Singapore’s HSA Medical Device Grouping Tool
Singapore’s Health Sciences Authority (HSA) has recently launched an interactive self-help tool to guide the grouping of medical devices. Certain medical devices may be grouped together in one application to facilitate medical device registration in Singapore.
The chief feature of this tool is its interactive Q&A format. The platform guides you through a series of questions resulting in a potential grouping outcome for your device or devices. Users can enter their medical device name to be included in a final print-out to help guide the registration of their device.
The self-help medical devices grouping tool follows the HSA criteria presented here in Table 1.
Table 1: HSA Singapore Medical Device Grouping
Dental Grouping Terms (DGT)
Dental devices with the same product owner fall under risk classification Class B, with intended purposes that fall within the descriptor of one Dental Grouping Term.
Hearing aids with the same product owner that are of risk classification Class B with the same design, sound amplification, and communication technologies
Immunohistochemistry (IHC) In Vitro Diagnostic (IVD) reagents
IVD reagents and accessories with the same product owner that fall under the same risk classification B or C, based on IHC methodology and within the same IHC Grouping Category
Fluorescence in situ hybridization (FISH) probes
IVD reagents and accessories with the same product owner that fall under the same risk classification B or C, based on FISH methodology and within the same FISH probes IVD Grouping Category
IVD analyzers with the same product owner, proprietary name, risk classification, and methodology, with permissible variants.
In vitro fertilization (IVF) media
IVF media medical devices with the same product owner that are compatible when used together and are intended to be used for an IVF procedure and falls within the same IVF Grouping Category
Medical devices with the same product owner and common intended purpose, and design and manufacturing processes. Variations need to be within the scope of permissible variants.
Medical devices with the same product owner that are meant to be used in combination with a common purpose and are sold under a single system name or label or labeled for use together with the system.
A collection of two or more medical devices that is labeled and supplied in a single packaged unit for a common intended purpose.
A medical device that is sold as a distinct packaged entity and may also be offered in a range of package sizes.
IVD Test Kit
Reagents or articles with the same product owner that are meant to be used in combination for a specific intended purpose. They are sold under a single test kit name or labeled for use with the IVD test kit.
IVD reagents or articles with the same product owner that only fall under risk class B. They are of a common test methodology and fall under the same IVD cluster category.
To be able to use this self-help tool correctly, users will need to know the risk class of their medical device. There are four risk classes of medical devices in Singapore following the Global Harmonization Task Force (GHTF) guidelines from low to high-risk products which can be seen here in Table 2.
Table 2: Singapore Medical Device Classification
Class A (Non-sterile)
Class A (Sterile)
All medical devices, whether manufactured domestically or imported, must be registered with the Health Science Authority before they can be supplied in Singapore, except for Class A low-risk medical devices, which are exempted from product registration. All HSA Singapore product registrations including any future renewals or change notifications must be conducted by a local Registrant through the online Medical Device Information and Communication System (MEDICS).
Please note only local Singaporean companies can apply for a Registrant Account, foreign manufacturers, therefore, have 3 possibilities to register their medical device in Singapore:
- Set up your own legal subsidiary entity in Singapore to register the medical device.
- Appoint a local importer or wholesaler who has a valid dealer’s license, Good Distribution Practice for Medical Devices (GDPMDS) certification and a Registrant Account in Singapore to register the medical devices via MEDICS.
- Appoint an independent third party in Singapore such as Andaman Medical to register the medical devices. Andaman Medical has a valid Registrant Account and acts directly on behalf of foreign manufacturers and distributors. We register and maintain your device license which also means you have the freedom to appoint as many importers or wholesalers for your device as you require while the product license will not be affected by any changes in the distributor network.
You can access HSA’s medical device grouping tool here.
For more information about registering medical devices in Singapore click here.