To the Health and Family Planning Commissions (Health Departments and Bureaus) of all provinces, autonomous regions and municipalities directly under the Central Government as well as the Health Bureau of Xinjiang Production and Construction Corps, Chinese Center for Disease Control and Prevention and China National Health Inspection Center:
In order to strengthen the supervision and administration of disinfectant products with administrative license canceled, according to the relevant provisions of the Law of the People's Republic of China on Prevention and Treatment of Infectious Diseases and the Measures for the Administration of Disinfection, National Health and Family Planning Commission (hereinafter referred to as "NHFPC") organized the revision of Regulations on the Hygienic Safety Evaluation of Disinfectant Products (hereinafter referred to as "the Regulations"), which may be downloaded at the "Comprehensive Supervision" column of NHFPC website. Now, it is hereby printed and distributed for your compliance and implementation.
Disinfectants and disinfection instruments that have obtained hygiene license approval documents can continue to be used within the valid period. After the expiration of the valid period, the relevant information shall be converted into hygienic safety evaluation reports and filed in accordance with the requirements of the Regulations; as for disinfectant products that have passed the technical examination and have been listed in the Notice of National Health and Family Planning Committee (GUOWEITONG [2013] No.4), the relevant information shall be converted into hygienic safety evaluation reports and filed before September 30, 2014 in accordance with the requirements of the Regulations.
National Health and Family Planning Commission
June 27, 2014
Regulations on the Hygienic Safety Evaluation of Disinfectant Products
Article 1 The Regulations are formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases, the Measures for the Administration of Disinfection and relevant regulations in order to deepen the reform of the health administrative examination and approval system, standardize the production and operation of disinfectant products, and ensure the effectiveness and safety of disinfectant products used for the prevention and control of infectious diseases.
Article 2 Classification management shall be implemented according to the application of disinfectant products and the risk level of use objects.
Class I disinfectant products are those with high risks, which require strict management to ensure safety and effectiveness, including high level disinfectants and disinfection instruments, sterile agents and instruments for medical items, disinfectants for skin & mucous membrane, biological indicators and chemical indicators of sterilization effect. Class II disinfectant products are those with moderate risks, which require stricter management to ensure safety and effectiveness, including disinfectants, disinfection instruments and chemical indicators except the Class I products, as well as packaging material of sterilized articles with sterilization identification and antibacterial (bacteriostatic) preparations. Class III disinfectant products are sanitary products with low risks except antibacterial (bacteriostatic) preparations and routine management can ensure safety and effectiveness.
When a disinfectant product involves different classes, it shall be managed in a higher risk class.
Article 3 The Regulations shall apply to Classes I and II disinfectant products produced and operated within the territory of the People's Republic of China that do not require administrative examination and approval.
Article 4 The responsible entity shall carry out hygienic safety evaluation of Classes I and II disinfectant products on its own or by entrusting a third party before these products are launched for the first time, and it shall be responsible for the evaluation results. Only disinfectant products that pass the hygienic safety evaluation can be launched into the market.
The responsible entity refers to the unit or individual liable for compensation for personal injury or property losses caused by product defects in accordance with the law. In terms of domestic products, the responsible entity refers to manufacturer, in particular the entrusting party where the production and processing are entrusted; and in terms of imported products, the responsible entity refers to the responsible entity in China.
Article 5 The hygienic safety evaluation shall cover product label (nameplate), instructions, inspection report (including conclusion), enterprise standards or quality standards, hygiene license qualifications of domestic product manufacturers and documents approving that production and sales are allowed of the producing country (region) for imported products. Among them, disinfectants, biological indicators, chemical indicators, packaging materials of sterilized articles with sterilization identification, antibacterial (bacteriostatic) preparations also include product formulas, and disinfection instruments shall also include main components and parts and structural drawings of products.
Standard
GUOWEIJIANDUFA [2014] No.36 Regulations on the Hygienic Safety Evaluation of Disinfectant Products (English Version)
Standard No.
