The Wuzhou City Market Supervision Administration in Guangxi has initiated a targeted campaign to clean up and regulate medical device distribution enterprises, aiming to address long-standing regulatory challenges such as easy market entry, difficult exit, and inaccurate industry data.

Leveraging smart regulatory tools, the campaign, running from April 2026 through the end of this year, employs an integrated online and offline supervision approach to standardize business practices, optimize the business environment, and ensure the sector's high-quality, healthy development.

Clearing Inactive Entities Through Offline Scrutiny

Focusing on offline inspections, the action aims to eliminate inactive and inefficient market entities. Targeting Class II and Class III medical device distributors, the campaign prioritizes the identification of dormant, shell, and low-efficiency companies.

The administration utilizes the Guangxi Drug Intelligent Supervision Platform and the National Enterprise Credit Information Publicity System to filter out five categories of key enterprises, including those with canceled business licenses and those with long-term zero tax filings, creating lists of "zombie" and "dormant" firms for managed control and rectification.

Regulatory personnel conduct on-site verifications of business premises and storage facilities to confirm operational status. Companies confirmed to be closed or vacant have their qualifications publicly announced and subsequently revoked according to law.

To date, the city has lawfully canceled the distribution filings of 120 Class II medical device enterprises, including 85 with canceled business licenses and 35 long-term uncontactable shell companies.

Implementing Flexible Oversight to Streamline Market Exit

For Class III medical device enterprises with weak compliance, the administration has moved away from a one-size-fits-all approach, adopting instead a flexible service model to facilitate orderly market exit.

For companies facing rectification difficulties or lacking the will to continue operations, regulators conduct on-site visits to educate them on legal obligations, informing them of the safety and credit risks associated with holding inactive qualifications, and guiding them towards voluntary deregistration.

Simultaneously, efforts have been strengthened to optimize the deregistration service through inter-departmental coordination. By leveraging government service platforms to enable fully online processing, streamlining required documentation, and compressing the processing timeline to 0.5 working days, the efficiency of market exit has been significantly enhanced.

Since the beginning of this year, 21 Class III medical device enterprises have been guided to voluntarily cancel their operating permits.

Strengthening Online Monitoring to Curb Illegal Sales

In the realm of online supervision, the administration has formed evidence collection teams. Utilizing intelligent monitoring via regulatory platforms, it has shifted to a proactive supervision model to seek out and investigate illegal online sales of medical devices.

One case of illegal online medical device sales has been identified, involving a company accused of misusing registration certificates to sell devices and illegally selling medical consumables to individuals. The case has been filed for investigation and punishment, effectively curbing irregular online business practices.

Establishing a Long-term Regulatory Framework

This special campaign has clarified the regulatory landscape of the industry, optimized the allocation of regulatory resources, and reinforced the compliance responsibilities of enterprises. Moving forward, the Wuzhou City Market Supervision Administration plans to establish a routine inspection mechanism, strengthen closed-loop, full-chain supervision, and maintain focus on issues like shell companies and illegal online sales to deepen the ongoing rectification efforts and solidify the defense line for public medical device quality and safety.