State Food and Drug Administration: Carry out special rectification actions to standardize the production and operation of decorative color contact lenses

On August 30, the website of the State Food and Drug Administration announced that the General Department of the State Food and Drug Administration issued a notice on the special rectification action to standardize the production and operation of decorative color contact lenses, in order to further standardize the market order of decorative color contact lenses, effectively strengthen the quality supervision of decorative color contact lenses, and ensure the safety of consumer devices, in accordance with the "Plan on Deeply Carrying Out Special Rectification Actions for Drug Safety" (Sinopharm Administration [2022] No.
9) jointly issued by the State Food and Drug Administration and the State Administration of Market Regulation, The State Food and Drug Administration decided to organize a three-month nationwide special rectification action
to standardize the production and operation of decorative color contact lenses nationwide from September 1, 2022.
The relevant matters are hereby notified as follows:

 

First, the work objectives

 

All medical device registrants, production and operation enterprises and third-party platforms for online trading services should strictly implement the Regulations on the Supervision and Administration of Medical Devices 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 ensure the quality and safety
of decorative color contact lenses.

 

Drug supervision and management departments at all levels should conscientiously perform their regulatory duties, in accordance with the "four strictest" requirements, adhere to the in-depth implementation of special rectification and the establishment and improvement of long-term mechanisms, severe crackdown on illegal and criminal acts and strengthen daily supervision, in view of the masses to reflect the prominent problems in the decorative color contact lens market, to severely crack down on the production and operation of unregistered decorative color contact lenses, network illegal sales, no medical device production and operation qualifications, beyond the scope of operation and other behaviors, seriously investigate and deal with relevant cases, Punish lawbreakers, expose typical cases, eliminate hidden dangers of quality and safety risks, establish and improve long-term supervision mechanisms, form a standardized and orderly market order, and ensure the safety
of consumer equipment.

 

2.
Work tasks

 

(1) Standardize the production 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 Devices, the Measures for the Supervision and Administration of The Production of Medical Devices and the Good Manufacturing Practices for Medical Devices
.
It is necessary to organize production in accordance with the technical requirements of registered products, to ensure that the decorative color contact lenses leaving the factory meet the relevant standards and the technical requirements of registered products, and the products leaving the factory shall be inspected and accompanied by qualified documents
.

 

Each provincial-level drug regulatory department shall focus on checking whether the production enterprise organizes production in accordance with relevant standards and registered product technical requirements, whether the procurement of raw materials and supplier management meet the requirements, whether the key processes and special processes are identified and effectively controlled, whether the clean room (zone) control meets the requirements, and whether the requirements
of process inspection, finished product inspection and release of finished products are strictly implemented.

 

(2) Standardize the business practices of decorative color contact lenses
.
Operating enterprises shall establish a quality management system and operate effectively in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Operations and the Quality Management Practices for Medical Device Operations to ensure that the operating conditions and business behaviors continue to meet the requirements
.
Decorative color contact lenses should be purchased from qualified production enterprises or operating enterprises, and a purchase inspection record system and sales record system
should be established and implemented.

 

The drug regulatory department shall focus on checking whether the operating enterprises operate decorative color contact lenses without obtaining a registration certificate, whether they operate decorative color contact lenses without a license, whether they operate beyond the scope, and whether there are illegal and irregular acts
such as selling fake and inferior decorative color contact lenses and their nursing products 。 With eyewear malls, optical shops, residential areas, stations and wharves, bustling neighborhoods, overpasses, underpasses, night markets, shopping malls, jewelry stores around schools, beauty nail salons, small commodity wholesale markets, township and rural bazaars, etc.
in the administrative region as the key areas, organize the implementation of drag-net inspections, carry out high-density inspections and repeated inspections of key operating enterprises and third-party platforms for network transaction services, comprehensively check risk points, severely crack down on illegal business behavior, and strive to achieve practical results
.

