SFDA Medical Device Registration Consultants - Operon Strategist
Saudi Arabia is rapidly emerging as a major hub for the healthcare and medical device market. For manufacturers aiming to access this growing market, compliance with the SFDA Medical Device Registration process is essential. The Saudi Food and Drug Authority (SFDA) is the national regulatory authority responsible for ensuring the safety, performance, and quality of medical devices and IVDs in Saudi Arabia. It governs all aspects including manufacturing, importation, registration, and post-market surveillance.
What is SFDA Medical Device Registration?
SFDA Medical Device Registration is a mandatory regulatory process that ensures your device complies with the Medical Device Interim Regulations (MDIR) before entering the Saudi Arabian market. Manufacturers must obtain a Medical Device Market Authorization (MDMA) certificate, which confirms that the product has passed SFDA’s Technical File Assessment (TFA) and meets all safety and performance requirements.
Key Updates in SFDA Medical Device Regulations
From January 2022, SFDA discontinued the GHTF-based fast-track route and mandated full technical file assessment for all MDMA applications. This includes low-risk medical devices, which must now be registered via the MDMA pathway using the MDMA-2 form.
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SFDA Medical Device Registration Process
The typical SFDA Medical Device Registration process includes:
Medical Device Classification
Appointment of Authorized Representative (if required)
Technical File Assessment (TFA)
SFDA Query Resolution
Approval and Certificate Issuance
Technical File Requirements for MDMA:
Device description & intended use
Design and manufacturing details
Risk management file
Clinical evaluation report
Biocompatibility data
Post-Market Surveillance (PMS) plan
Periodic Safety Update Report (PSUR)
UDI (Unique Device Identification)
SFDA Medical Device Registration Routes
Low-Risk Devices (Class I – Non-Sterile, Non-Measuring)
- Must be listed in the Medical Device National Registry (MDNR)
Abridged or Direct Route options available
Timeline: ~2 weeks depending on SFDA queries
High-Risk Devices (Class C, D)
Must undergo full MDMA application with TFA
Requires AR agreement and license
Timeline: ~12 weeks for new, ~8 weeks for renewals
SFDA Medical Device Classification
Medical devices in Saudi Arabia are classified according to risk, in line with EU MDR guidelines:
| SFDA Class | Risk Level | Equivalent EU MDR Class |
|---|---|---|
| A | Low | Class I |
| B | Low-Medium | Class IIa |
| C | Medium-High | Class IIb |
| D | High | Class III |
Classification is based on the intended use and technical characteristics of the device. The classification determines the level of documentation and evaluation required for SFDA Medical Device Registration.
Appointing an Authorized Representative (AR)
Foreign manufacturers must appoint a Saudi-based Authorized Representative (AR) who will act as the legal liaison with the SFDA. The AR must hold a valid AR license, which is renewable annually. AR responsibilities include submitting applications, handling regulatory communications, and maintaining technical documentation on behalf of the manufacturer.
From Documentation to Approval – Full SFDA Support by Saudi’s Regulatory Leaders
Why Choose Operon Strategist for SFDA Medical Device Registration?
We provide end-to-end SFDA Medical Device Registration and regulatory consulting services tailored to your business needs. Our expertise includes:
Medical device classification and regulatory pathway selection
Appointment and management of AR services in Saudi Arabia
Preparation of complete Technical File as per SFDA guidelines
Submission and follow-up for MDMA / MDNR applications
Expert response to SFDA queries and deficiency letters
Quality Management System (QMS) guidance and compliance with Saudi regulatory expectations
FAQ'S
What is SFDA medical device registration?
It is the official approval process by the Saudi Food and Drug Authority (SFDA) that allows medical devices to be legally marketed in Saudi Arabia.
What documents are required for SFDA medical device registration?
Key documents include ISO 13485 certificate, device technical file, safety and efficacy data, labeling, and clinical evidence.
How long does SFDA registration take?
The timeline depends on the device class and documentation, usually ranging from a few weeks to several months.
What are the steps involved in SFDA medical device registration?
The steps include device classification, preparation of documents, submission to SFDA, review and clarifications, and final approval.
What is the cost of SFDA medical device registration?
The cost varies by device type and classification. Consulting with Operon Strategist helps get accurate cost estimates.