As one of the fastest-growing medical device markets in the world, China offers enormous potential—but navigating its regulatory environment can be challenging, especially for foreign manufacturers. Over the past few years, China’s National Medical Products Administration (NMPA) has rolled out a series of reforms aimed at strengthening oversight, improving product safety, and accelerating innovation. Understanding these changes is crucial for any company seeking market access in 2025 and beyond.
In this article, we break down the most critical updates and what they mean for foreign companies.
1. A Quick Overview: What Is the NMPA?
The National Medical Products Administration (NMPA) is China’s regulatory body responsible for the registration, evaluation, and supervision of medical devices, drugs, and cosmetics. Formerly known as CFDA, the NMPA has become increasingly aligned with international standards – yet it retains unique requirements that distinguish it from FDA, EU MDR, or ISO systems.
2. Key Regulatory Reforms
a) Reclassification of Medical Devices
The NMPA implements a classification catalogue system for medical devices under the guidance of the medical device classification rules. The classification of specific products is primarily based on the Medical Device Classification Catalogue. The Medical Device Classification Rules are used to guide the principles for classification determination as well as the formulation and adjustment of the Medical Device Classification Catalogue.
The NMPA has recently issued a draft to revise the existing medical device classification rules to better align with current technological advancements and international standards.
b) Clinical Evaluation Exemptions (CEE) Expansion
The NMPA continues to expand its CEE list, exempting more devices from local clinical trials if sufficient overseas data or predicate device comparison is available. However, exemption is not guaranteed and requires careful justification.
c) Unique Device Identification (UDI) Rollout
China’s UDI system is based on global principles (similar to EU and FDA), but requires separate submissions in the NMPA’s platform.
d) Electronic Submission & e-RPS
The shift toward a fully electronic registration system (e-RPS) is gaining speed. This system streamlines submission of dossiers, but introduces formatting and platform-specific requirements unfamiliar to some foreign firms.
e) More Emphasis on Post-Market Surveillance
China is tightening expectations around post-market vigilance, traceability, and adverse event reporting. NMPA has published several new guidance documents on supplier control, adverse event response, and field safety corrective actions (FSCAs).
e) Equal participation in government procurement
In 2025, China announced that products produced by enterprises of different ownerships within China participate equally in government procurement activities.
3. What Foreign Manufacturers Must Keep in Mind
Appoint a Legal Agent in China
Foreign manufacturers must designate a China-based legal agent to handle regulatory communication and adverse event reporting.
Local Testing Requirements
Many devices still require in-country type testing at NMPA-accredited laboratories even if internationally certified.
Regulatory Pathways for Innovation
For novel, high-risk devices, China offers an “innovative medical device” pathway with prioritized review, but requires IP ownership and technical advantages. This is a promising but demanding route for cutting-edge manufacturers.
4. Common Pitfalls to Avoid
a) Assuming ISO 13485 or CE marking is sufficient – China has its own QMS requirements.
b) Underestimating timelines – Device registration in China often takes 12–24 months depending on classification and clinical requirements.
c) Skipping local stakeholder engagement – Strong collaboration with a local agent or partner is critical for success.
5. Outlook for 2025 and Beyond
With continued reforms, the NMPA is striving to create a more predictable, transparent, and innovation-friendly regulatory environment. Still, significant differences remain between China’s requirements and those in the EU or U.S. As the market continues to open, foreign manufacturers who invest in regulatory readiness, local partnerships, and strategic adaptation will be best positioned to succeed.
6. Final Takeaway
China is not a plug-and-play market—but it’s a rewarding one for those who do their homework. Stay informed, align your regulatory strategy early, and collaborate with experienced local agents to ensure success.
Need help navigating China’s NMPA regulations? We can help you build a tailored entry strategy, streamline your technical documentation, or connect you with local experts.