The Health Sciences Authority (HSA) Singapore has published the latest guidance document on medical device product registration in January 2022.
Under the evaluation routes for the registration of medical devices in Class B, C and D, the “De Novo” classification pathway (under the US Food and Drug Administration) has been included as a type of approval that can be considered for the abridged and immediate evaluation routes.
Some of the other types of approvals that qualify are “Medical Device Regulation (MDR) Annex IX Chapter I and Chapter III or MDR Annex XI PART A for Class IIa” and “In Vitro Diagnostic Medical Device Regulation (IVDR) Annex IX Chapter I and Chapter III for Class B IVD” under the European Union Notified Bodies.
More details can be found in “Medical Device Guidance – GN-15: Guidance on Medical Device Product Registration, January 2022”: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gn-15-r8-_guidance-on-medical-device-product-registration-(2022-jan)-pub.pdf