SINGAPORE · MEDICAL DEVICES
Singapore general medical device risk classification: applying GN-13 from intended use to the rules
In Singapore, the risk class of a general medical device starts from the intended purpose for which it will be sold locally. Two products with the same name can fall under different rules if they are used on different wounds, contact different parts of the body, stay in use for different periods or perform different clinical functions. Carrying over an overseas class, or the class of a similar product, can send the registration route, dossier and budget in the wrong direction.(Source: HSA GN-13 R2.1, Section 4)
This article focuses on one question: how a manufacturer can turn its IFU, specifications and model information into a rationale that shows why the device was classified as it was. For an overview of market entry in Singapore (classification, grouping, routes and fees), see MediPass Singapore medical device registration.
Which set of rules applies?
HSA’s current list of guidance documents includes the classification documents below. Determine what kind of product you have before choosing the rules, so that reagents, analysers, software and ordinary hardware are not treated as the same case.(Source: HSA guidance documents for medical devices)
| Product situation | Applicable document (current version) | Points to note |
|---|---|---|
| Not yet clear whether it is a medical device (drug–device borderline, health products, etc.) | GL-06 R2 Medical Devices Product Classification Guide (October 2023) | Settle whether it is a medical device before discussing risk class. |
| General medical device (GMD) | GN-13 R2.1 (September 2018) | GN-13 does not cover devices for the in vitro examination of specimens from the human body. |
| In vitro diagnostic device (IVD) | GN-14 R3 (July 2023, effective 24 July 2023) | Seven rules; calibrators, controls and embedded software have their own principles. |
| Software as a medical device (SaMD) and clinical decision support software (CDSS) | GL-07 R2 (July 2025), used with GN-13 | GN-13 deems standalone software an active medical device; GL-07 R2 clarifies when SaMD is Class B under GN-13 Rule 10(i). |
(Source: GN-13 Section 1.3 and p. 12; GN-14 R3; HSA announcement on the GL-07 update)
When marketing materials add diagnostic, therapeutic or disease-monitoring claims, we recommend checking whether those claims change the product’s status or class. Whether the word “medical” appears on the pack is not the test.
Write down the product facts before you classify
GN-13 notes that a device’s risk depends in part on its intended users, its mode of operation and the technologies it uses. Section 2 lists factors including the duration of contact with the body, the degree of invasiveness, whether the device delivers medicinal products or energy to the patient, whether it is intended to have a biological effect, and local versus systemic effects. The table below is a project worksheet built on those factors; it is not an HSA format.(Source: GN-13 Sections 1.2 and 2, pp. 4 and 11)
| Fact to establish | Where to check it | What a gap affects |
|---|---|---|
| Intended purpose and clinical function | Wording in the IFU, labels and specifications | Which rules apply and which use carries the highest risk |
| Intended patients and users | Target population, contraindications, use environment | How outputs or operation affect the patient |
| Body contact and invasiveness | Drawings, use steps, contact materials | Intact skin, injured skin, body orifice or surgically invasive |
| Duration of use | Single-use time, continuous use and replacement pattern | Transient, short-term or long-term use |
| Principle of operation | Power source, signal processing, delivery of medicinal products or energy, control | Whether it is active, and which therapeutic or diagnostic rules and exceptions apply |
| Accessories and model differences | Configuration list, accessory list, model comparison | Whether items need separate classification or further explanation |
Duration follows the GN-13 definitions: transient means continuous use for up to 60 minutes, short-term between 60 minutes and 30 days, and long-term more than 30 days. Continuous use is not broken by a temporary interruption, and accumulated use where one device is immediately replaced by another counts as well. A product labelled “single use, replace as needed” therefore still needs a statement of whether, in clinical practice, it is replaced continuously.(Source: GN-13 Section 1.4 definitions, pp. 7–8)
Similarly, an IFU that only says “monitors patient parameters” does not show whether the device monitors vital physiological processes in general, or is specifically intended to monitor vital parameters where variations could put the patient in immediate danger. Under GN-13 Rule 10, the first is generally Class B and the second Class C. The classifier needs to go back to the clinical use and alarm functions in the IFU rather than infer from a display, a sensor or a portable form factor.(Source: GN-13 Rule 10, pp. 23–24)
How do you get from product facts to a class, step by step?
