Shanxi will crack down on illegal use of medical devices

According to a report from the Provincial Food and Drug Administration on the 13th of May, the reporter from the Provincial Food and Drug Administration on the 13th said that from now on until the end of November, the province will carry out special rectifications of illegally operating illegally used medical equipment and resolutely crack down on 'black-site', 'black-site' and 'black'. Platform''black shop''.

The special rectification is divided into four stages: self-examination, rectification, supervision and inspection, key spot-check and summary supervision. The main tasks are: Executing strict investigations without authorization (for the record) to engage in operations and network sales. medical instruments Behavior; Investigating business operations (network sales) and the use of medical devices that have not obtained a registration certificate or filing certificate; Conducting thorough investigations on the behavior of products with high concern for illegal operations, such as sodium hyaluronate for injection and contact lenses; contact lenses; Three types of medical devices enterprise Implementation of the "Medical Device Business Management Quality Management Regulations" situation; Check the implementation of "medical device use quality supervision and management measures" situation.

It is understood that this rectification will severely punish the illegal activities, and the 'offline' and 'online' remediation will be promoted at the same time. Focus will be on key enterprises, key products, and key clues. The weak links should be taken as the starting point, and violations of laws and regulations should be handled promptly. The punishment must be punished, the exposure must be exposed, the revocation of the license must be revoked, the transfer to the public security agency must be transferred, according to the law to regulate a batch, clean up a batch, investigate and deal with a batch, banned a batch of illegal operations enterprise.