Who Needs to Comply?
The SFDA's Medical Devices Law and its Implementing Regulation impose obligations on multiple parties across the device supply chain. Understanding your role — and the corresponding requirements — is essential before placing a device on the Saudi market.
Foreign manufacturers
A foreign manufacturer (a legal manufacturer without a physical office or legal entity in Saudi Arabia) cannot sell or distribute devices in KSA without:
- Appointing an Authorized Representative (AR) licensed by the SFDA
- Obtaining MDMA for each device or group of devices (via TFA)
- Implementing and certifying a QMS to ISO 13485 (or SFDA.MD/GSO ISO 13485)
- Fulfilling post-market obligations — PMS, vigilance, MDMA renewal
The foreign manufacturer remains the legal responsible party for device safety and performance, even where an AR handles the regulatory interface.
Foreign manufacturers who do not wish to share confidential technical documentation with their AR may submit the technical file directly to SFDA via the GHAD portal. The AR still must hold a license and act as the official in-country contact.
Authorized Representatives (AR / LAR)
An Authorized Representative is a Saudi-licensed entity — an individual or a company — appointed by the foreign manufacturer to:
- Submit and manage MDMA applications via GHAD
- Hold and maintain the MDMA certificate on behalf of the manufacturer
- Communicate with the SFDA on regulatory matters
- Fulfil post-market obligations (vigilance, FSCAs) in-country
- Ensure Arabic labelling compliance for home-use devices
The AR must hold a valid AR license (annually renewable) issued under the MDEL system. The AR's name and contact details must appear on device labelling, packaging, and IFU.
In Saudi Arabia, the MDMA certificate is held in the name of the AR, not the manufacturer. Changing your AR can therefore complicate or delay product distribution. Consider contracting an independent AR service provider rather than designating your distributor as AR.
Importers
Any entity importing medical devices into KSA — other than those imported directly by the MDMA certificate holder — must hold a Medical Device Establishment License (MDEL) as an importer and, where applicable, a Medical Device Importing License (MDIL) for exempted categories.
Importers must:
- Verify that devices carry a valid MDMA before importation
- Maintain distribution and traceability records
- Report adverse events to the SFDA (NCMDR)
- Cooperate with FSCAs and recalls
Distributors
Distributors operating within Saudi Arabia must hold an MDEL (distributor category) and implement a QMS. Their obligations include:
- Distributing only MDMA-authorised devices
- Maintaining storage and handling conditions
- Keeping distribution records for traceability
- Reporting adverse events and field safety actions
- Cooperating with SFDA inspections
Healthcare providers
Hospitals, clinics, diagnostic laboratories, and other healthcare providers in Saudi Arabia hold post-market vigilance obligations:
- Report serious incidents (adverse events) involving medical devices to the NCMDR
- Participate in FSCA implementation
- Maintain records of device use
Healthcare providers do not require MDMA or MDEL for the use of registered devices in their facilities.
Manufacturers with a Saudi legal entity
A foreign manufacturer that has established a legal presence in Saudi Arabia (branch office, subsidiary) may not require a separate AR — but must still hold an MDEL and comply with all registration and post-market obligations directly.
Summary of key obligations by role
| Role | MDMA | MDEL | ISO 13485 QMS | Vigilance |
|---|---|---|---|---|
| Foreign manufacturer | ✅ (via AR) | Not required (AR holds) | ✅ | ✅ |
| Authorized Representative | Holds certificate | ✅ (AR license) | ✅ | ✅ |
| Importer | Not holder | ✅ | ✅ | ✅ |
| Distributor | Not holder | ✅ | ✅ | ✅ |
| Healthcare provider | ✗ | ✗ | ✗ | ✅ (reporting) |