ANSWERED ON THIS PAGE:
- What is the medical device classification scheme in Singapore?
- How do I determine my device classification?
- How can I register multiple devices in Singapore?
Singapore's HSA medical device classification
In Singapore, it is important to accurately classify your medical device prior to beginning the registration process. The Health Science Agency (HSA) imposes different registration routes for each classification. Selecting the appropriate route is essential, as it can significantly affects costs, submission requirements, and approval times. Emergo's experienced regulatory consultants can help you identify the correct classification and registration route for your device.
Determining medical device risk classification in Singapore
The first step in the Singapore registration process is to determine the classification of your device by referencing the Health Sciences Authority's GN-13: Guidance on the Risk Classification of General Medical Devices or GN-14: Guidance on the Risk Classification of In-Vitro Diagnostic Medical Devices. The HSA uses a set of 16 rules to classify general medical devices as Class A (non-sterile or sterile), B, C, or D based on increasing risk.
Medical device classifications in Singapore are generally aligned with classification in the European Union; however, IVD classification is not reflective of the EU, but more closely aligned with Canada or Australia.
The rules for medical device classification are separated into the following categories:
- Non-invasive medical devices
- Invasive medical devices
- Active medical devices
- Additional rules pertaining to devices incorporating medicinal products, contraceptive products, disinfectant products, and medical products manufactured from the tissues or cells of humans or animals.
Class A medical devices do not need to be registered with the HSA; however, all others must be registered prior to commercialization in the Singaporean market.
Why choose Emergo to assist with medical device classification?
Emergo’s Singapore team has extensive experience in HSA classifications and registrations.
- Our team specializes in medical device regulatory consulting and can help you determine the proper classification for your medical device or IVD. This is especially important if your device technology is novel and new to the Singaporean market.
- We can assist in preparing medical device submission documents.
- Our in-depth knowledge of the Singapore medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.
- Our Singapore Local Representation services allow us to submit device applications to the HSA on your behalf.
Common Singapore device classification questions
Do the classification rules for medical devices apply to IVDs?
The IVD classification system in Singapore has four classes and is also governed by risk. There are seven classification rules for IVDs. The system is as follows:
- Class A: Low individual risk and low public health risk
- Class B: Moderate individual risk and/or low public health risk (e.g. pregnancy self-test)
- Class C: High individual risk and/or moderate public health risk (e.g. blood glucose self-test)
- Class D: High individual risk and high public health risk (e.g. HIV blood diagnostic)
What is product grouping?
Grouping allows similar devices to be registered with a single submission. GN-12: Guidance on Grouping of Medical Devices for Product Registration outlines requirements for product families, systems, groups, IVD test kits, and IVD clusters. The appropriate grouping strategy can impact the number of registrations required as well as the cost. Emergo can help you identify the best grouping strategy if you wish to register multiple devices, systems, kits, or other complex product configurations in Singapore.
What is the medical devices risk classification tool?
This is an online tool developed and provided by the HSA to help medical device manufacturers identify the correct classification for their devices. The tool leads you through a rule-based questionnaire about your device to determine its class based on the HSA classification guidance documents. The HSA encourages users to confirm the results of the tool.