China’s National Medical Products Administration (NMPA) has issued the “Administrative Provisions for Medical Device Export Sales Certificates” 《医疗器械出口销售证明管理规定》, a major new regulatory framework for medical device exports. The provisions were formally released in December 2025 and are set to take effect on 1 May 2026, replacing the previous certificate rules from 2015.
The new regulation is part of China’s broader effort to deepen medical product regulatory reform and support the international growth of the domestic medical device industry. It standardises and clarifies procedures for issuing export sales certificates that verify a medical device is permitted to be manufactured and sold domestically (or meets specific production and quality requirements if not yet registered in China).
Key Elements of the New Rules
Two Types of Certificates:
- Export Sales Certificate (I): For medical devices that are registered or filed in China, confirming they are approved for domestic production and sale.
- Export Sales Certificate (II): For devices not registered or filed in China but produced by a manufacturer that has the required production licence and meets quality management norms.
- Expanded Eligibility: The regulation broadens who may apply for certificates. Previously limited to registered or filed products, it now includes qualified production enterprises with appropriate licences and compliance systems.
- Clear Application and Documentation Requirements: The rules specify what documentation must be submitted, quality management system evidence, and how authorities will assess applications.
- Facilitating Export: By simplifying procedures and expanding eligibility, the regulation aims to enhance service quality, reduce administrative friction, and better support Chinese medical device manufacturers in exporting products globally.
Strategic Context and Impact
This regulatory change reflects China’s push to grow its medical device export sector and align export documentation processes with international trade practices. With global demand for high-quality medical devices rising, clearer and more efficient export certification will help Chinese manufacturers compete more effectively in international markets. At the same time, harmonised export documentation can assist customs clearance and regulatory acceptance abroad, reducing trade barriers for Chinese medical device exporters.
Official legal source of Announcement No. 126, 2025 published under NMPA: