China release 丨 September 1st will launch a special rectification operation of the nation's nationwide for 3 months

China Net, September 1st News Agency issued a notice a few days ago that starting from September 1, 2022, it has organized a three -month -old special rectification operation of standardized decorative color contact lenses.

The notice requires the production behavior of decorating color contact lenses. All provincial pharmaceutical regulatory departments shall focus on whether the production enterprises are organized in accordance with relevant standards and registered product technical requirements, whether raw material procurement and supplier management meet the requirements, whether the key processes and special processes are identified and effectively controlled, and the clean room (clean room (clean room (clean room (clean room ( Area) control whether the requirements meet the requirements and strictly implement the requirements of process inspection, finished product inspection and finished product release.

Standardize the operation of decorative color contact lenses. The pharmaceutical regulatory department shall focus on checking whether the operating enterprise operates a decorative color contact lenses that has not obtained the registration certificate, whether it is unlicensed to operate decorative color contact lenses, whether it is over -the -scale operation, whether the sales of fake and inferior decorative color contact lenses and the expired decorative color contact lenses and the expired decorative color contact lense Its nursing products and other illegal acts. The end glasses mall, glasses shop, residential area, station dock, bustling district, street bridge, underground passage, night market, shopping malls, school surrounding jewelry shops, beauty nail shops, small commodity wholesale markets, township and rural marketing markets, etc. In key areas, the organization implements high -density inspections and repeated inspections of high -density inspections and repeated inspections on third -party platforms and online transaction services for key operations and online transactions.

Standardize online sales of decorative color contact lenses. The drug regulatory department shall focus on checking whether the third -party platform of medical device network transaction services strictly fulfills the legal obligations of qualification information review, commodity information monitoring, and disposal of illegal behaviors; Whether the relevant information is consistent with the registered content, and whether there are illegal to engage in online sales activities, etc.

Strictly investigate various violations of laws and regulations in accordance with the law. Drug supervision departments at all levels should actively improve the "offline+online" supervision platform, give full play to the role of complaints, and achieve timely acceptance, timely disposal, timely investigation, and timely feedback. It is necessary to increase the investigation and punishment of the behavior of decorative color contact lenses for illegal and illegal production and operation. The legal representative, the principals, the person in charge, the person in charge and other responsible persons of the serious illegal illegal enterprise shall be punished severely in accordance with the law and the implementation of the industry's prohibition. Public information on the punishment of cases according to law, increase exposure, and form a strong deterrent. The provincial pharmaceutical regulatory department shall strengthen the spot inspection of decorative color contact lenses produced by registered applicants and trusted production enterprises in the jurisdiction. For products with unqualified supervision and random inspection, they should immediately take corresponding disposal measures to order enterprises to suspend production and analyze the reasons for unqualified analysis. And carrying out rectification, production cannot be restored without review. It is necessary to continue to strengthen the monitoring of adverse events of decorative color contact lenses, and actively take risk control measures to effectively improve product safety after listing.

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