Classification of Medical Devices in Singapore

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?

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 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.

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.

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