Malaysia leads global medical device regulatory reliance with China
The initiative, led by the Medical Device Authority Malaysia (MDA), marks a strategic leap in streamlining approvals for medical devices between the two nations.
MDA chief executive Dr P. Muralitharan stated that the programme allows mutual recognition of pre-market approvals, significantly reducing processing times.
Malaysian in-vitro diagnostic (IVD) devices will now qualify for China's Green Channel, while Chinese devices can utilise Malaysia's Verification Pathway, cutting approval periods to 60 and 30 working days, respectively.
'This collaboration eliminates regulatory duplication, speeds up market entry, and ensures faster patient access to advanced medical technologies,' Muralitharan said.
'It also solidifies Malaysia's reputation as a regional regulatory leader and boosts investor trust in our healthcare ecosystem.'
The programme was unveiled at the Healthcare Information and Management Systems Society Asia-Pacific (HIMSS APAC) Health Conference & Exhibition 2025, following a memorandum of understanding signed between MDA and China's National Medical Products Administration (NMPA) in November 2023.
Muralitharan encouraged industry players to engage with MDA for further details, emphasising the programme's role in fostering efficient and transparent healthcare regulation.
The initiative officially begins on July 30, reinforcing Malaysia's commitment to global health innovation. - Bernama
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