Nearly 9,000 Medical Device Business Registrations in Zhengzhou Have Been Revoked

Image source: Official website of Zhengzhou High-tech Industrial Development Zone Management Committee

DentalGoodNews｜Zhengzhou has recently conducted a centralized cleanup of filings for Class II Medical Device operations. According to official announcements from various district market supervision administrations, since 2026, districts such as Zhengzhou High-tech Zone, Jinshui District, and Erqi District have successively issued multiple batches of notices, legally canceling the Class II Medical Device operation filings of a number of enterprises.

According to an incomplete count by DENTALGOODNEWS (Leading Dental Industry Media, DGN) based on official district announcements, as of June 1, 2026, the three districts' notices involve a total of approximately 8,990 enterprises with Class II Medical Device operation filings, including about 3,222 in the High-tech Zone, 4,189 in Jinshui District, and 1,579 in Erqi District. Official announcements indicate that the main reason for the cancellation of these enterprises' filings is that they "no longer meet the original operating conditions, cannot be contacted, and can no longer ensure the safety and effectiveness of their products."

According to the relevant provisions of the "Measures for the Supervision and Administration of Medical Device Operations" cited in the district announcements, enterprises engaged in Class II Medical Device operations must continuously maintain operating premises, storage facilities, quality management personnel, and quality management systems that are commensurate with their business scope and scale. If an enterprise no longer meets the filing conditions, the drug regulatory authority may legally cancel its filing.

Additionally, some announcements point out that after an enterprise's Class II Medical Device operation filing is canceled, its associated medical device online sales filing will be processed simultaneously in accordance with the relevant provisions of the "Measures for the Supervision and Administration of Medical Device Online Sales." This centralized cleanup reflects that Zhengzhou's regulatory authorities are continuously strengthening oversight of the medical device operation sector, conducting standardized governance over filing enterprises that fail to maintain compliant operating conditions.