Overview

Pursuant to the “Decision of the State Council on Cancellation and Transfer of 50 Items of Administrative Permits and Other Affairs”, Decree 27 of 2013, approval of disinfectants and disinfection devices not produced by the use of new materials, new technologies, and new principles of sterilization was canceled by the National Health and Family Planning Commission (the former Ministry of Health). Under this newly deregulated market, when these disinfectants and disinfection devices are traded on the Chinese market, they are now required to implement the hygiene and safety assessment on the basis of the national hygiene standards and technical specifications. Local governments are required to conduct supervision and inspection of the enterprises and their products by law.

Regulatory System

 Chinese National or Industry Standards

Disinfectant Product Compliance

According to the “Disinfection Management Measures” and other regulations, the following tasks need to be carried out before the products (including imported disinfectants and domestic disinfectants) puts on the market:

For Fling Products

1. According to GB 38598 and Judgment basis of new materials, new process technology and new sterilization principles, judge that the product does not belong to Three New Products
2. According to the requirements of GB 38598-2020 “General requirement for label and instruction of disinfection products”, the label and instruction should be in compliance.
3. According to the requirements of WS 628-2018 “Technical requirements for the hygiene and safety evaluation of disinfectant products”, relevant tests shall be carried out.
4. According to the requirements of Regulation of Hygienic Safety Evaluation for Disinfectant Products(No.36 Announcement of NHFPC〔2014〕), the disinfection products shall be evaluated for hygiene and safety, and only products qualified in the hygiene and safety evaluation can be put on the market.
5. The responsible unit of the product shall make the complete disinfection product hygiene and safety evaluation report, and submit it to the local health administration department for filling.

For New Disinfection Products

Definition

New Disinfection Products: Disinfectants and disinfection instruments are produced by using new materials, new processes and new sterilization principles.

New materials: The product that is not in the list of effective ingredients of disinfectant raw materials, not in the disinfection and antisepsis category in the Pharmacopoeia of China, and not listed in the current national hygiene standards and norms.

New processes technology: Refers to the change of production technical parameters and/or process flow, resulting in the production and processing technology of disinfectants and disinfection instruments that are equivalent to or better than conventional products in terms of effectiveness, safety and environmental adaptability.

New sterilization principles: refers to the sterilization principle and its indicator produced by physical, chemical, and biological disinfection factors or mutual synergy that are not included in the list of disinfection factors and their corresponding disinfection instruments and indicators.

Judgment basis: GB 38598 and Judgment basis of new materials, new process technology and new sterilization principles.

Compliance requirements: The production and import of new disinfection products shall obtain the Sanitation Permission issued by the National Health Commission (NHC).

Compliance Procedures for Disinfectant Products

For Fling Products

Before the product sells in the market, the responsible unit of the product shall conduct the hygiene and safety evaluation, ensure the product are qualified and be responsible for the evaluation results. Then the responsible unit of the product shall prepare a complete disinfection product hygiene and safety evaluation report, and submit it to the local health administration department for filling. The filling procedures are as follows:

For New Disinfection Products:

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We provide comprehensive Chinese disinfectant product registration service, including

• Policy and regulation consultation
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• New disinfection products declaration
• Test supervision and test report review
• Label management
• Online/On-site regulation training

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REACH24H has very rich experience in Chinese disinfection product registration. REACH24H has helped the TOP 500 domestic companies as well as foreign companies in analyzing product compliance strategies, drawing up compliance plans, and finally successfully completing the China registrations.

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