Before medical device manufacturers can legally sell their products in Singapore, they must comply with medical device regulations set forth by Singapore’s Health Sciences Authority (HSA).
In Singapore, it is important to accurately classify your medical device prior to beginning the HSA registration process in order to select the optimal pathway.
Determining your device 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.
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 non-sterile 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 Registrant services allow us to submit device applications to the HSA on your behalf.
Please contact us for more information on medical device classification and registration in Singapore.