Saudi Certificate of Free Sale

1. Key takeaways

The Certificate of Free Sale (CFS) has an official definition in Article 1 of Law M/54: a document issued by the SFDA certifying that the manufacturer is registered in Saudi Arabia and that the device intended for export has received marketing authorization. This definition fixes the preconditions: only with the manufacturer’s registration and a valid MDMA does a CFS become available. Procedurally, the CFS application is tied to MDMA status; MDMA validity follows the issue and expiry dates on the certificate, with public sources giving both a 3-year and a 5-year reading (practical estimate), and renewal usually filed at least 90 days before expiry (practical estimate). Whether the CFS itself carries a fee, and at what rate, follows invoices from the GHAD portal or the SFDA billing system (practical estimate). GRZAN positions the CFS as a second monetization of registration assets: Saudi compliance investment can be reused in Gulf and other markets.

• The CFS certifies two facts: manufacturer registration in Saudi Arabia and marketing authorization for the exported device.
• The CFS is derivative of MDMA status; maintaining MDMA validity maintains CFS availability.
• MDMA validity readings of 3 and 5 years circulate (practical estimate); the certificate dates prevail.
• Whether the CFS carries a fee is per GHAD invoices (practical estimate), budgeted with 15% VAT.
• Acceptance of a Saudi CFS varies by destination country and must be verified case by case.

2. Legal basis

The table below lists the instruments cited for the CFS. Items marked as a practical estimate are pending verification against the GHAD portal and billing system.

3. Expert insights

1. The official CFS definition hides two preconditions. Article 1 of Law M/54 defines the CFS as a document certifying that the manufacturer is registered in Saudi Arabia and the device intended for export has received marketing authorization. Split open, two conditions: the manufacturer must hold a registered identity in Saudi Arabia, and the specific device a valid MDMA. Missing either, no CFS can be issued. For Chinese manufacturers: the CFS is not a standalone certificate but a derivative proof of MDMA status, so maintaining MDMA validity is maintaining CFS availability. MDMA validity follows the certificate dates, with 3-year and 5-year readings circulating (practical estimate), constrained by the expiry of supporting certificates such as ISO 13485, so the granted term may be shorter than the statutory ceiling.

2. Issued in the manufacturer’s name determines consistency between CFS and MDMA. Part 3 of MDS-G011 states the SFDA issues the MDMA certificate in the manufacturer’s name. Three consequences for the CFS: the manufacturer information on it must align exactly with the MDMA, the business licence and the ISO 13485 certificate, since a single character of difference can be questioned by the destination authority; changing the AR does not affect the basis for issuing the CFS, since the rights holder is the manufacturer; and if the legal manufacturer entity changes, the MDMA is handled as a major change (possibly at the full fee, practical estimate), breaking CFS continuity. GRZAN recommends a certificate chain health check before applying for a CFS: MDMA, listing number, manufacturer name and address, device models and UDI-DI data checked item by item.

3. The CFS’s value lies in third-country access, but destination requirements differ. The core use of the CFS is to prove to a third-country authority that the product is legally sold in the country of origin or another stringent market. In the Gulf and parts of the Middle East and Africa, Saudi approval carries weight; but some regulators require a country-of-origin or reference-country CFS, and acceptance of Saudi Arabia must be confirmed country by country (a practical estimate, to be verified with the destination authority or its local agent). The CFS also usually only certifies free sale and does not replace the destination country’s registration procedure. For companies approved via the reliance pathway (MDS-G030 V1.0), reuse of the argumentation in third countries needs case-by-case confirmation; reliance solves the Saudi entry, not global portability.

4. Scheduling and cost: make the CFS a routine post-registration action. No SFDA official document directly confirms the CFS processing period or fees (practical estimate, per GHAD billing and current requirements), but its dependence on valid MDMA status is certain: MDMA renewal is usually filed at least 90 days before expiry (practical estimate), and if the CFS is planned to support a third-country filing at a given time, confirm the MDMA remains valid then. GRZAN puts the CFS application into the annual compliance calendar, batched with MDMA renewal, AR licence renewal (practical estimate SAR 2,600 per contract per year plus 15% VAT) and Saudi-DI data review, reducing repeated file retrieval costs.

For MDMA validity and renewal, see https://www.grzan.cn/regulations/saudi/mdma-validity-and-renewal-20 ; for AR change effects on the certificate holder, see https://www.grzan.cn/regulations/saudi/authorized-representative-transfer-and-mdma-change-33 .

4. Practical recommendations

• Confirm the preconditions first: check that the device holds a valid MDMA and that the manufacturer’s registered identity in Saudi Arabia is in force.
• Run the certificate chain health check: compare MDMA, listing number, manufacturer name and address, device models and UDI-DI data item by item for consistency with the CFS application.
• Schedule early: put the CFS application in the same batch as MDMA renewal (filed 90 days before expiry, practical estimate) to avoid a gap from certificate expiry.
• Verify acceptance country by country: confirm with the destination authority or its local agent whether a Saudi CFS is accepted, and whether a country-of-origin CFS is required.
• State the CFS boundary: explain externally that the CFS certifies free sale and does not replace the destination country’s registration procedure.
• Divide duties with the AR: the Saudi AR assists with GHAD submission and progress follow-up; the manufacturer provides the model list and destination country information.
• Fees per the billing statement: whether the CFS is charged and at what rate follows GHAD invoices (practical estimate), with a VAT-inclusive 15% allowance reserved in advance.
• Archive and reuse: add the CFS scan and application number to the registration dossier for later third-country filings; direct questions to call centre 19999 and md.rs@sfda.gov.sa.

5. Verification checklist

• □ MDMA for the device intended for export within validity, issue and expiry dates checked
• □ Manufacturer’s Saudi registration in force, name and address matching the licence and ISO 13485 certificate
• □ Marketing Authorization Number and Medical Device National Listing Number recorded
• □ MDMA certificate confirmed as issued in the manufacturer’s name (MDS-G011 Part 3)
• □ Device models and UDI-DI data checked for consistency
• □ Destination country acceptance of the Saudi CFS confirmed with the authority or local agent
• □ CFS application submitted by the AR in GHAD, progress traceable
• □ CFS rate per GHAD billing system invoices (practical estimate, including 15% VAT)
• □ CFS application scheduled in the same batch as MDMA renewal (90 days ahead, practical estimate)
• □ CFS scan and application number added to the registration dossier

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Saudi Arabian market. Our team coordinates Saudi Authorized Representative arrangements, import licences, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com