Saudi SFDA Medical Device Registration (MDMA) Guide 2026

As Saudi Arabia’s Vision 2030 strategy advances, the largest medical device market in the Middle East is undergoing a deep regulatory upgrade. The Saudi Food and Drug Authority (SFDA) issued a series of new rules in early 2026, from electronic submission to risk classification. This article systematically sets out the latest requirements and practical points for SFDA medical device registration in 2026, helping Chinese medical device companies understand the market access pathway and enter this promising Middle Eastern market efficiently and compliantly.

2026 is seen in the industry as a key turning point for Saudi medical device regulation. The SFDA has carried out a comprehensive upgrade in two areas:

1. Full implementation of electronic submission: all Medical Device Marketing Authorization (MDMA) applications must be submitted through the SFDA’s unified electronic system (GHAD). Manufacturers and local authorized representatives (AR) must complete account registration, company qualification verification and upload of all technical documentation in the system before registration can begin.

SFDA GHAD electronic portal:

https://www.sfda.gov.sa/

2. Upgraded technical documentation requirements: technical documents in Arabic following SFDA templates are explicitly required; all key documents not in Arabic must be accompanied by certified English translations, and labels and IFUs must be prepared in both languages.

The SFDA classifies medical devices into four risk classes, A, B, C and D. The classification directly affects the documents required, review time and registration fees.

Classified by invasiveness, active/implantable status, contact site and duration of use:

Class A: non-invasive/low risk (e.g. non-invasive general consumables, reusable surgical instruments)
Class B: short-term invasive, non-invasive devices for storing fluids, basic active therapeutic devices
Class C: long-term invasive devices, ionizing radiation, devices incorporating medicinal substances
Class D: implants in the central nervous/circulatory system, devices containing biological materials, high exposure to nanomaterials, implantable contraceptives

2. In vitro diagnostic medical devices (IVD)

Classified by intended testing purpose and risk impact:

Class A: general laboratory consumables, specimen containers
Class B: routine test reagents
Class C: self-tests (except pregnancy/glucose/cholesterol), cancer/genetic tests, companion diagnostics
Class D: blood transfusion/transplant screening, tests for life-threatening infectious diseases

Practical tips: (1) incorrect classification is one of the most frequent reasons for MDMA applications being rejected. Before formally applying, confirm the product’s risk class according to the SFDA classification guidance MDS-G008, and if necessary submit a classification request to the SFDA for official confirmation. (2) Contact EVERBIZ for a free copy of the MDS-G008 classification guidance.

1. Local authorized representative (AR/LAR):

Mandatory – no way around it

Under Saudi regulations, all overseas medical device manufacturers entering the Saudi market must designate a legal entity located in Saudi Arabia as their local Authorized Representative (AR/LAR). The AR is not only the official communication bridge between the SFDA and the manufacturer but also bears significant legal responsibilities.

The AR’s core responsibilities include:

Submitting MDMA applications in GHAD on the manufacturer’s behalf and maintaining the account;
Keeping a copy of the manufacturer’s technical documentation available for the SFDA on request;
Assisting with post-market matters, including adverse event reporting, coordination of on-site audits and recall notifications;
Ensuring the manufacturer continues to comply with updates to Saudi regulations.

2. Technical documentation that is both complete and properly structured

Technical documentation is the most time-consuming part of MDMA registration and the main reason applications fail. The SFDA’s Requirements for Medical Devices Marketing Authorization (MDS-REQ-001-V6.0) set mandatory technical documentation requirements.

Annex 3, general medical devices (8 modules):

(1) Product description and specifications, rationale for classification;

(2) Labels/IFU/promotional materials;

(3) Design and manufacturing information (drawings, processes, suppliers);

(4) Evidence of conformity with safety and performance requirements;

(5) Benefit-risk analysis + risk management documentation;

(6) Product verification and clinical data;

(7) Post-market surveillance (PMS) plan;

(8) Periodic safety update report (PSUR).

Annex 4, IVD medical devices:

(1) Test principle, analytical/clinical performance reports;

(2) Stability (shelf life/in use/transport);

(3) Software validation, safety of materials of biological origin;

(4) Post-market performance follow-up (PMPF).

Clinical and performance evaluation:

(1) General devices: clinical evaluation + post-market clinical follow-up (PMCF), which may be simplified using data from equivalent devices;

(2) IVDs: scientific validity + analytical performance + clinical performance evaluation, with post-market performance follow-up (PMPF);

(3) High-risk devices must submit clinical investigation protocols + reports.

