Medical Device Registration in Saudi Arabia (SFDA Approval)
Saudi Arabia Medical Device Regulations - Overview
The Saudi Food and Drug Authority (SFDA) regulates the sale and distribution of medical devices and IVDs in Saudi Arabia. To market medical devices (including IVDs) in the Kingdom of Saudi Arabia (KSA), a Medical Device Market Authorization (MDMA) from the SFDA is necessary. The SFDA completely analyses MDMA applications, so prepare ahead of time to secure quick approval. Operon Strategist can entirely assist with your medical device registration in the Kingdom of Saudi Arabia with the help of our expert medical device consultants in Riyadh.
The medical device manufacturers who are not based in KSA need to appoint an Authorized Representative (AR). These representatives will act as a liaison between you and SFDA, as per the MDIR. The Authorized Representative should obtain an AR license which is renewable on an annual basis to legally represent you in KSA.
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Medical Device Registration And Approvals in Saudi Arabia
Medical Device Marketing Authorization (MDMA)
To market a device in KSA, all other classifications of devices require medical device approvals known as Medical Device Marketing Authorization (MDMA). The SFDA Medical Device registration schedule for MDMA approval via this process usually takes 35 days, and licenses are valid for the original license validity term or 3 years for an undefined original license duration.
Medical Devices Registration Process
We can summarize the medical device registration and approval process in the following few steps:
- Appoint a Saudi authorized representative (AR)
Through a knowledgeable AR, legal manufacturers can have advanced regulatory support with the ever-changing SFDA regulations. Even if there was an appointed AR before, manufacturers can transfer to a new AR and transfer all old MDMA approvals. Contact us for more details. - Prepare the technical file for MDMA submission
Companies must do a thorough gap analysis on the available file against the SFDA requirements in order to be ready for MDMA submission. Identifying the gaps is essential for determining the required research, reports, or post-approval commitments, such as PMCF in Saudi Arabia. Rejecting an application costs time and faces substantial SFDA expenses. - MDMA submission
The SFDA will not accept a registration file that has clearly been submitted by a non-specialized regulatory professional. The SFDA’s reply will not specify the gaps and what needs to be done; instead, the applicant will be asked to resubmit according to the applicable rules. If it was properly prepared, however, the applicant should expect technical inquiries similar to those received from notified bodies. The applicants will be given a limited number of waivers from responding to questions as well as a time frame. - MDMA approval
Once granted by SFDA, the owner of the license, which is always the legal manufacturer, can ship the goods to Saudi with all necessary SFDA requirements for shipment clearance at Saudi ports.
SFDA Registration Documents List:
- Application Form
- Authorized Representative
- Technical File
- Conformity Assessment Report
- Medical Device Market Authorization Certificate
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How Operon Strategist Can Help You with Regulatory Service
Whether you are a new or existing manufacturer, our skilled team at Operon Strategist ensures effective regulatory support throughout:
- Providing regulatory process help
- Providing direction to QMS installations
- Assisting clients with product and company design and development, as well as GAP analysis.
- Assisting with technical file creation for submission.
- Respond to and submit SFDA queries properly.
- Follow up until regulatory approval is obtained.
Discover the key to successful medical device registration in Saudi Arabia with Operon Strategist. As your dedicated consultants, we possess in-depth knowledge of the Saudi Arabian regulatory landscape, ensuring swift and efficient market approval for your medical devices. Provides expert services for QMS like ISO 13485 certification. Let’s navigate the path to success together! Contact us for more details.
Operon Strategist Provides SFDA Registration Consultancy Services in Worldwide
FAQs
Is a CE Mark Required for Medical Devices in Saudi Arabia?
In Saudi Arabia, CE certification is required for high-risk medical devices that could pose significant safety or health risks to users. These devices must be certified by a notified body to ensure compliance with stringent safety and performance standards.
How Long Does It Take to Register a Medical Device in Saudi Arabia?
The Saudi Food and Drug Authority (SFDA) generally takes 30 to 60 days to review initial medical device registration submissions. However, the timeline may vary depending on the completeness of the documentation and the complexity of the device.
What Are the SFDA Labeling Requirements?
The SFDA labeling requirements mandate that medical device labels include a Unique Device Identifier (UDI) code, expiration date, control or batch number, storage and handling instructions, indications for use, and any other relevant information needed for safe and effective device use. These standards ensure traceability, compliance, and user safety.
Do All Devices Require MDMA Approval?
Yes, all medical devices and in vitro diagnostics (IVDs) that fall under the definition outlined in Article 1 of the Medical Devices Law must obtain MDMA approval.