 

(3) Standardize the online sale of decorative color contact lenses
.
The provider of the third-party platform for medical device online trading services shall monitor the sales behavior and information of decorative color contact lenses on the platform, and if it is found that the enterprises entering the third-party platform of online trading services have illegal and irregular behaviors such as exceeding the scope of operation, publishing false information, exaggerating publicity, etc.
, cannot get in touch, or there are other serious safety hazards, they shall immediately stop the online trading services, keep relevant records, and report
to the local drug regulatory department 。 Enterprises engaged in the sale of decorative color contact lenses shall be medical device production and trading enterprises that have obtained medical device production licenses and business licenses in accordance with the law, and shall display their medical device production and operation licenses in a conspicuous position on their main page, and the product page shall display the medical device registration certificate of decorative color contact lenses, and display the correct use methods and precautions of the product, product parameter indicators, and adverse reactions that may occur when wearing decorative color contact lenses
。

 

The drug regulatory department shall focus on checking whether the third-party platform of the medical device network transaction service strictly performs the statutory obligations of qualification information review, commodity information monitoring, and handling of violations; Whether the network sales enterprise displays the production and operation license and product registration certificate as required, whether the relevant information released is consistent with the registered content, and whether there is any illegal online sales activities
.

 

(4) Strictly investigate and severely punish all kinds of violations of laws and regulations
in accordance with law.
Drug regulatory departments at all levels should actively improve the "offline + online" supervision platform, give full play to the role of complaints and reports, and achieve timely acceptance, timely disposal, timely investigation and handling, and timely feedback
.
It is necessary to increase the intensity of investigation and punishment of the illegal production and operation of decorative color contact lenses in accordance with the law, and strictly punish medical device registrants and production and operation enterprises that deliberately engage in illegal production and operation in accordance with the law, implement the requirements of punishing illegal acts to the person, and severely punish the legal representatives, main responsible persons, directly responsible supervisors and other responsible personnel of enterprises that seriously violate laws and regulations, and implement industry
prohibitions.
Disclose case punishment information in accordance with law, increase the intensity of exposure, and form a strong deterrent
.
Provincial drug regulatory departments should strengthen the sampling of decorative color contact lenses produced by registrants and entrusted production enterprises within their jurisdiction, and immediately take corresponding disposal measures for products that are not qualified for supervision and sampling, ordering enterprises to suspend production, analyze the reasons for unqualifiedness and carry out rectification, and must not resume production
without re-inspection.
It is necessary to continue to strengthen the monitoring of adverse events of decorative color contact lenses, actively take risk control measures, and effectively improve the safety of
post-market products.

 

3.
Work requirements

 

(1) Strengthen organizational leadership to ensure the implementation of work
.
The quality and safety of decorative color contact lenses are related to the vital interests of the people, and the drug regulatory departments at all levels should improve their political positions, adhere to the people's health as the center, comprehensive deployment, meticulous organization, formulate supervision and inspection work plans in combination with reality, decompose and refine target tasks, and promote implementation
according to timely schedule.

 

(2) Improve working mechanisms and strengthen departmental coordination
.
Drug regulatory departments at all levels should study and innovate the ways and methods of supervision in view of the characteristics of illegal production and operation of decorative color contact lenses, and form a long-term supervision mechanism
.
It is necessary to rely on the existing coordination mechanism for special rectification of drug safety, strengthen coordination and joint punishment with departments such as Internet information, public security, health and health, customs and market supervision, and jointly crack down on violations of laws and regulations
.
In the process of investigating and handling cases, where other regions and departments are involved, it is necessary to promptly report them, strengthen communication and cooperation, and form a joint force; Where a crime is suspected, it should be promptly transferred to the public security organs
.

 

(3) Strengthen publicity and guidance, and create a good atmosphere
.
Drug regulatory departments at all levels should use a variety of channels, a variety of platforms, a variety of ways to publicize to the society, give full play to the advantages of rapid and wide dissemination of new media, popularize the knowledge of decorative color contact lenses, guide consumers to buy from formal channels, use products correctly under the guidance of professionals, and pay attention to the precautions for use and possible adverse reactions
.

 

The State Food and Drug Administration will organize inspection teams in due course to supervise and inspect
the supervision and inspection work in various localities.
All provincial drug regulatory departments are requested to report the summary of the special rectification work, as well as the main problems, disposal measures, relevant opinions and suggestions found by the supervision and inspection to the Device Supervision Department of
the State Food and Drug Administration before December 10, 2022.

 

Contacts: Hu Zunhao, Lei Zhiqi

 

Tel:010-88330682、88330612

 

Fax:010-88330682

 

Email: qxjgec@nmpa.
gov.
cn