MDS-G011 Manufacturing Paths: Full, Branch and Contract Manufacturing

1. Key takeaways

MDS-G011, the Guidance on Manufacturing Paths of Medical Devices, V2.0 (serial number MDS-G-011-V2/250707, version date 2025-07-07), splits in-Kingdom manufacturing into 3 paths. Path 1 is full manufacturing: every step is completed at a single site inside Saudi Arabia. Path 2 is branch manufacturing: some steps are completed at the in-Kingdom site and the rest at another site inside or outside the Kingdom. Path 3 is contract manufacturing: some steps are completed in the Kingdom while the rest are completed by an independent manufacturer located abroad under a contract between the two parties, and the in-Kingdom manufacturer purchases one of the product components from that foreign party. The hard requirements common to all three paths are: manufacturing requires a manufacturer licence issued under MDS-REQ 9; an ISO 13485:2016 certificate issued by an SFDA-recognised conformity assessment body (CAB) is required; and the SFDA issues the MDMA in the manufacturer’s name. The SFDA also offers free technical support: the call centre 19999, the mailbox md.rs@sfda.gov.sa, meetings with the SFDA technical team, and seminars. Regulatory information verified as of 29 October 2026.

• Path 1 full manufacturing, Path 2 branch manufacturing, Path 3 contract manufacturing — defined by where each step is performed.
• All paths require an MDS-REQ 9 manufacturer licence and an SFDA-recognised CAB’s ISO 13485:2016 certificate.
• The SFDA issues the MDMA in the manufacturer’s name.
• Free technical support: call 19999, md.rs@sfda.gov.sa, technical-team meetings, seminars.

2. Legal basis

The following instruments define the three manufacturing paths, the statutory definitions behind them, and the licence, QMS, import and change-notification obligations that attach to them. Third-party retellings are marked as practical estimates with their verification actions.

3. Expert insights

1. The Manufacturer definition is far wider than intuition suggests

Law M/54 Article 1 contains a sentence Chinese manufacturers most easily overlook: the Manufacturer is the domestic or foreign legal person under whose name a device is designed or manufactured, and manufacture includes refurbishing, assembling, packaging and labelling. This means a Chinese manufacturer that sets up only a final packaging and labelling workshop inside Saudi Arabia is, from the perspective of Saudi law, no longer a warehouse but a manufacturer. The consequences chain together: it must obtain a manufacturer licence, it needs an ISO 13485:2016 certificate covering that activity, and the MDMA will be issued in its name — not in the name of the Chinese parent company. Many companies treat such an arrangement as a shipping point in Saudi Arabia and discover at the MDMA filing that the licence holder is entirely different from what they assumed.

2. The real variable across the three paths is who is written into the MDMA

The difference among the three paths looks superficially like the distribution of steps between the Kingdom and abroad; in substance it is the division of the MDMA holder and the boundary of responsibility. Path 1 is the cleanest: all steps happen at one in-Kingdom site, and who the manufacturer is needs no discussion. Path 2 introduces a second site — possibly another factory within the same group, possibly a foreign factory — and the questions become whether the second site is covered by the QMS and whether it is technically a branch of the same manufacturer or an independent third party. Path 3 is the most complex: the foreign party is an independent manufacturer, the relationship is contractual, and the in-Kingdom party also purchases one of the product components from it, which simultaneously raises the contract arrangement, incoming component inspection, and the import licence for semi-finished products (MDS-REQ 5). MDS-G011’s qualification here is crucial — the SFDA issues the MDMA in the manufacturer’s name; in other words, outsourcing a manufacturing step does not move the MDMA to the foreign manufacturer, and responsibility remains with the in-Kingdom licence holder.

3. Once the path is fixed, every later change goes through MDS-G12

Choosing a path is not a one-off act. Adding a production site, moving a step from abroad into the Kingdom, replacing the foreign contract manufacturer — all constitute changes that must be judged significant or non-significant under MDS-G12 and notified through the corresponding procedure. The common Chinese misstep is to complete process adjustments and supplier switches at home first and synchronise with the SFDA only at the next renewal or the next filing, by which time a record of unnotified changes exists and will be pursued at inspection or renewal. Judging changes before acting, rather than notifying afterwards, is the most valuable sentence in this section. On pairing the quality certificates, see https://www.grzan.cn/regulations/saudi/mdsap-certificate-as-qms-evidence-15 ; a dedicated discussion of change determination is in https://www.grzan.cn/regulations/saudi/significant-and-non-significant-change-46 .

4. Practical recommendations

• Self-check against the Manufacturer definition of Law M/54 first: even if the in-Kingdom footprint is only packaging or labelling, configure the licence and QMS coverage as a manufacturer would require.
• Draw a process map marking the actual execution site and country of every step, and determine from it whether the arrangement is Path 1, 2 or 3.
• Path 3 requires three document sets: the contract with the foreign independent manufacturer, the component purchase and technical agreement, and the semi-finished product import licence materials.
• The ISO 13485:2016 certificate must be issued by an SFDA-recognised CAB, with scope covering the in-Kingdom site’s actual activities.
• Before any site or process change, make the significant/non-significant judgement under MDS-G12 first and form a written conclusion before acting.
• Where SFDA clarification is needed, prefer the official free channels: call centre 19999, md.rs@sfda.gov.sa, and a meeting with the technical team.
• Archive SFDA replies (including call records and email responses) with reference numbers as the basis for answering later queries. GRZAN’s experience is that official email replies carry the strongest evidentiary weight in later inspections, so important questions should go through written channels.

5. Verification checklist

• □ A full process map has been drawn marking the execution site of every step
• □ The applicable path (1 full manufacturing / 2 branch manufacturing / 3 contract manufacturing) has been determined from the map
• □ The judgement on whether the in-Kingdom entity constitutes a Manufacturer is recorded in writing
• □ The manufacturer licence application materials (MDS-REQ 9) are prepared or the licence is held
• □ The ISO 13485:2016 certificate is issued by an SFDA-recognised CAB and its scope covers the in-Kingdom activities and sites
• □ For Path 3, the contract, purchase agreement and semi-finished product import licence materials are complete
• □ Agreement on the MDMA holder entity has been reached within the group and entered in the ledger
• □ The change-determination process is embedded in production change management and cites the current MDS-G12

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 MDMA applications across classes, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzan.com