Anhui will specialize in rectifying medical equipment | focus on tight | 'five classes' | behavior

Medical Network May 16th May 15th, the reporter learned from the Provincial Food and Drug Administration, the province will launch a seven-month crackdown on illegal and illegal use of medical equipment, special rectification actions, severely crack down on the operation of the use of unlicensed medical devices , Without permission (for the record) Engaged in operating medical equipment and other illegal and non-compliance activities to ensure the quality and safety of medical equipment operation and use links.

The special rectification actions will strictly investigate 'black-sites', 'black websites', 'black platforms' and 'black-stores', severely punish the illegal use of medical devices for business operations, promptly investigate and punish major cases, and effectively curb the illegal use of medical devices. The responsibility for the quality and safety of medical device operating companies and users has been further implemented.

During the operation, the food and drug supervision system of various places will carry out five rigorous investigations: that is, strictly inspecting the area without authorization (for the record) to engage in the operation and network sales of medical equipment; strict investigation of operations (network sales) and the use of no registration certificate or record certificate Medical device behavior; Examine the behaviors of products such as sodium hyaluronate for injections, condoms, contact lenses, etc., which are highly concerned with illegal business operations, and strictly investigate the implementation of “quality management of medical device operations” by third-tier medical device operators. "Regulations" situation; strict investigation of medical institutions to implement "medical device use quality supervision and management measures" situation.

The special rectification actions will be promoted by 'off-line' remediation and 'on-line' remediation, focusing on key enterprises, key products, and key cues, taking weak points of supervision as the starting point, carefully organizing investigations, conducting regular inspections, and irregular inspections. Spot checks. Penalties shall be imposed on violations of laws and regulations found during inspections. If the circumstances are serious, they may be revoked for licenses or transferred to public security agencies. Units with problems must supervise their corrective actions, and violations of laws and regulations shall be made in accordance with the law. medical instruments Regulation Require severe investigations. Through rectification, regulate a batch of laws, clean up batches, investigate and deal with batches, and ban a batch of illegal operations. enterprise.