In a move to better regulate the medical device distribution market and strictly uphold safety standards, the city of Hefei has revoked the operating licenses for 665 second-class medical device enterprises this year.

Regulatory authorities discovered during inspections that some companies, after obtaining their second-class medical device operating permits, engaged in violations such as submitting false documentation for their licenses or not operating from their registered business addresses. These actions introduced significant risks into the medical device supply chain. To ensure public safety, the regulatory body has initiated a targeted cleanup campaign with a strict enforcement approach.

For on-site verification, the bureau has distributed the companies' licensing information to local market supervision departments to check the authenticity of the submitted materials and the compliance of their business operations. Furthermore, routine inspections have been intensified, with an annual plan established at the beginning of the year specifying the number of companies to be inspected and the frequency. The focus is on verifying whether companies are still operating from their registered addresses and can consistently ensure product safety and efficacy.

Since the beginning of 2023, Hefei has cumulatively canceled the operating licenses for 8,537 second-class medical device companies, leading to further standardization of market order. Moving forward, the bureau will continue to conduct regular, dynamic reviews of medical device operating qualifications. It aims to improve the market exit mechanism that rewards the competent and eliminates the unfit, reinforce corporate accountability, standardize industry practices, and effectively strengthen the safeguards for public medical device safety.