MDS-REQ 11 Post-Market Surveillance: NCMDR and Saudi Vigilance Roles

1. Key takeaways

The single mandatory source for post-market surveillance in Saudi Arabia is MDS-REQ 11 V2.0, formally the Requirements for Post-Market Surveillance of Medical Devices, document code MDS-REQ-011-V2/230323, version date 2023-03-23. It sits under the Law of Medical Devices and Supplies, Royal Decree No. M/54, Articles (14), (16), (20), (28), (30), (31), and the Implementing Regulation issued by SFDA Board Resolution No. (3-29-1443), Articles (10/29), (10/30), (14/1), (16/1), (16/2), (20/2), (20/5), (28/1), (28/2), (30/1), (30/2), (31/1). The document divides post-market obligations into eight scope items, and the duty holders are not limited to manufacturers: authorised representatives, importers, distributors and healthcare facilities each have defined positions. Reporting runs through three channels: NCMDR, Saudi Vigilance, and the call centre 19999. Healthcare facilities must appoint an NCMDR liaison officer; manufacturers, authorised representatives, importers and distributors must appoint a designated SFDA contact person. For Chinese manufacturers holding an MDMA, these obligations run continuously from the first day the device is placed on the market and are not suspended by a zero-incident year.

• MDS-REQ 11 V2.0 is the mandatory baseline for all post-market obligations in Saudi Arabia.
• Eight scope items form a closed loop from incident reporting to end-of-life destruction.
• Three reporting channels: NCMDR, Saudi Vigilance and call centre 19999.
• Two separate appointment lines: NCMDR liaison officers for healthcare facilities, SFDA contact persons for supply-chain parties.
• Written procedures and a traceability system are auditable hard requirements, not internal preferences.

2. Legal basis

The obligations in this article rest on one dedicated post-market surveillance requirement and its enabling provisions in the parent law and the implementing regulation, supplemented by the clinical trial and establishment licensing requirements that connect reporting and licensing responsibilities.

3. Expert insights

1. The eight scope items are one chain, not eight isolated lists. The eight scope items of MDS-REQ 11 are: reporting and investigation of adverse events and complaints; reporting of non-complying medical devices; safety alerts and FSCA; appointment of NCMDR liaison officers; reprocessing of medical devices; resale, lending or donation of second-hand devices; after-sales and maintenance services; and destruction of waste medical devices. The eight items are arranged in the order of the device life cycle, forming a closed loop from something going wrong to final disposal. What Chinese manufacturers most easily miss is the second half: reprocessing, second-hand device circulation and terminal destruction. Under Law M/54 Article 1, reprocessing is defined as the safe re-use procedures applied to used devices (cleaning, disinfection, sterilisation, testing and restoration of technical function), a statutory issue whenever single-use devices are reprocessed; and the resale, lending or donation of second-hand devices is listed as a separate obligation, which means gratuitous donation does not fall outside regulation. Treating the second half as the customer’s own business is the most common compliance gap observed in Saudi projects.

2. The two appointment lines belong to two sets of duty holders and cannot substitute for each other. The document pairs responsible persons in two categories: healthcare facilities must appoint an NCMDR liaison officer, while manufacturers, authorised representatives, importers and distributors must appoint a designated SFDA contact person. The former faces clinical-side reporting; the latter faces supply-chain traceability and cooperation with inspections. A foreign manufacturer cannot discharge the second line on its own and can only rely on the local authorised representative, which directly determines that the AR agreement must state the post-market cooperation clauses: receiving SFDA enquiries, organising traceability, and submitting investigation reports. If the AR is contracted only as a filing agent, then once an incident occurs the manufacturer has legally completed the report while operationally nobody executes it. When GRZAN reviews AR agreements, it checks this clause as a standalone item.

3. Written procedures and a traceability system are two hard requirements that can be inspected. The general requirements of MDS-REQ 11 state clearly that a traceability system must be established to record all supply and distribution information; that the procedures for following up incidents and adverse events must be documented in writing; and that medical devices must be traceable at the request of the SFDA. These sentences are the direct objects of verification during inspections: inspectors do not accept verbal assurances, they request procedure documents and distribution records. Compared with the PMS plan and technical documentation update obligations of manufacturers under the EU MDR, the Saudi drafting leans towards operational trace evidence: it places traceability capability and written procedures on the same footing as reporting timelines. The practical implication for Chinese manufacturers is that PMS system documents need to be signed off before the first shipment leaves, not patched together after the first complaint arrives.

The tiering method for the three reporting timeframes is described at https://www.grzan.cn/regulations/saudi/ncmdr-adverse-event-reporting-timelines-42 , and the deadline logic for investigation and final reports at https://www.grzan.cn/regulations/saudi/incident-investigation-and-final-report-deadlines-43 .

4. Practical recommendations

• Map each of the eight scope items of MDS-REQ 11 to an internal responsible role and produce a Saudi post-market obligation responsibility matrix naming a primary and a backup owner for every item.
• Write post-market cooperation clauses into the AR agreement: receiving SFDA and NCMDR enquiries, organising traceability, answering follow-up contacts within 5 days, and submitting investigation reports on behalf of the manufacturer.
• Document the adverse event and complaint follow-up procedure in writing, covering at least intake registration, initial assessment, timeframe tiering, report drafting and archiving, and retain the signed version.
• Build a supply and distribution traceability ledger with fields covering at least batch or serial number, UDI-DI, consignee name, quantity and date, so that SFDA traceability requests can be answered.
• For reprocessing and second-hand device circulation, include prohibitive clauses and liability for breach in sales contracts to prevent downstream conduct from rebounding onto the licence holder.
• Enter call centre 19999 and the Saudi Vigilance channel into the emergency contact page of the quality manual, and run annual training for the relevant roles with records retained.
• When working with healthcare facility customers in Saudi Arabia, confirm whether they have appointed an NCMDR liaison officer, and remind those that have not of their statutory duty.

5. Verification checklist

• □ The current version of MDS-REQ 11 (V2.0 / 2023-03-23) has been obtained and archived
• □ The eight scope items have been mapped one by one to internal responsible roles
• □ The AR agreement contains post-market cooperation and the 5-day reply clause
• □ The adverse event and complaint follow-up procedure has been documented and signed into force
• □ The supply and distribution traceability system is live and can export a complete ledger
• □ Appointment of the NCMDR liaison officer on the healthcare facility side has been confirmed
• □ The three reporting channels (NCMDR, Saudi Vigilance, 19999) are entered in the emergency contact page
• □ Prohibitive contract clauses on reprocessing and second-hand device circulation are deployed
• □ The disposal process for waste medical devices has been confirmed with the local partner

Regulatory information verified as of October 29, 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 adverse event reporting and recall coordination with the SFDA National Center, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com