Regulatory Background
To support the export trade of medical devices and standardize the processing of service matters related to the issuance of Export Sales Certificates by drug regulatory authorities, the National Medical Products Administration (NMPA) has revised and issued the Regulation on the Administration of Export Sales Certificates of Medical Devices.
Effective Date and Regulatory Transition
The revised Regulation will take effect onMay 1, 2026. Simultaneously, the "Announcement of the National Medical Products Administration on the Issuance of the Regulation on the Administration of Export Sales Certificates of Medical Devices" (No. 18 of 2015) issued by the former China Food and Drug Administration (CFDA) shall be abolished.
Unlock Your Medical Device Potential with Us
China's export certification requirements are evolving, and timely awareness of regulatory changes is essential for smooth international market access. Qualtech supports medical device companies in interpreting NMPA regulatory updates, assessing export documentation requirements, and preparing compliant Export Sales Certificate applications.
Reach out to our regulatory specialists to ensure your China export activities remain efficient, compliant, and aligned with the latest NMPA requirements. Contact us here!
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