GN-13 Section 4 asks the product owner to decide whether the product is a medical device using the appropriate definition, document the intended purpose, and then consider all the rules; where more than one class applies, the highest applicable class is used. The table turns that sequence into a working classification flow.(Source: GN-13 Sections 2 and 4, pp. 11 and 13)
| Step | Question to answer | Record to keep |
|---|---|---|
| 1. Product status | Is it a medical device? Is it an IVD, software or a general device? | Conclusion and basis (relevant parts of GL-06 R2, GN-14, GL-07) |
| 2. Fix the intended purpose | What use, patients, users and setting will be labelled for Singapore? | English intended-use wording confirmed by the product owner, with document version |
| 3. Screen the rule groups | Which of the non-invasive (Rules 1–4), invasive (Rules 5–8), active (Rules 9–12) and additional rules (Rules 13–16) may apply? | For each rule, “applies / does not apply” with the supporting facts |
| 4. Check conditions and exceptions | Are the conditions on duration, site, energy or medicinal products met? Does any exception hold? | Reasons each exception does or does not apply |
| 5. Take the highest class | Of all applicable rules, which gives the highest class? | Final class and the rule that decides it |
“Highest class” assumes the rule genuinely applies. Do not add a high-risk use the facts do not support to play safe, and do not edit out a real use to reach a cheaper route. Where documents are inconsistent, ask the product owner to confirm the version to be submitted.
The flowcharts in GN-13 Appendix A are useful for checking that no branch has been missed, but the guidance states they are illustrative only and classification must follow the rules themselves. We suggest keeping the applicable rules, the supporting evidence and the conclusion in one classification record, so that registration staff can trace each point back to a specific IFU paragraph or model.(Source: GN-13 Appendix A, p. 29)
Illustrative example: why wound use matters even for dressings
The hypothetical cases below follow GN-13 Rule 1 (non-invasive devices in contact with injured skin). They only illustrate how intended use affects classification and are not a classification of any real product. Assume the product meets the rule’s conditions for a non-invasive device in contact with injured skin and that no other rule gives a higher class.(Source: GN-13 Rule 1, pp. 14–15)
| Hypothetical labelled use | Class under Rule 1 | Guidance examples | Facts the manufacturer must support |
|---|---|---|---|
| Only a mechanical barrier, compression or absorption of exudates, for wounds that heal by primary intention | Class A | Compression bandages, cotton wool | Mode of action, and use limited to wounds healing by primary intention |
| Manages the microenvironment of the wound | Class B | Non-medicated impregnated gauze dressings | The microenvironment function and the wounds covered |
| Principally for wounds that cannot heal by primary intention | Class C | Dressings for chronic ulcerated wounds and severe burns | Wound type, healing mode and the labelled scope |
If one IFU lists all three uses, you cannot pick the simplest one, “absorbs exudate”, to classify the device. Conversely, if the product has only been validated for one type of wound, do not add uses without supporting evidence to broaden the marketing. The class should match actual performance, clinical evidence and the labelling to be used in Singapore.
How are main units, accessories and combinations handled?
GN-13 states that where a device is used together with another device, the classification rules apply separately to each. Where a combination produces a new intended purpose, it is classified according to that new purpose. Where devices are combined for convenience and their intended purposes do not change, the class used for the declaration of conformity is that of the highest-class device in the combination. Accessories intended specifically for a particular device are subject to the regulatory requirements that apply to that device.(Source: GN-13 Section 2, pp. 11–12)
Start, then, with an item-by-item list of the main unit, disposables and accessories, stating how each is supplied, what it does and how it relates to the main unit, before discussing classification and grouping. Classification answers the risk class; grouping answers which items can go into one application. Some grouping options have their own risk-class requirements, so each decision needs its own basis.(Source: HSA grouping page)
What should a useful classification record contain?
- The products and models to be sold, the confirmed intended-use wording and document versions;
- The product facts behind the decision (body contact, duration, principle of operation, accessories and combinations);
- Every rule considered, why it does or does not apply, and why any exceptions were ruled out;
- The final class and the rule that decides it;
- Open points: what information is missing and who will provide it. Keep provisional views out of formal declarations.
