China Medical Device Regulatory Landscape: A 2025 Update
Over the last year, there have been significant changes to China’s medical device regulatory environment as the government tries to strengthen regulatory oversight and improve market access for innovative products. The National Medical Products Administration (NMPA) has released new laws, guidelines, and catalog changes that will change how foreign and domestic manufacturers currently operate in China’s medical device market.
Elimination of Country-of-Origin Approval Requirement
In September 2024, the NMPA issued a draft Medical Device Administrative Law (MDAL) for public comment. One of the most important proposals is to eliminate the requirement that imported devices must be approved first in their home country before applying for device registration in China. If enacted, this change would permit foreign manufacturers to pursue regulatory approval in China at the same time as their home markets, significantly reducing time-to-market. Also, this will allow some foreign device products that are not registered and sold in their home country to be exported to China.
Furthermore, the draft MDAL enhances enforcement mechanisms. Penalties for violations of the compulsory product standards will significantly increase, with special attention to high-risk implants. Potential penalties may result in legal liability for local marketing authorization holders and company executives. There will be increased accountability expected of domestic and foreign device entities in China. Additionally, new post-market surveillance obligations and the prohibition of refurbished medical devices in hospitals are further evidence of the government’s push for better patient safety.
Improved Oversight of In Vitro Diagnostics (IVDs)
China has been making a fundamental overhaul with regard to its oversight of in vitro diagnostics (IVD). The new classification catalog came into effect earlier this year, superseding the previous classificationS. All new IVD reagents will be classified using a top-level primary code (6840-XX) based on intended use, as well as a secondary substance code (XX-XXXX). Categories include reagents for blood and tissue products, detection of genetic disease, and companion diagnostics. For applicants that do not find a “fitting” classification in the IVD catalog, applicants will be required to apply to the National Institutes for Food and Drug Control (NIFDC) for classification determination. This application process for the NIFDC should typically take around 4 months until a final decision is made.
In addition, in June 2025, the NMPA provided additional guidance for NGS-based IVD reagents with the new rules now stating sequencing reagents and library construction reagents could be jointly registered together as Class III IVDs, unless their functions are reasonably recognizable as distinct. Companies with existing Class I filings may also have to reclassify their products since, after January 1, 2027, improperly classified NGS IVDs will not be allowed to be manufactured, imported, or distributed. Overall, these measures show that the NMPA is seeking to impose a more structured and consistent approach to regulating IVDs.
Updates to Clinical Trial Exemptions and Innovative Device Evaluation
In May 2025, the NMPA published an updated list of an additional 27 devices that may be exempted from clinical trial requirements, bringing the total of exempted products to 1,047. While the manufacturers might benefit from this exemption of clinical trials and the associated costs, a Clinical Evaluation Report (CER) is normally still necessary as part of the registration process.
In parallel, regulators are prioritizing the approval of innovative medical devices. The CMDE has pledged to make decisions on innovative designation applications within 60 days of submission. Devices with new technologies and improved safety and efficacy will be prioritized for expedited review. However, foreign manufacturers may face more restrictions in obtaining this designation.
Overseas Type Testing for Device Registration
In July 2025, the NMPA suggested that foreign manufacturers could use accredited overseas laboratories for mandatory type testing as part of the application review process in China. Testing data from a foreign lab (certified by independent entities under internationally recognized standards such as ISO/IEC 17025) may now be accepted, which could help reduce costs and time for foreign companies.
Nevertheless, regulators noted that using local testing may still be more convenient, given that local Chinese laboratories are likely have fewer barriers. The new rule is a positive step towards international harmonization. However, practical challenges and complexities are likely to make a lot of companies continue to choose the domestic testing pathway.
Conclusion
All of these regulatory developments signify a significant shift in the medical device regulatory landscape in China. One of the greatest signs of openness to international innovation is the potential removal of the country-of-origin requirement, the broader exemptions for many devices for local clinical trials, and the recognition of accredited lab testing conducted outside the country.
Meanwhile, the more robust enforcement mechanisms in the draft MDAL, changes to the IVD classification, and detailed guidance on NGS-based diagnostics, highlight the NMPA’s ongoing focus on compliance and ensuring patient safety. Global medical device businesses should remain vigilant of China’s changing regulatory standards.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.