Singapore and Malaysia launch medical device regulatory reliance programme

This aims to streamline registration of several medical devices.

Singaporean and Malaysian authorities have launched the Medical Device Regulatory Reliance Programme, a six-month pilot project to fast-track registration of certain medical devices.

According to a joint statement, the Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a memorandum of understanding for the programme running from 1 September 2025 to 28 February 2026,

The pilot programme will streamline the registration of Class B, C and D medical devices.

Through this initiative, the parties aim to deliver for faster approvals through reliance on each other’s regulatory assessment and approvals, reduce duplications of reviews, cutting costs and time-to-market, and provice earlier patient access to safe, innovative and high quality medical technologies.

“Both regulators will work closely to test streamlined pathways, refine and establish clear standard operating procedures for the reliance pathway, validate shortened processing timelines and gather stakeholders’ feedback, so that an effective and scalable regulatory reliance programme can be built after the pilot,” the statemen read.

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