The Singapore Health Sciences Authority (HSA) has updated regulatory Guidance GN-15 on Medical Device Product Registration to expand the types of approvals from the following reference regulatory agencies:
For Class B Medical Devices, the updated reference agencies’ approval types include:
The US Food and Drug Administration (US FDA)
- De Novo
European Union Notified Bodies (EU NB) via EC certificates issued according to:
- Medical Device Regulation (MDR) Annex IX Chapter I and Chapter III or MDR Annex XI Part A for Class IIa
- In Vitro Diagnostic Medical Device Regulation (IVDR) Annex IX Chapter I and Chapter III for Class B IVD
For Class C and D Medical Devices, the updated reference agencies’ approval types include:
The US Food and Drug Administration (US FDA)
- De Novo
European Union Notified Bodies (EU NB) via EC certificates issued according to:
- Medical Device Regulation (MDR) Annex IX Chapter I and Chapter III, including assessment of technical documentation for implantables or MDR Annex X coupled with Annex XI Part A for Class IIb.
- Medical Device Regulation (MDR) Annex IX Chapter I and Chapter III, including assessment of the technical documentation for Class III
- Directive 90/385/EEC Annex II sections 3 and 4 for Active Implantable Medical Devices (note: Directive 90/385/EEC is incorporated into MDR and active implantable medical device is Class III under MDR)
- IVDR Annex IX Chapter I and Chapter III, including assessment of technical documentation for Class D IVD
- In Vitro Diagnostic Medical Device Regulation (IVDR) Annex IX Chapter I and Chapter III, including assessment of technical documentation for companion diagnostics, self-testing & near-patient testing devices, or IVDR Annex X coupled with Annex XI (except section 5) for Class C IVD.
In essence the above concerns registration applications for higher-risk class medical devices where registration can be submitted via the following routes:
- Abridged Evaluation Route or Immediate Class B Registration Evaluation Route (for Class B devices)
- Abridged Evaluation, Expedited Registration Evaluation Route (for Class C and D devices) and Immediate Class C Registration Evaluation Route.
Please note other recent updates to Guidance on Grouping of Medical Devices for Registration which affect notably dental medical devices and IVF media. Click here for information on the GN-12-2 revision 2 guidance update.
Registering medical devices in Singapore:
To learn more about registering medical devices in Singapore click here.
To learn more about the medical device market in Singapore click here.
To register your medical device in Singapore, please click the button below.