China's National Medical Products Administration (NMPA) has announced the release of updated management regulations for medical device export sales certificates, aimed at supporting medical device export trade and standardizing the issuance process.
The new "Management Regulations on Medical Device Export Sales Certificates" was published on December 24, 2025, through Announcement No. 126 of 2025, and will take effect on May 1, 2026. The regulations will replace the previous rules issued by the former China Food and Drug Administration in 2015 (Announcement No. 18).
The regulations establish a framework for two types of export certificates. Certificate Type I is designated for medical devices already registered or filed in China, confirming that products are approved for manufacture and sale within the country. Certificate Type II applies to medical devices not registered or filed in China but managed as medical devices domestically, certifying that manufacturers meet Good Manufacturing Practice (GMP) requirements.
Medical device registrants, filing entities, or manufacturers with production licenses or filing certificates in China may apply for export sales certificates through their local drug regulatory authorities. Provincial-level drug supervision departments will be responsible for certificate management within their jurisdictions. The maximum processing time for applications is set at 20 working days, excluding on-site inspection and rectification periods. Authorities are encouraged to implement online processing systems.
Certificate validity periods cannot exceed the earliest expiration date among submitted enterprise documents. For Class I medical devices, validity is capped at three years. Electronic certificates will have the same legal effect as paper certificates. Provincial authorities must publicly disclose certificate information within seven working days of issuance and report to the NMPA Information Center within 15 working days.
The regulations emphasize applicant responsibility, requiring companies to ensure exported products comply with importing countries' requirements. Strict penalties are outlined for fraudulent applications, including public invalidation of certificates, notation in credit records, and a five-year ban on obtaining new export certificates for companies providing false materials or forging certificates. Companies on the market supervision serious violation blacklist, those providing false information, or those under production suspension orders will be denied certificates.
The NMPA characterized the regulations as a service measure to facilitate medical device exports while maintaining quality standards. However, the administration clarified that issuing certificates does not constitute evaluation or verification of product compliance with importing countries' requirements—this remains the applicant's responsibility. The new regulations reflect China's ongoing efforts to balance trade facilitation with regulatory oversight in the medical device sector, a key component of the country's healthcare industry development strategy.