Singapore: Latest Iteration of the Medical Device Product Registration Guidance (GN-15) (w.e.f 24 January 2024)

The Health Sciences Authority (HSA) recently revised the guidance of the medical device product registration (GN-15) under Revision 10 and effectively can be referred to as guidance starting from 24 January 2024.

HSA revised the marketed period for medical devices that will undergo the selected evaluation routes:

• Immediate Class B Registration (IBR) Evaluation Route

• Expedited Class C Registration (ECR) Evaluation Route
  

Medical devices under these 2 routes are required for a minimum of three (3) years marketed in the reference regulatory agencies’ jurisdiction. Otherwise, medical devices listed under Class B and C applications to go through these routes will be rejected.

** Reference Regulatory Agencies: Health Canada, US FDA, Therapeutic Goods Administration (TGA), Japan Ministry of Health, Labour, and Welfare (MHLW), European Union Notified Bodies (EU/NB), and others

All medical devices including in-vitro medical devices (IVD) are compulsory to be registered under HSA unless exempted, for instance, Class A medical devices. For Class B, C, and D, HSA prepared evaluation routes to facilitate the registration of medical devices.

Each evaluation route listed has its eligibility criteria and applicants must ensure the medical devices are complying with the requirements before submitting applications. Also, it is important to note that the immediate, expedited, and abridged evaluation routes are only applicable to those medical devices that have been evaluated and obtained marketing approvals from, at least one of the Global Harmonization Task Force (GHTF) (Australia, Canada, European Union, Japan, and USA).

Source: Health Science Authority (HSA)

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