Only once the class is settled should you confirm the route and technical documents. HSA states that Class A medical devices are exempt from product registration, but the manufacturer or importer must still submit a product notification in SHARE. For Class B, C and D, the evaluation route depends on the risk class, the number of approvals from overseas reference agencies and the length of safe marketing history.(Source: HSA registration overview) For IVD projects, see Singapore COVID-19 IVD classification and grouping rather than applying the general-device examples here.
Frequently asked questions
Can we use our CE or NMPA class directly in Singapore?
An overseas class is useful for comparison, but the Singapore class must come from the GN-13 rules and the actual intended use for sale. Whether an overseas approval supports a shorter route is a separate question: HSA’s reference agencies are the TGA, EU Notified Bodies, Health Canada, Japan’s MHLW and the US FDA, and the approval must cover the same labelled use intended for Singapore. Approvals obtained as Class I or Class II exempt cannot be used for the abridged, expedited or immediate routes.(Source: HSA registration overview)
Are models with the same appearance and principle of operation always in the same class?
Not necessarily. Check for differences in intended use, patients, body contact, duration and clinical function. We suggest building a model comparison table and assessing whether each difference triggers another rule; a shared series name is not evidence of the same class.
Is a home-use product always low risk?
The place of use does not replace classification. For general devices, check the rules against function and intended use, and record the intended users and environment. IVDs are different: GN-14 Rule 4 treats self-testing and near-patient testing as a classification factor. Self-testing IVDs are generally Class C, and Class B where the result does not determine a medically critical status or is preliminary and needs laboratory confirmation.(Source: GN-13 Section 1.2; GN-14 R3 Rule 4, p. 15)
Can we put the result of HSA’s online AI classification tool straight into our application?
We would not. HSA’s AI-enabled risk classification tool is in beta, and the page states that its outputs are estimated classifications for guidance only, not official HSA determinations, and should not be relied on for regulatory submissions or compliance decisions. Use it for an initial cross-check, but base the conclusion on the GN-13 rules and the product facts.(Source: HSA risk classification tool (beta))
If information is incomplete, can we submit at a lower class for now?
We recommend first completing the IFU, design and use information that affects the decision. A preliminary view formed on incomplete data should state its assumptions; if the intended use for sale is not even settled, route and fee estimates can only be scenario budgets.
Official references
- HSA, GN-13 R2.1 Guidance on the Risk Classification of General Medical Devices, Sections 1.2–1.4 (pp. 4–10), Section 2 (pp. 11–12), Section 4 (p. 13), Rule 1 (pp. 14–15), Rule 10 (pp. 23–24), Appendix A (p. 29), September 2018, hsa.gov.sg (PDF)
- HSA, GN-14 R3 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices, Rule 4 (p. 15), July 2023 (effective 24 July 2023), hsa.gov.sg (PDF)
- HSA, GL-07 R2 Guidelines on Risk Classification of SaMD and Qualification of CDSS, July 2025, isomer-user-content.by.gov.sg (PDF); update announcement (Class B criteria under Rule 10(i), CDSS non-medical-device criterion), 21 July 2025, hsa.gov.sg
- HSA, GL-06 R2 Medical Devices Product Classification Guide (whether a product is a medical device), October 2023, isomer-user-content.by.gov.sg (PDF)
- HSA, Guidance documents for medical devices (current versions), page updated 30 September 2026, hsa.gov.sg
- HSA, Register your device: Overview (Class A exemption and product notification, evaluation routes, reference agency approval conditions), page updated 13 March 2026, hsa.gov.sg
- HSA, Grouping of medical devices, page updated 5 October 2026, hsa.gov.sg
- HSA, AI-Enabled Medical Device Risk Classification Tool (beta; outputs are not official determinations), mdrc.hsa.gov.sg
Prepared from official sources verifiable as of 7 October 2026 for manufacturers’ project planning; the risk class of a specific product must be confirmed against its actual intended use for sale, its product facts and the applicable HSA guidance.