Singapore's HSA formalises the medical services device regulatory reliance programme with Malaysia


SINGAPORE (Bernama): The Health Sciences Authority (HSA) of Singapore announced on Thursday the full implementation of the Medical Device Regulatory Reliance Programme with Malaysia's Medical Device Authority (MDA), effective March 1, 2026.

It said in a statement that the programme enables medical devices registered with HSA to undergo faster review for access to the Malaysian market.

Similarly, medical devices registered with MDA can now benefit from a shortened review pathway with HSA for entry into the Singapore market.

"This bilateral arrangement allows for more efficient processes and eventually benefits patients as they can gain faster access to safe and high-quality medical devices.

"The six-month pilot project, from Sept 1, 2025, to Feb 28, 2026, was successful with at least 15 HSA-registered products approved by the MDA," HSA said on Thursday.

In addition, HSA announced the signing of a memorandum of understanding (MOU) with Uzbekistan’s Ministry of Health Centre for Pharmaceutical Products Safety to strengthen regulatory cooperation and facilitate safe and efficient access to health products.

HSA chief executive officer Adjunct Professor Dr Raymond Chua, said the collaborations with Malaysia and Uzbekistan allow the republic to reduce duplications, enhance regulatory efficiencies, and expedite access to effective and safe health products.

"We welcome further input and engagement with other regulatory authorities and industry members to explore how HSA could establish itself as a global reference point for regulatory reliance," he said.

-- BERNAMA

 

 

 

 

 

 

 

 

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Singapore , HSA , MDA , collaboration , medical device

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