On 16 July 2025, Malaysia and China achieved a historic milestone by establishing the world’s first Malaysia–China Medical Device Regulatory Reliance Programme, designed to enhance regulatory efficiency and accelerate market access for eligible in‑vitro diagnostic (IVD) devices in both countries. This landmark initiative not only symbolizes regulatory innovation and mutual trust but also reinforces Malaysia’s leadership in advancing international cooperation for medical devices. Under Pilot Phase I, both regulatory authorities agreed to mutually recognize regulatory decisions for IVD devices, with implementation running from 30 July to 30 September 2025.
Building on this success, the Ministry of Health Malaysia announced on 15 June 2026 the launch of a second initiative — the Malaysia–China Joint Evaluation Pilot Programme — which commenced on 1 July 2026 and will continue until 30 September 2026. This programme further strengthens bilateral collaboration by enabling joint regulatory assessments, reducing duplicative evaluations, and accelerating access to safe, effective, and high‑quality medical devices in both markets, while upholding rigorous safety standards.
| Requirement | Phase 1 Malaysia-China Medical Device Regulatory Reliance Programme | Phase 2 Malaysia-China Joint Evaluation Pilot Programme | ||
|---|---|---|---|---|
| Malaysian-Made IVD Devices | Chinese-Made IVD Devices | Malaysian-Made IVD & GMD Devices | China-Made IVD & GMD Devices | |
| Objectives | Enhancing regulatory efficiency and accelerating market access for eligible IVD devices | Enhance regulatory efficiency and accelerating market access through bilateral collaborative assessment, reducing duplicative evaluations | ||
| Programme Period | 30 Jul 2025 – 30 Sep 2025 | 1 Jul 2026 – 30 Sep 2026 | ||
| Regulatory Pathway | China’s Green Channel | Malaysia’s Verification Pathway | Full Conformity Assessment | Special Channel Pilot Programme |
| Facility Ownership | Manufacturer must own and operate its facility in Malaysia | Manufacturer must own and operate its facility in China | Must be based in Malaysia (own & operate the mfg. facility) | Must be based in China (own & operate the mfg. facility) |
| Exclusions | Third-party brand owners (e.g., rebranders, relabelers, assemblers) | – | – | |
| Device Classes | Class B, C, or D approved by MDA | Class II approved by Provincial MPA or Class III approved by NMPA | Class B, C, or D (GMD or IVD) | Class II or Class III (GMD or IVD) |
| Prior Registration Status | – | Not stated | The device MUST NOT have obtained registration certificates in Malaysia or China | |
| Priority | – | Applications involving rare diseases and innovative devices | – | – |
| Application Limit | 6 applications | 6 applications | – | – |
Need Support Navigating the Malaysia–China Regulatory Pathway?
If you are planning to market a medical device in Malaysia that has not yet been registered with China’s NMPA, we encourage you to contact Global Rep. With our extensive experience in managing full conformity assessments in Malaysia, we are well-positioned to ensure a smooth, efficient, and compliant medical device registration process tailored to your needs.
