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)
- Bill of materials
- Description of function and assembly of the device
- Technical specifications
- Manufacturing process flow
- Declaration of Conformity – See Annex 14 of MDS-REQ 1 for template.
- Procedure
- 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)
Saudi Arabia medical device registration FAQs
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.