GUOWEIJIANDUFA [2014] No.36
Status
valid
Language
English
File Format
PDF
Word Count
5000 words
Price(USD)
200.0
Implemented on
2014-6-27
Delivery
via email in 1 business day
Detail of GUOWEIJIANDUFA [2014] No.36
Standard No.
GUOWEIJIANDUFA [2014] No.36
English Name
Regulations on the Hygienic Safety Evaluation of Disinfectant Products
To the Health and Family Planning Commissions (Health Departments and Bureaus) of all provinces, autonomous regions and municipalities directly under the Central Government as well as the Health Bureau of Xinjiang Production and Construction Corps, Chinese Center for Disease Control and Prevention and China National Health Inspection Center:
In order to strengthen the supervision and administration of disinfectant products with administrative license canceled, according to the relevant provisions of the Law of the People's Republic of China on Prevention and Treatment of Infectious Diseases and the Measures for the Administration of Disinfection, National Health and Family Planning Commission (hereinafter referred to as "NHFPC") organized the revision of Regulations on the Hygienic Safety Evaluation of Disinfectant Products (hereinafter referred to as "the Regulations"), which may be downloaded at the "Comprehensive Supervision" column of NHFPC website. Now, it is hereby printed and distributed for your compliance and implementation.
Disinfectants and disinfection instruments that have obtained hygiene license approval documents can continue to be used within the valid period. After the expiration of the valid period, the relevant information shall be converted into hygienic safety evaluation reports and filed in accordance with the requirements of the Regulations; as for disinfectant products that have passed the technical examination and have been listed in the Notice of National Health and Family Planning Committee (GUOWEITONG [2013] No.4), the relevant information shall be converted into hygienic safety evaluation reports and filed before September 30, 2014 in accordance with the requirements of the Regulations.
National Health and Family Planning Commission
June 27, 2014
Regulations on the Hygienic Safety Evaluation of Disinfectant Products
Article 1 The Regulations are formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases, the Measures for the Administration of Disinfection and relevant regulations in order to deepen the reform of the health administrative examination and approval system, standardize the production and operation of disinfectant products, and ensure the effectiveness and safety of disinfectant products used for the prevention and control of infectious diseases.
Article 2 Classification management shall be implemented according to the application of disinfectant products and the risk level of use objects.
Class I disinfectant products are those with high risks, which require strict management to ensure safety and effectiveness, including high level disinfectants and disinfection instruments, sterile agents and instruments for medical items, disinfectants for skin & mucous membrane, biological indicators and chemical indicators of sterilization effect. Class II disinfectant products are those with moderate risks, which require stricter management to ensure safety and effectiveness, including disinfectants, disinfection instruments and chemical indicators except the Class I products, as well as packaging material of sterilized articles with sterilization identification and antibacterial (bacteriostatic) preparations. Class III disinfectant products are sanitary products with low risks except antibacterial (bacteriostatic) preparations and routine management can ensure safety and effectiveness.
When a disinfectant product involves different classes, it shall be managed in a higher risk class.
Article 3 The Regulations shall apply to Classes I and II disinfectant products produced and operated within the territory of the People's Republic of China that do not require administrative examination and approval.
Article 4 The responsible entity shall carry out hygienic safety evaluation of Classes I and II disinfectant products on its own or by entrusting a third party before these products are launched for the first time, and it shall be responsible for the evaluation results. Only disinfectant products that pass the hygienic safety evaluation can be launched into the market.
The responsible entity refers to the unit or individual liable for compensation for personal injury or property losses caused by product defects in accordance with the law. In terms of domestic products, the responsible entity refers to manufacturer, in particular the entrusting party where the production and processing are entrusted; and in terms of imported products, the responsible entity refers to the responsible entity in China.
Article 5 The hygienic safety evaluation shall cover product label (nameplate), instructions, inspection report (including conclusion), enterprise standards or quality standards, hygiene license qualifications of domestic product manufacturers and documents approving that production and sales are allowed of the producing country (region) for imported products. Among them, disinfectants, biological indicators, chemical indicators, packaging materials of sterilized articles with sterilization identification, antibacterial (bacteriostatic) preparations also include product formulas, and disinfection instruments shall also include main components and parts and structural drawings of products.
