National health and family planning commission on further strengthen the regulation of disinfection products matter later notification

The 2015-11-09 national health and population and family planning commission of the People's Republic of China

No. 90 [2015] of the countries who supervision

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps bureau of health, the centers for disease control and prevention, supervision center:

According to the cancellation, and handed over 50 items of administrative examination and approval of the state council the decision of the project of "(guo fa [2013] 27), in July 2013 by commission cancelled in addition to the use of new materials, new technology and new production disinfectants and disinfection sterilization principle of instrument disinfectants and disinfection equipment outside of the administrative examination and approval. To strengthen the supervision of disinfection products, by commission has issued the notice on further strengthening the disinfection products regulatory work (countries who do supervision is sent [2013] no. 18), the disinfection products health regulations of safety evaluation (countries who supervise hair [2014] 36) (hereinafter referred to as the regulations) and the disinfection products health supervision work specification (countries who supervise hair [2014] no. 40). Around two years, actively explore and innovate regulatory way, strengthen the supervision of things after the event and has achieved obvious results. To implement the state council and decentralization, combined the pipes, optimization services, now matter later on further strengthening the disinfection products regulatory matters related to notice the following:

First, strictly implement enterprise's main body responsibility, to ensure product is safe and effective

Enterprise is the guarantee disinfection product is safe and effective the first responsible person, want to earnestly implement the responsibility main body, strictly in accordance with the requirements of laws, regulations and standard is engaged in the production and business operation activities, establish and improve disinfection product manufacturing standard operating procedures and management system. Enterprises shall be conducted for the first, the second category of disinfection products health safety evaluation, evaluation of qualified products before sale, ensure the quality of disinfection product health and safety use. In accordance with the rules of the public in accordance with the relevant information, take the initiative to accept social supervision.

Around to gradually implement credit incentive and disciplinary measures, make the product responsibility unit fully aware of the key role of credit status for their own development, constantly improve the legal consciousness and responsibility consciousness.

Second, the further optimization program, to do a good job of enterprise services

To further simplify the procedures, convenient enterprises, cancel the disinfection products health safety assessment report for the record certificate. Family planning administrative department of public health at the provincial level to the correct understanding for the record to inform, prepare the thesis& nature, do not belong to the administrative examination and approval. To record information complete in accordance with the provisions for the record, and timely public except the enterprise business secret information on record. Should further improve the system, perfect the procedures, strict discipline, strictly enforced, resolutely avoid disguised form for examination and approval, such as fraud and deception behavior. Want to do a good job of enterprise services at the same time, actively explore new form, new way for enterprise services, and create a good environment for the entrepreneurial innovation. To strengthen enterprise in product production and the health and safety evaluation, the direction of exploring to establish disinfection products online registration information service platform, service and improve the pertinence and effectiveness.

All kinds of medical and health institutions at various levels and enterprises in the purchase and use of the first kind, the second category of disinfection products, product liability units should no longer be asked to provide health safety assessment report for the record evidence, can be in accordance with the regulations require reference health safety evaluation report select products, to establish and strictly implement the system of examination and acceptance of goods, carry out disinfection and sterilization effect of detection, in strict accordance with the requirements specification use disinfection products.

Third, strengthen the matter afterwards supervision, in accordance with the serious investigate violation behavior

To further strengthen the regulation of disinfection products matter later, around the implementation of the daily supervision and inspection, random check, reporting, credit management, outstanding issues and risk management, disinfection products outstanding problems that exist in the supervision and weak links, and the annual supervision and inspection and sampling plan, increase of disinfection products manufacturing enterprises and the first kind, the second category of disinfection products supervision and inspection, key check whether the enterprise is in accordance with the specification requirements for production, whether health safety evaluation work in accordance with the requirements, and health disinfection products quality meets the requirements. Random inspection shall be rectified in a timely manner, found problems in the violation behavior to investigate in accordance with the law. Suspected crime, move send a judiciary processing.

Fourth, the public information in time, give play to the role of social supervision

Family planning administrative department of public health at the provincial level and supervision institutions should establish information platform and disinfection disinfection products liability unit credit files, in a timely manner to the public license, registration, supervision and inspection and other relevant information. Permit public content including the company name and address, name and address, the actual production enterprise health license, production categories and project, the release date. Record public content including product liability unit name, name of the actual production enterprise, hygiene license (actual hygiene license for production enterprises), import product responsibility unit in China industrial and commercial business license number, product name and type/specification, product range, disinfection products classification (the first kind, the second category of disinfection products), the inspection report conclusion, health safety assessment conclusion, and put on record date, involving the business secret information will not be made public. To supervise and inspect the information disclosure content mainly includes the unqualified products and product liability unit list, administrative punishment case, etc. To gradually carry out enterprise honesty and blacklist system, through information open, open the complaint report way, fully mobilize and play a role of social supervision, form of government supervision, social supervision and enterprise self-discipline.

The national health and family planning commission

On October 30, 2015