HSA Singapore Medical Device Classification and Grouping
Medical devices in Singapore are classified based on their level of risk, ranging from Class A (low risk) to Class D (high risk).
HSA Singapore medical device classification rules
Medical devices in Singapore are classified based on their level of risk, ranging from Class A (low risk) to Class D (high risk). The classification rules are adopted from the guidance developed by the Global Harmonization Task Force (GHTF), and they determine the regulatory requirements, and the level of scrutiny devices undergo during the registration process.
The classification rules are based on the expected purpose of the equipment, as well as factors such as usage time, invasiveness in the body, or energy transfer. Before confirming the risk level, all rules should be considered. If there are two or more rules relevant to the device, it will be classified at the highest level. To review the classification rules, refer to GN-13: Guidance on the Risk Classification of General Medical Devices.
SIngapore Medical Device classification tiers
Class A is exempt from registration and does not require a registrant. The importer will list the device on the importer's license through MEDICS during import, and the device will appear in the Class A device database. Low-risk devices include tongue depressors, bandages, and non-invasive diagnostic devices.
Class B requires the registrant to submit an application, and based on the market authorization obtained, the application path is Full, Abridged, or Immediate. Low- to moderate-risk devices include syringes, surgical gloves, and hearing aids.
Class C requires the registrant to submit an application. Based on the market authorization obtained, the application path is Full, Abridged, Expedited, Immediate. Moderate to high-risk devices include pacemakers, infusion pumps, and implantable devices.
Class D requires the registrant to submit an application. Based on the market authorization obtained, the application path is Full, Abridged, or Expedited. High-risk devices include heart valves, drug-eluting stents, and advanced diagnostic imaging equipment.
Medical device grouping in Singapore
Grouping of medical devices allows for multiple products to be submitted under a single registration. According to GN-12-1: Guidance on Grouping of Medical Devices for Product Registration, devices can be grouped as a family, system, IVD test kit, IVD cluster, or group. However, there are different rules for each group type. For example, a family may include products from the same manufacturer that also share the same intended purpose, among other characteristics. A system, however, is a group of products from the same manufacturer that are designed to be used together to achieve the intended purpose.
Frequently
Asked Questions
How are IVDs classified in Singapore?
IVDs are designated into four risk classes based on their risk to the patient and public health: Class A, B, C, and D. They are classified according to a separate set of rules. For more information, refer to GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices.
How is software as a medical device (SaMD) classified in Singapore?
The classification of software follows the same set of rules as other devices. However, the rules will apply differently if the software is embedded in a medical device or standalone software. If the latter, it is considered an active medical device.
From GN-13: “Most software is incorporated into the medical device itself, for example embedded software to operate an electrocardiogram. Some software applications are not incorporated (embedded) into the medical device itself, such as software applications to analyze electrocardiogram signals on a computer independent of the electrocardiogram. These are deemed to be standalone software. Such standalone software applications that fall within the scope of the definition for a ‘medical device’ should be classified as follows:
- where it drives or influences the use of a separate medical device, it should be classified according to the intended purpose of the combination.
- where it is independent of any other medical device, it is classified in its own right using the rules.
- standalone software is deemed to be an active medical device.”
How does classification influence HSA registration requirements?
Classification is just one of the factors that determines your device’s regulatory requirements. Class A exempt devices do not need to register with HSA; all other device classes are required to register. However, your chosen registration route will dictate the submission requirements, time to market, etc. Your device’s regulatory history will determine which registration route you can pursue. For example, if you have registered in other reference markets, have no safety issues and withdrawals/recalls associated with your device, you may be eligible for one of HSA's fastest registration pathways, depending on your device classification and device type.
