The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding (MoU) during the 14th ASEAN Medical Device Committee (AMDC) Meeting held in Siem Reap, Cambodia on 22 August 2025. The authorities jointly launched a Medical Device Regulatory Reliance Programme as part of the MOU. The 6-month pilot implementation of this programme which ran from 1 September 2025 to 28 February 2026 has been successfully completed. HSA is committed to the ongoing implementation of the Medical Device Regulatory Reliance Programme.
Medical Device Registration Certificate Holders participating in this programme can expect reduced review times for medical device registration in both countries.
The programme applies to Class B, C and D medical devices that have completed full conformity assessment by MDA’s Conformity Assessment Body (CAB) and MDA evaluation. It excludes devices with different classifications between MDA and HSA; and Class D devices with registrable drugs in an ancillary role.
For more details regarding the Regulatory Reliance Programme, please visit HSA’s announcement in this weblink: https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance
HSA’s GN-15: Guidance on Medical Device Product Registration has also been updated to reflect the documentary requirements for this programme, based on the Abridged evaluation route. The updated GN-15 Guidance can be accessed via the following link: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-15-r13-guidance-on-medical-device-product-registration-(2026-mar)-pub.pdf?sfvrsn=aa3cd904_1