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.
