• 2026-07-27 03:03:43

The Medical Device Authority (MDA) of Malaysia has announced a commencement of the second phase of The Malaysia–China Joint Evaluation Pilot Programme upon successfulness of Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I) in 2025. Pilot phase 2 will run from 1 July 2026 to 30 September. The programme enables the MDA and China's National Medical Products Administration (NMPA) to conduct a collaborative joint evaluation of eligible medical device registration applications under the GHWP Common Evaluation Reliance Practice (CERP).

• 2026-07-27 01:56:36

On June 1, 2026, the NMPA issued an announcement to further clarify the work related to registration and filing following the adjustment of the management classification category of medical device products. The announcement covers various scenarios, including initial registration, renewal registration, and change registration, and sets forth corresponding requirements for the production, distribution, and import of the products.

• 2026-01-30 04:16:17

NMPA released the 2025 Catalog of High-End Medical Devices for Priority Approval to expedite the registration process for innovative high-end medical devices.

• 2026-01-30 03:45:43

The NMPA issued revised regulation on the administration of export sales certificates of medical devices, effective May 1, 2026.

• 2025-12-26 03:21:16

On November 4, 2025, the NMPA released the revised Good Manufacturing Practice for Medical Devices (GMP), the regulation will officially enter into force on November 1, 2026, at which time the 2014 version shall be repealed.

• 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 2025-07-14 01:44:36

The NMPA issued the Catalog of Medical Devices Exempt from Clinical Evaluation (2025), which took effect on May 12, 2025.

• 2025-05-29 10:06:54

On April 28, the National Medical Products Administration (NMPA) issued the Guidelines for Quality Management of Online Sales of Medical Devices, which will come into effect on October 1, 2025.

• 2025-05-06 08:38:10

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