Circulation Definition and MDMA Scope under Saudi Law

1. Key takeaways

Article 1 of M/54 defines Circulation of Medical Devices and Supplies as the provision of devices or supplies with or without payment, whether by distribution or by use; Marketing Authorization is the document issued by SFDA permitting a device to circulate on the market. The direct conclusion of this pair of definitions is that charging or not charging does not affect the trigger of the MDMA obligation: exhibition samples, donations and research use are not automatically out of scope merely because no money changes hands. The real exit lies in the exemption list — devices intended for clinical trials, research, education, demonstration, training, custom purposes or national emergency use may be exempt from the MDMA (MDS-G011 V2.0 Part 3 Note, see MDS-REQ5). But two restrictions apply alongside: importing semi-finished medical devices for production purposes still requires an import permit, and serious adverse events or device deficiencies associated with clinical trials must still meet the reporting requirements of MDS-REQ 2 V4.1.

• Circulation is defined as provision with or without payment, whether by distribution or by use, so free-of-charge scenarios remain in scope.
• Devices for clinical trials, research, education, demonstration, training, custom purposes or national emergency use may be exempt from the MDMA (MDS-G011 V2.0 Part 3 Note, see MDS-REQ5).
• Importing semi-finished devices for production purposes still requires an import permit.
• Serious adverse events or device deficiencies associated with clinical trials must be reported under MDS-REQ 2 V4.1 (dated 26 December 2022).
• Resale, lending or donation of second-hand devices falls within Scope item 6 of MDS-REQ 11 V2.0.

2. Legal basis

The table below traces the definition of Circulation and the exemptions and residual duties that surround it.

3. Expert insights

Why Saudi Arabia writes without payment into the definition of Circulation

Placing payment and non-payment side by side closes a common evasion route: a company delivers unapproved products into hospitals under the banner of donation, exhibition samples or trial use, and once the products are used clinically argues that no sale took place and the regulation is not engaged. The wording of M/54 defeats that argument — once a provision takes place, whether or not payment was received, and whether the form is distribution or use, Circulation is constituted. Compared with the EU MDR, making available on the market stresses supply in the course of a commercial activity; although interpretive documents cover free-of-charge provision, the statutory wording is less blunt than the Saudi one. The US FDA uses commercial distribution as its trigger and regulates pure donations relatively lightly. China’s NMPA centres on placing on the market, with separate ethics and filing channels for donation and research use of unapproved products. The Saudi approach is closer to act-based triggering than transaction-based triggering, which is a real difference for Chinese manufacturers accustomed to using donations for market entry.

Exemption is not automatic: beyond the list, the import stage still counts

The exemption list in Part 3 Note of MDS-G011 V2.0 covers clinical trials, research, education, demonstration, training, custom purposes and national emergency use. GRZAN stresses two points. First, what is exempted is the MDMA, not every formality — importing semi-finished medical devices for production purposes still requires an import permit (see MDS-REQ5), and documents must still be produced at customs clearance. Second, although clinical trials are exempt from the MDMA, they trigger another set of duties: MDS-REQ 2 V4.1 requires serious adverse events or device deficiencies associated with clinical trials to be reported as prescribed, and MDS-REQ 11 V2.0 also brings clinical-trial-related serious adverse events into the PMS system. In other words, the exemption route merely swaps the duty from product registration to process supervision; the workload does not fall to zero. The resale, lending or donation of second-hand devices is likewise written into Scope item 6 of MDS-REQ 11 V2.0, echoing the broad definition of Circulation.

The practical impact on Chinese manufacturers: bring non-sales scenarios into the compliance ledger

The scenarios most easily missed fall into four groups: samples left with hospitals for trial at exhibitions, demonstration and standby units sold with equipment, donated machines in academic activities, and repair replacement parts sent across borders. Under the definition of Circulation, all of these constitute provision. GRZAN’s practice is to require clients to keep a non-sales circulation ledger, recording item by item the product name, quantity, recipient, purpose, the basis (the exemption provision or an MDMA already held), and the corresponding approval or filing document number. This ledger can be produced directly in SFDA inspections and internal audits. Note also the definition of License — a document issued by SFDA permitting the holder to carry out any activity governed by the law. It is a separate matter from the MDMA: holding a product authorisation does not mean holding the qualification to carry out distribution or import activity, which requires the MDEL (Medical Devices Establishment License).

The full boundary of the exemption list is examined at https://www.grzan.cn/regulations/saudi/mdma-exemptions-and-special-use-19 , and the logic of import clearance at https://www.grzan.cn/regulations/saudi/import-clearance-and-shipment-permit-36 .

4. Practical recommendations

• Establish a non-sales circulation ledger recording item by item the product name, quantity, recipient, purpose, the basis provision and the document number, covering exhibition samples, donations, trial units, demonstration units and repair replacements.
• Before using an exemption, check the exempted purpose list of MDS-G011 V2.0 Part 3 Note item by item and confirm the use genuinely falls within it (clinical trials, research, education, demonstration, training, custom purposes or national emergency use).
• Download the current version of MDS-REQ5 and verify the specific provisions on import and MDMA exemption (practical estimate); do not judge customs clearance from experience.
• Where semi-finished devices are imported for production purposes, apply for the import permit early and keep it separate from the MDMA exemption.
• Establish reporting procedures for serious adverse events and device deficiencies in parallel with every clinical trial project, executed under MDS-REQ 2 V4.1.
• Bring the resale, lending or donation of second-hand devices into the PMS procedures, with written records maintained under Scope item 6 of MDS-REQ 11 V2.0.
• Distinguish the MDMA from the MDEL: a product authorisation is not a business qualification, and distribution and import require the establishment licence separately.
• Train marketing, sales and after-sales teams on the broad definition of Circulation, so that free-of-charge provision is never used to bypass compliance approval.

5. Verification checklist

• □ Non-sales circulation ledger established and covering all non-sales scenarios
• □ Every non-sales provision traceable to an exemption provision or an MDMA already held
• □ Current version of MDS-REQ5 downloaded and the import and exemption provisions verified (practical estimate)
• □ Import permit for semi-finished devices applied for as needed
• □ Reporting procedures for serious adverse events and device deficiencies established for clinical trial projects
• □ Resale, lending and donation of second-hand devices incorporated into the PMS procedures
• □ The respective scopes of the MDMA and the MDEL clearly distinguished in internal documents
• □ Marketing, sales and after-sales teams trained on the Circulation definition

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 manages SFDA medical device marketing authorisations and Saudi Authorized Representative arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com