Linyi, Shandong launches special inspection of Medical Devices in Oral healthcare institutions to strictly regulate the safety of device use.

Source: Linyi Municipal Market Supervision Administration

DentalGoodNews｜Recently, the Linyi Municipal Market Supervision Administration announced that it has recently organized a special supervision and inspection of Medical Devices in Oral healthcare institutions, using Tancheng County as a demonstration area, focusing on three key areas: incoming goods inspection, storage management, and equipment operation and maintenance, to identify risks and hidden hazards.

Before the inspection, the regulatory authorities conducted file creation and baseline surveys of Oral healthcare institutions in the jurisdiction, refined inspection checklists based on key risks, and carried out targeted inspections. In terms of incoming goods inspection, the focus was on verifying the procurement channels, product qualifications, supplier qualifications, purchase invoices, and acceptance ledgers for Medical Devices such as Dental Implants, Orthodontic materials, and disinfection and sterilization equipment, to prevent Medical Devices of unknown origin from entering the diagnosis and treatment process.

In terms of storage management, the focus was on inspecting the expiry management of disposable Medical Consumables such as impression materials, articulating paper, and Orthodontic wires, as well as temperature and humidity monitoring equipment and related records. In terms of equipment operation and maintenance, the maintenance and servicing records of in-use Medical Devices such as dental comprehensive treatment units and ultrasonic scaling equipment were verified.

According to the Linyi Municipal Market Supervision Administration, as of November 6, 2026, the Tancheng County Market Supervision Administration had cumulatively inspected 73 Oral healthcare institutions, identified 6 safety risks and hidden hazards, and urged 27 to complete rectification.

In addition to on-site inspections, the local authorities have also implemented a flexible regulatory model. In response to issues such as insufficient regulatory knowledge among some practitioners in Oral healthcare institutions and non-standard filling of ledger records, regulatory personnel provided on-site guidance on the standardized completion of records for Medical Device procurement, incoming goods inspection, and maintenance. For minor issues identified during inspections, on-site guidance for rectification was provided.

In terms of departmental collaboration, the market supervision authorities have strengthened coordination with health authorities, carried out joint inspections, and established mechanisms for information exchange and clue sharing. For illegal and non-compliant activities such as the use of unregistered or unrecorded Medical Devices and expired or invalid Medical Devices, strict handling in accordance with the law was carried out, and institutional compliance awareness was strengthened through case-based legal education and warning interviews with responsible persons.

Incoming goods inspection and expiry management of Medical Devices are also key priorities in regulatory enforcement in other regions. According to previous reports by DGN, on August 17, 2026, a Dental clinic in Chengdu was fined 10,000 yuan by the Chengdu Municipal Market Supervision Administration for failing to establish and implement a Medical Device incoming goods inspection record system after receiving a warning; on October 8, 2026, the Jiangmen Municipal Market Supervision Administration imposed an administrative penalty on a hospital, which was ordered to confiscate 3 pieces of equipment and fined 38,000 yuan for using expired dental comprehensive treatment machines to provide medical services.

The Linyi Municipal Market Supervision Administration stated that next steps will include continuously strengthening routine supervision of the Medical Device use phase, improving mechanisms for daily inspections, random spot checks, and closed-loop problem management, further promoting the integration of regulatory enforcement with services, and standardizing the order of Medical Device use.