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 required to legally place medical devices on the Saudi Arabian market. The process is governed by the Medical Devices Law and implementing regulations issued by the Saudi Food and Drug Authority (SFDA).
To commercialize a medical device in Saudi Arabia, manufacturers must obtain a Medical Device Market Authorization (MDMA) certificate. This certification confirms that the device has successfully undergone the SFDA’s Technical File Assessment (TFA) and complies with all applicable safety, quality, and performance requirements.
The MDMA ensures that medical devices supplied in the Kingdom meet regulatory standards designed to protect public health and patient safety.
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Key Updates in SFDA Medical Device Regulations
Effective January 2022, the SFDA implemented significant regulatory changes:
The previous GHTF-based fast-track pathway was discontinued.
All medical devices, regardless of risk classification, are now subject to a full Technical File Assessment (TFA).
Low-risk medical devices are no longer exempt from detailed review and must be registered through the MDMA pathway.
Submission of the MDMA-2 application form is mandatory for all MDMA applications.
These updates reinforce SFDA’s commitment to a more robust and comprehensive regulatory framework, ensuring consistent evaluation standards across all device classes.
Get SFDA Approval from the Best in Saudi Arabia – Fast, Reliable, Compliant
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.