Malaysia–China Medical Device Regulatory Reliance Programme: Pilot Phase I Launched

Malaysia–China Medical Device Regulatory Reliance Programme Pilot Phase I was implemented effective 30 July 2025, introducing a streamlined registration pathway for eligible in vitro diagnostic (IVD) devices. The pilot facilitates faster market access for Chinese manufacturers into Malaysia through regulatory reliance on China’s existing approvals, reducing duplication and shortening review timelines.

Background and Purpose

On 30 July 2025, the Malaysian Medical Device Authority (MDA) officially launched Pilot Phase I of the Malaysia–China Medical Device Regulatory Reliance Programme. The initiative is the world’s first reciprocal regulatory recognition model under the Global Harmonization Working Party (GHWP), following a Memorandum of Understanding signed between MDA and China’s NMPA in November 2023. This pilot reflects Malaysia’s growing role in advancing international cooperation and regulatory innovation for medical devices.

Implementation period: 30 July – 30 September 2025
Scope: In vitro diagnostic (IVD) medical devices only
Objective: To accelerate market access through reliance on trusted regulatory systems

Core Features and Eligibility

For Chinese IVD Manufacturers: Eligible to register products in Malaysia under the Malaysia Verification Pathway
Device types: Class II devices approved by a provincial MPA, or Class III devices approved by China’s NMPA
Priority: Given to devices for rare diseases or innovative technology
Exclusions: Rebranders, relabelers, and third-party brand owners
Application cap: Limited to 6 applications

Significance for Industry

For Chinese manufacturers: Enables faster market access into Malaysia using recognized regulatory approvals
For Malaysian manufacturers: Opens China’s Green Channel for eligible Class B, C, or D IVDs approved by MDA
Efficiency gains: Avoids duplicate review processes, improving speed and predictability

Summary Table

CategoryChinese-made IVDsMalaysian-made IVDsRegulatory RouteMalaysia Verification PathwayChina Green ChannelDevice ClassClass II (provincial MPA) or Class III (NMPA)Class B, C, or D (MDA-approved)Application Limit6 applications6 applicationsReview TimeframeApprox. 30 working daysApprox. 60 calendar daysExclusionsRebranders, relabelers, assemblersRebranders, relabelers, assemblers

Further Information

To read the full announcement from the Medical Device Authority (MDA), please click here.

If you are a medical device company seeking to understand your eligibility or require support preparing a submission under this programme, please contact Cisem

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