Saudi FDA medical device bundling guidance MDS-G28 was published on May 5, 2026. It explains when multiple medical devices may be grouped within one Medical Devices Marketing Authorization (MDMA) application and when separate applications may be required.
Medical Device Families
Medical devices may be grouped as a family within a single MDMA application when they meet the criteria established by SFDA. These include:
- The same legal manufacturer
- The same intended use or purpose
- The same risk class
- The same GMDN code definition, when available
- A common physical design, construction material, and manufacturing process
For a medical device family, the guidance limits a single application to a maximum of five technical files and 50 medical-device items.
Medical Device Systems
Devices may be grouped as a system when they have the same legal manufacturer and are intended to be used together to achieve a common intended purpose.
The system components must be linked through the supporting technical documentation, which may include labels, instructions for use, brochures, catalogues, and clinical-evaluation files.
- Only one medical device system may be included per application.
- If system components have different risk classes, the highest risk class applies.
- An application may include a maximum of five technical files.
- The system may include no more than 50 items, including accessories.
Other Product Groupings
MDS-G28 also provides specific bundling criteria for procedure packs, surgical instrument sets, and in vitro diagnostic devices.
For IVDs, relevant considerations include the legal manufacturer, risk class, intended use, principle of operation, and the applicable IVD grouping described in the guidance.
The guidance also notes that a standalone product generally cannot be bundled with a set or kit in the same application simply because the product is a component of that set or kit.
Saudi FDA Medical Device Bundling: What Manufacturers Should Consider
Manufacturers should review their Saudi Arabia registration portfolios to determine whether related products satisfy the criteria for a family, system, procedure pack, surgical instrument set, or eligible IVD grouping.
Before combining products within one application, companies should verify the legal manufacturer, intended use, risk classification, GMDN codes, product relationships, technical-documentation structure, and the applicable limits on technical files and individual items.
RJR can help manufacturers evaluate Saudi FDA medical device bundling options, document the applicable grouping rationale, and prepare an appropriate MDMA submission for Saudi Arabia. Start a conversation with RJR.
Source: Saudi Food and Drug Authority Guidelines — Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application (MDS-G28), published May 5, 2026; document version MDS-G-028-V1/260503.