Grouping Medical Devices into One Registration Unit under GN-12

1. Key takeaways

Yes, it is allowed. Singapore permits multiple models or variants to be combined into a single registration unit (device listing) for submission, provided the grouping rules are met, thereby significantly reducing the number of registrations, the evaluation fees and the maintenance costs. The grouping rules are set out in GN-12-1 R3, Guidance on Grouping of Medical Devices for Product Registration, General Grouping Criteria (updated June 2026) and GN-12-2 R2, Grouping-Specific (January 2022); at submission, the Annex 2 for GN-17 and GN-18 List of Configurations (October 2026 version) must also be provided.

• Evaluation fees are charged per registration unit, so grouping is the most direct cost-reduction lever in a Singapore project and its benefit lasts the whole product lifecycle, including annual retention fees and change notifications.
• The boundary of grouping is homogeneity: the differences between the models must be small enough for one set of safety and effectiveness evidence to cover them.
• IVDs group on a different logic from general devices, built around the same detection principle, analyte family and platform.
• The configuration list is where the grouping decision lands on paper, and it must be drafted before the CSDT, never after.
• Over-broad grouping carries a real risk: if one model’s evidence is weak, the entire unit can be delayed, not just that model.

2. Legal basis

Grouping for product registration is governed by the two GN-12 guidance documents, while the submission format follows GN-17 R5 and GN-18 R5 under the ASEAN CSDT structure. The configuration list in Annex 2 accompanies the submission and records how the grouped unit is composed. The table below consolidates the sources.

3. Expert insights

Insight one: grouping is the most direct cost-reduction instrument in a Singapore project, and it is one-off.

The evaluation fee is charged per registration unit. Taking the Class B Full route at SGD 3,900 as an example: if 10 models are split into 10 units, the evaluation fee is 39,000 SGD; if they are lawfully combined into 1 unit, the fee is 3,900 SGD. The grouping decision is made at project initiation, and its benefit persists across the entire product lifecycle, including the subsequent annual retention fees and change notifications, which are likewise charged per unit.

Insight two: the boundary of grouping is that the products within one unit must be sufficiently homogeneous.

Grouping is not packaging a product line. The general criteria of GN-12-1 R3 and the specific criteria of GN-12-2 R2 answer, in essence, the same question: are the differences between these models small enough that a single set of safety and effectiveness evidence can cover them? Substantive differences in intended use, technological principle, key performance, sterilisation method or material contact characteristics will usually break the grouping. The test is applied to the evidence, not to marketing convenience: a shared brand name or catalogue family confers no eligibility to group, and every claim of homogeneity must be traceable back to the technical documentation that supports it.

Insight three: the grouping logic for IVDs differs from that for general devices.

IVDs follow GN-18 R5, and their grouping typically revolves around the same detection principle plus the same analyte family plus the same platform; general devices (GN-17 R5) focus more on the continuity of structure, materials and performance parameters. Applying the general-device grouping logic to IVDs is one of the problems we most frequently find when reviewing client documents.

Insight four: the configuration list is the execution anchor of grouping.

The Annex 2 List of Configurations is the document that puts the grouping decision on paper. In our projects we require clients to fix the grouping strategy first, then fill in the configuration list, and finally compile the CSDT. Reversing the order produces a technical dossier that contradicts the configuration list, which triggers supplementary requests. Each supplementary request adds stop-clock time to the evaluation and erodes the very fee savings the grouping was meant to secure, so the discipline of ordering these documents correctly is itself part of the cost case.

Insight five: the risk of grouping too broadly is that the whole unit gets stuck.

This is the other side that needs a warning: once combined into one unit, if the technical evidence for any one model is insufficient, the entire unit may be delayed, not only that model. For flagship models that are sensitive to time to market, registering separately is sometimes the safer choice.

4. Practical recommendations

• Finalise the grouping strategy at project initiation: complete it before CSDT compilation begins.
• Group by evidence coverage, not by market classification: whether one set of evidence can cover the models is the only substantive standard.
• Assess separately versus combined for flagship models: for time-sensitive models, prefer separate registration to avoid being dragged down by other models in the group.
• Maintain the configuration list and the CSDT with one team: to avoid inconsistency between the two documents.
• Reassess the grouping when adding models: whether a new model can join an existing unit must be re-judged, usually handled through a change notification (GN-21).

5. Verification checklist

• □ Grouping feasibility has been assessed under the GN-12-1 R3 general criteria
• □ Whether the GN-12-2 R2 specific criteria apply has been checked
• □ IVDs have been assessed separately under the GN-18 R5 grouping logic
• □ The grouping strategy has been fixed before the CSDT compilation
• □ The Annex 2 configuration list has been submitted and is consistent with the CSDT
• □ Whether flagship models need separate registration has been assessed
• □ The change path for later model additions has been planned (GN-21)

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Singapore. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with HSA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com