This Country Launches Mutual Recognition of Medical Device Regulation With China

Chinese medical device companies going global in Southeast Asia have achieved a revolutionary breakthrough! On July 16th, the Malaysian Ministry of Health announced the establishment of the world's first national-level medical device regulatory mutual recognition project—the China-Malaysia Medical Device Regulatory Mutual Recognition Plan, which will take effect on July 30, 2025. This marks an unprecedented "30-day fast-track approval" for Chinese companies to enter the Malaysian and broader Southeast Asian markets!

Key Points

① Approval for entering races "Fast Mode":

According to the mutual recognition arrangement, Chinese medical device products that meet the requirements can apply for market approval through the "verification channel" of the Malaysian Medical Device Authority (MDA).

Approval time has been significantly shortened from the standard process to just 30 working days! This is the fastest official channel for Chinese enterprises to enter the Malaysian market!

② "China Certification" gains international recognition, reducing repeated submissions:

Chinese companies can use the approval documents from the National Medical Products Administration of China as a key basis to apply for market authorization in Malaysia.

·Significantly reduce the repeated submission and assessment of technical documents in Malaysia, thereby lowering compliance costs and complexity.

③ Malaysia as a strategic pivot for leveraging the Southeast Asian market:

Malaysia is a major economy in ASEAN, and its regulatory system holds significant influence in the Southeast Asian region. Successfully entering the Malaysian market helps gain regional recognition and lays a stronger foundation for expanding into other ASEAN countries.

This mutual recognition plan greatly enhances Malaysia's appeal as a regional production and distribution hub for Chinese enterprises.