SFDA (Saudi Food and Drug Authority) medical device registration fees vary according to the device class, type of registration and specific process. Fees generally fall into the following categories:

Registration application fee: usually a one-off fee based on device class and risk; higher-risk devices pay more.
Evaluation and review fees: vary by device; high-risk devices usually require more review work.
Annual fees: some devices also require annual fees, mainly for market maintenance and compliance management.
Additional fees: laboratory testing or certification body certification may involve extra costs.

These fees change with policy adjustments, so we recommend obtaining the latest fee information from the SFDA’s official website or a local consultancy.

1. Challenges companies often face in SFDA registration:

Language barriers: all key non-Arabic documents must be translated into Arabic, and labels and IFUs must be bilingual. We recommend working with professional translation agencies early to ensure quality.
Incorrect classification: wrong risk classification can lead to rejection or delays. Confirm classification according to the MDS-G42 guidance and, where necessary, apply to the SFDA for an official classification decision.
Insufficient clinical data: for high-risk devices (Class C/D), insufficient clinical evidence may cause registration to fail or be seriously delayed. Plan the clinical evaluation route early and make full use of internationally recognized clinical study data.
Poor choice of authorized representative: choosing an AR lacking medical device experience or resources may cause poor communication and registration delays.

2. For companies exporting medical devices to Saudi Arabia

EVERBIZ provides a full range of services:

Training on Saudi medical device regulations;
Saudi medical device classification consulting;
Saudi local authorized representative services;
Preparation of Saudi technical documentation;
MDMA application and registration services;
Coaching on corrections during MDMA review;
Saudi MDMA GHTF certificate renewal services;
Product testing services;
Technical services for post-market surveillance;
Saudi UDI application services.

Points to note:

Used medical devices cannot be exported to Saudi Arabia.
The standard frequency is 60 Hz, a uniform national requirement.
The same product from the same manufacturer can have only one AR in Saudi Arabia.
The AR agreement must be valid for longer than the SFDA certificate.
If an applicant fails to respond after three rounds of review, the SFDA will reject the application without refunding fees.

The SFDA’s Requirements for Licensing Medical Device Establishments (MDS-REQ 9) set out the licensing conditions, obligations and procedures that 10 types of medical device establishments must follow before doing business in Saudi Arabia.

1. The 10 types of establishments with a legal entity in Saudi Arabia:

(1) Local manufacturers;

(2) Authorized representatives (of overseas manufacturers);

(3) Importers and distributors;

(4) Warehouses;

(5) Clinical trial and validation service providers;

(6) Testing laboratories;

(7) Conformity assessment and quality management system service providers;

(8) Quality assurance service providers for radiation-emitting equipment;

(9) Technical consulting service providers;

(10) Medical device maintenance service providers.

2. General requirements for all types of establishments

Legal entity: must have a legally registered presence in Saudi Arabia. System registration: in the SFDA’s GHAD
Quality system: manufacturers, importers and distributors of Class A and B devices must hold ISO 13485 certification.
Fees: license fees paid according to Annex 2.
Record keeping: maintain a database and keep all relevant data and documents for at least 5 years.
Prompt response: documents or information requested by the SFDA must be provided within 10 days.
Marketing authorization: all medical devices in circulation must hold an SFDA marketing authorization (MDMA).
Advertising approval: advertising and promotion of medical devices require prior SFDA approval.
Transport and storage: follow manufacturer instructions and SFDA transport and storage requirements (MDS-REQ 12).
Change notification: any change to license information must be notified to the SFDA within 10 days.
Renewal: renewal applications can be submitted 60 days before the license expires.
No unauthorized sharing of documents: SFDA-related documents may not be shared with any party without the SFDA’s written approval.

3. Specific requirements for each type of establishment

If you plan to do medical device business in Saudi Arabia, we recommend the following steps:

Confirm the establishment type: which of the 10 types above you belong to.
Meet the general requirements: register in GHAD, prepare an ISO 13485 certificate and establish a quality system.
Meet the specific requirements: prepare staff qualifications, contracts, facilities, etc. for your establishment type.
Prepare fees: calculate the annual license fee according to Annex 2 of MDS-REQ 9.
Submit the application: via the GHAD platform.
Ongoing compliance: after licensing, continue to meet reporting, change notification, post-market surveillance and other obligations.

Conclusion

With extensive practical experience in quality systems and product registration, EVERBIZ is ready to support your medical devices’ entry into Vietnam, Singapore, Thailand, Saudi Arabia and other markets.

Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.

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EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).

Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany

Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria

Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong

Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520