Notice of the provisions on the hygiene and safety evaluation of disinfection products

Notice of the National Health and Family Planning Commission on Printing and Distributing the Regulations on the Evaluation of the Hygiene and Safety of Disinfection Products.

National Health Supervision Fa 2014 No. 36.

Health and Family Planning Commissions (Health Departments and Bureaus) of all provinces, autonomous regions and municipalities directly under the Central Government, Health Bureaus of the Xinjiang Production and Construction Corps, Chinese Center for Disease Control and Prevention, and Health Supervision Center

In order to strengthen the supervision and management of disinfection products with administrative licenses, in accordance with the relevant provisions of the Law on the Prevention and Treatment of Infectious Diseases and the Measures for the Administration of Disinfection, our committee organized the revision of the "Regulations on the Hygiene and Safety Evaluation of Disinfection Products" (hereinafter referred to as the "Regulations"), which can be obtained from the "comprehensive supervision" column of our committee. It is hereby issued to you, and you are requested to comply with it.

Disinfectants and disinfection equipment that have obtained the approval of the health license can continue to be used during the validity period, and the relevant information shall be converted into a health and safety evaluation report and filed in accordance with the requirements of the provisions upon the expiration of the validity period; The National Health and Family Planning Commission's "Notice" (Guoweitong 2013 No. 4) lists the disinfection products that have passed the technical review, and their relevant information shall be converted into health and safety evaluation reports and filed in accordance with the requirements of the "Regulations" before September 30, 2014.

National Health and Family Planning Commission.

June 27, 2014.

Legal analysis: In order to further deepen the reform of the health administrative examination and approval system, standardize the production and operation of disinfection products, and ensure the effectiveness and safety of disinfection products used for the prevention and treatment of infectious diseases, these provisions are formulated in accordance with the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases, the Measures for the Administration of Disinfection and relevant regulations.

Legal basis: Article 2 of the "Regulations on the Evaluation of Hygiene and Safety of Disinfection Products": Classified management shall be implemented according to the use of disinfection products and the risk degree of the objects used.

The first category is disinfection products with high risk and need to be strictly managed to ensure safety and effectiveness, including high-level disinfectants and disinfection devices used in medical devices, sterilants and sterilization devices, ** mucosal disinfectants, biological indicators, and chemical indicators of sterilization effect. The second category is disinfection products with medium risk that need to be strengthened to ensure safe and effective disinfection, including disinfectants, disinfection equipment, chemical indicators, as well as sterilization packaging and antibacterial preparations with sterilization labels. The third category is the sanitary products with a low degree of risk and routine management that can ensure safety and effectiveness except for antibacterial (antibacterial) preparations.

When the same disinfectant product involves different categories, it should be managed in a higher risk category.

The National Health and Family Planning Commission has issued corresponding policies, requiring that Class I and Class II disinfection products need to conduct health and safety evaluation by themselves or entrust a third party before they are marketed for the first time, and only those that pass the evaluation can be marketed.

That is, before listing, it is necessary to entrust a third-party testing and evaluation agency to conduct a health and safety evaluation, issue a professional test report, and file it on the "National Disinfection Product Online Filing Information Service Platform" before it can be marketed.

Zhongke Testing. It is an independent third-party testing agency under CAS Holdings, Zhongke Testing is familiar with the standard policy of disinfection products, and has the CMA qualification for disinfection product equipment testing, and the disinfection product test report issued can be used for the record of the elimination number, and the disinfection product inspection and slip test report has been recognized by the local health supervision institute.

According to the standard requirements of the product, the number of manuscripts, the number of manuscripts, and the recommended test items of the user, the test data of the product can be communicated with the client in a timely and effective manner during the experiment, and at the same time, the cycle can be guaranteed to help your product go to market as soon as possible.

Summary. Yes, the hygiene and safety evaluation of disinfection products is carried out by the product responsibility unit.

Yes, the hygiene and safety evaluation of disinfection products is carried out by the product responsibility unit.

Excuse me, but please go into more detail?

Yes, the hygiene and safety evaluation of disinfection products is one of the closed responsibilities of the product responsibility unit. As a special biocide, disinfection products have certain safety risks during use. Therefore, in order to ensure the effectiveness and safety of disinfection products, it is necessary to evaluate their hygiene and safety.

The product responsibility unit should be responsible for formulating various evaluation standards and test methods, and conducting all-round evaluation work to ensure that the disinfection products are legal, effective, harmless and reliable. At the same time, if it is found that there is a problem in the dismantling of land poison products, the product responsibility unit should also recall or dispose of the substandard products in a timely manner to protect public health and safety.

(1) Labels (nameplates) and instructions;

2) Inspection report (including conclusion), the report must have CMA qualification, and the qualification certificate is shown below;

3) Enterprise standards or quality standards;

4) Sanitation license for domestic product production enterprises;

5) Supporting documents and customs declarations for production and sales permitted by the country (region) where the imported products are produced;

6) product formula;

7) Disinfection equipment components and structural drawings.

If it is an individual, it is recommended to find someone to do it, and the enterprise has the strength to handle it yourself, and I recommend that you have the technical consultation of Shenzhen comprehensive products.

Prepare samples for testing, generally sent to the Provincial Center for Disease Control and Prevention for testing, but because the Center for Disease Control and Prevention is a national unit with a long testing cycle, it is recommended to contact ** for full authority For details, please pay attention to the contact on the right.

2 4 Routine testing items: sanitizing (bactericidal performance) stability 3 4 Prepare enterprise standards for the record, fill in the application form for disinfectant health and safety evaluation report Materials, etc. 4 4 Send to the Provincial Health and Family Planning Commission for filing.