Regulatory Reliance

Find out about Medical Device Regulatory Reliance

Medical Device Regulatory Reliance with Medical Device Authority (MDA) of Malaysia

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:

  • In Malaysia: Devices registered with HSA may undergo a verification route (abridged review pathway) through MDA's Conformity Assessment Body (CAB). The review is expected to take 30 working days, compared to 60 working days under the full conformity assessment route. The device will then be registered within 30 working days.
  • In Singapore: Devices registered with MDA will benefit from an abridged review pathway, achieving up to 30% shorter review times across all Class B to D medical devices compared to the turnaround time (TAT) for a standard full route.

Eligibility Criteria
The programme applies to Class B, C and D medical devices that have completed full conformity assessment by MDA's 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.

Application Process
Opt in to the programme:
Select "Regulatory reliance Program: Malaysia Medical Device Authority (MDA)" under Evaluation Route Determinants on the SHARE system when submitting the product registration application. The abridged evaluation TAT will apply.

Documentary Submission:

  1. A copy of the Medical Device Registration Certificate from MDA.
  2. Certificate of Conformity issued by CAB
  3. All required registration documents as specified in GN-15: Guidance on Medical Device Product Registration, based on the Abridged evaluation route.