Approval of disinfection products
1、New disinfection products
Implemented by | National Health Commission of the People’s Republic of China |
Official guidelines | https://zwfw.nhc.gov.cn/bsp/xxdcp/202011/t20201124_1518.html |
Item type | Administrative license |
Applicant conditions | enterprises and individuals. |
Approval conditions | approval is granted if the following conditions are met or met.
It conforms to the definition of new disinfection products, is safe and effective, and the technical review conclusion is recommended for approval. |
Delayed review | Under any of the following circumstances, the Notice of Extension of Administrative Licensing Technology Review shall be issued:
1. Technical materials need to be supplemented; 2. It is necessary to conduct on-site review or verification on the product production site; 3. Verification test is required; 4. Other circumstances that the review committee deems necessary to postpone the review. |
Disapproval | Under any of the following circumstances, the Notification of Administrative License Denial shall be issued:
1. Non compliance with relevant laws, regulations, rules, standards, specifications and provisions; 2. The production capacity does not meet the requirements; 3. Failure to provide sufficient safety evaluation materials; 4. The marked effective ingredient content is inconsistent with the measured value, and the inspection result is inconsistent with the product performance; 5. The submitted application materials are inconsistent with the samples, on-site verification and other contents; 6. Providing false materials or concealing the truth; 7. The review committee considers that there are safety risks and other situations that are not allowed. |
Application for review | If the applicant disagrees with the review conclusion in the Notification of Refusal of Administrative License, he/she can apply for review within the specified time. The review department shall organize the review committee to review according to the review application, re review the products if necessary, and issue the technical review conclusion according to the review results. |
Charge or not | No. |
Basis for establishment | Item 201 “Hygienic License for the Production of Disinfectants and Disinfection Instruments” in the annex to the Decision of the State Council on the Establishment of Administrative Licenses for Administrative Examination and Approval Items that Really Need to Be Retained (Order 412 of the State Council in June 2004), implemented by the Ministry of Health.
Appendix 2 to the Decision of the State Council on the Cancellation and Decentralization of 50 Administrative Examination and Approval Items (GF [2013] No. 27), item 1 of the list of administrative examination and approval items that the State Council has decided to partially cancel and delegate to the management level: “Examination and approval except for the production of disinfectants and disinfection devices using new materials, new technologies and new sterilization principles”, implemented by the National Health and Family Planning Commission. |
Catalogue of application materials | application form for health administrative license of new disinfection products, and relevant materials.
Frequently asked questions about the application form: (1) Attached data (please mark “√” in the □ before the provided data): “√” shall be marked for online operation, and “√” shall not be filled in manually. (2) Legal representative (signature): it shall be the signature or seal of the legal representative, and the seal of the legal representative is invalid. (3) Other issues to be explained: the name of the manufacturer shall be filled in, and the Chinese name of the manufacturer shall be filled in for imported products. |
Basic procedures | https://zwfw.nhc.gov.cn/bsp/xxdcp/202011/t20201124_1518.html |
Time limit for handling | 60 working days |
Delivery of results | on-site collection or mail delivery. |
Agency service | If you need agency service or entrusted testing, please write E-mail (caowei@jizhun.com.cn) or call (+86-20-81695425) to contact Mr. Cao Wei. |
2、Approval of production of disinfectants and disinfecting instruments using new materials, new technology and new sterilization principle
Implemented by | National Health Commission of the People’s Republic of China |
Official Guidelines | https://zwfw.nhc.gov.cn/bsp/xxdcp/202011/t20201124_1518.html |
Item type | Administrative license |
Applicant conditions | enterprises and individuals. |
Approval conditions | approval is granted if the following conditions are met or met.
It conforms to the definition of new disinfection products, is safe and effective, and the technical review conclusion is recommended for approval. |
Delayed review | Under any of the following circumstances, the Notice of Extension of Administrative Licensing Technology Review shall be issued:
1. Technical materials need to be supplemented; 2. It is necessary to conduct on-site review or verification on the product production site; 3. Verification test is required; 4. Other circumstances that the review committee deems necessary to postpone the review. |
Disapproval | Under any of the following circumstances, the Notification of Administrative License Denial shall be issued:
1. Non compliance with relevant laws, regulations, rules, standards, specifications and provisions; 2. The production capacity does not meet the requirements; 3. Failure to provide sufficient safety evaluation materials; 4. The marked effective ingredient content is inconsistent with the measured value, and the inspection result is inconsistent with the product performance; 5. The submitted application materials are inconsistent with the samples, on-site verification and other contents; 6. Providing false materials or concealing the truth; 7. The review committee considers that there are safety risks and other situations that are not allowed. |
Review application | If the applicant disagrees with the review conclusion in the Notification of Refusal of Administrative License, he/she may apply for review within the specified time. The review department shall organize the review committee to review according to the review application, re review the products if necessary, and issue the technical review conclusion according to the review results. |
Charge or not | No. |
Setting basis | Item 201 “Hygienic License for the Production of Disinfectants and Disinfectants” in the annex to the Decision of the State Council on Establishing Administrative Licenses for Administrative Examination and Approval Items that Really Need to Be Retained (Order 412 of the State Council in June 2004), implemented by the Ministry of Health.
Appendix 2 to the Decision of the State Council on the Cancellation and Decentralization of 50 Administrative Examination and Approval Items (GF [2013] No. 27), item 1 of the list of administrative examination and approval items that the State Council has decided to partially cancel and delegate to the management level: “Examination and approval except for the production of disinfectants and disinfection devices using new materials, new technologies and new sterilization principles”, implemented by the National Health and Family Planning Commission. |
List of application materials | Application Form for Hygiene Administrative License of New Disinfection Products and relevant materials.
Frequently asked questions about the application form: (1) Attached data (please mark “√” in the □ before the provided data): “√” shall be marked for online operation, and “√” shall not be filled in manually. (2) Legal representative (signature): it shall be the signature or seal of the legal representative, and the seal of the legal representative is invalid. (3) Other issues to be explained: the name of the manufacturer shall be filled in, and the Chinese name of the manufacturer shall be filled in for imported products. |
Basic procedures | https://zwfw.nhc.gov.cn/bsp/xxdcp/202011/t20201124_1518.html |
Time limit for handling | 60 working days |
Delivery of results | on-site collection or mail delivery. |
Agency service | If you need agency service or entrusted testing, please write E-mail (caowei@jizhun.com.cn) or call (+86-20-81695425) to contact Mr. Cao Wei. |