Notice of the Comprehensive Department of the State Drug Administration on the special rectification operation of the production and operation behavior of standardized decorative color contact lenses

Notice of the Comprehensive Department of the State Drug Administration on the special rectification operation of the production and operation behavior of standardized decorative color contact lenses

Medical Supervision Comprehensive Rigid Management [2022] No. 75

Provincial, autonomous regions, municipalities, and Xinjiang Production and Construction Corps Drug Administration:

In order to further standardize the market order of decorative color contact lenses, effectively strengthen the quality supervision of decorative color contact lenses, ensure the safety of consumers' use of weapon, and jointly issued by the State Drug Administration and the State Administration of Market Supervision "Plan" (National Pharmaceutical Supervision [2022] No. 9) work arrangement, the State Drug Administration decided to organize the three -month standard decorative color contact lenses from September 1, 2022, from September 1, 2022 Special rectification operation. The relevant matters are notified as follows:

1. Work goal

Registers of various medical device, production and operation enterprises, and third -party platforms for online transaction services must strictly implement the "Regulations on the Supervision and Administration of Medical Device" and relevant supporting rules and regulations, strictly implement the main responsibilities of enterprises and platforms, continue to strengthen risk prevention and control and quality management, and effectively strengthen quality management. Guarantee the quality and safety of decorative color contact lenses.

Drug supervision and management departments at all levels must earnestly perform their supervision duties, in accordance with the "four strictest" requirements, adhere to the in -depth rectification and establish and improve the long -term mechanism, severely crack down on illegal criminal behaviors and strengthen daily supervision. The outstanding problems in the color contact lenses market are focusing on the production and operation of unregistered decorative color contact lenses, online violations of laws and regulations, non -medical equipment production and operation qualifications, and over -range operations. Illegalists, exposed typical cases, eliminate hidden dangers of quality and safety risks, establish and improve long -term regulatory mechanisms, form a standardized and orderly market order, and ensure consumer weapon safety.

Second, work task

(1) Standardize the production behavior of decorative color contact lenses. Production enterprises shall establish a quality management system and continue to operate effectively in accordance with the requirements of the "Regulations on the Supervision and Administration of Medical Device", "Measures for the Supervision and Management of Medical Device Production Supervision" and "Regulations on the Management of Quality Management of Medical Device Production". It is necessary to organize production in accordance with the registered product technical requirements to ensure that the decorative color contact lenses from the factory meet the relevant standards and registered product technical requirements.

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.

(2) Standardize the business behavior of decorative color contact lenses. The operating enterprise shall establish a quality management system and effectively operate in accordance with the requirements of the "Regulations on the Supervision and Administration of Medical Device", "Measures for the Supervision and Management of Medical Device Management", and "Regulations for the Management of Medical Device Operational Quality Management." To purchase decorative color contact lenses from qualified manufacturers or operating enterprises, establish and implement the purchase inspection record system and sales record system.

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.

(3) Standardize online sales of decorative color contact lenses. The provider of the third -party platform of the medical device network transaction service shall monitor the sales behavior and information of the decorative color contact lenses on the platform, and find that companies that settle in the third -party platform of online transaction services have over -range operations, false information, exaggerated publicity and other illegal laws. If illegal behavior, inability to get in touch, or other serious security hazards shall immediately stop online transaction services, and save relevant records, and report to the drug regulatory authorities in the local area. Enterprises engaged in decorative color contact lenses should be medical device production and operation enterprises that obtain medical device production licenses and operating permits in accordance with the law. They should display their medical device production and operation licenses on their homepage. The medical device registration certificate of contact lenses, and display the correct methods and precautions of the product, product parameter indicators, wearing decorative color contact lenses that may appear adverse reactions and other contents.

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.

(4) 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.

Third, work requirements

(1) Strengthen organizational leadership and ensure the implementation of work. The quality and safety of decorative color contact lenses is related to the vital interests of the people. Drug supervision departments at all levels should improve their political standing, adhere to people's health as the center, comprehensively deploy, and organize carefully, formulate supervision and inspection work plans in combination Objective tasks should be promoted and implemented in order in order.

(2) Improve the working mechanism and strengthen departmental cooperation. Drug supervision departments at all levels shall form a long -term regulatory mechanism for illegal production and operation of decorative color contact lenses, researching and innovative supervision methods. Relying on the coordination mechanism of the existing drug safety rectification, we must strengthen the coordinated supervision and joint punishment of online information, public security, health, customs, and market supervision departments to jointly crack down on violations of laws and regulations. In the process of investigation and handling of the case, if other areas and departments are involved in other regions and departments, they must report in a timely manner, strengthen communication and cooperation, and form a joint force; if they are suspected of crime, they must be transferred to the public security organs in time.

(3) Strengthen publicity and guidance and create a good atmosphere. Drug supervision departments at all levels should use multiple channels, multiple platforms, and various ways to publicize the society, give full play to the advantages of rapid and wide spread of new media, popularize the knowledge of decorative color contact lenses, guide consumers to purchase from regular channels, professional in professional channels, in professional Under the guidance of personnel, use the product correctly, and pay attention to the use of precautions and possible adverse reactions.

The State Drug Administration will organize inspection teams in a timely manner to supervise and inspect the supervision and inspection work of various places. All provincial pharmaceutical regulatory departments are requested to summarize the special rectification work before December 10, 2022, as well as the main problems, disposal measures, relevant opinions and suggestions found in the supervision and inspection, etc.

Lianhe people: Hu Zunhao, Lei Zhiqi

Electricity: 010-88330682, 88330612

Chuanzhen: 010-88330682

Email: [email protected]

Attachment: Statistical forms of standardized decorative color contact lenses for production and operation behavior

Comprehensive Department of the State Drug Administration

August 30, 2022

appendix

Attachment: Statistical forms of standardized decorative color contact lenses for production and operation behavior

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