China NHC Publishes New Mandatory Technical Requirements for Premarketing Assessment on Disinfection Products

The utility and enforceability of regulations and technical requirements of disinfection products has been improved and includes refined content and technical criteria, categorized test scope for different product categories and reduced toxicological tests for disinfecting/sterilizing apparatuses. China still needs to perfect its management system with more specific definitions and criteria for antimicrobial agents and vehicle disinfectants, which are often confused with and marketed as household products, cosmetics, drugs, medical devices or medical supplies

On 12 Oct 2018, China NHC released the hygienic standard “WS 628-2018 Technical Requirements for the hygiene and safety evaluation of disinfection products”, which will be mandatorily implemented starting on the 1st of Mar 2019. The new standard includes some technical amendments to a former ministerial regulation, “Rules on the Hygienic and Safety Assessment on Disinfection Products”. Prior to marketing existing Category I and Category II disinfection products in China, producers and importers need to conduct hygiene and safety assessment and file the assessment report at provincial health departments. WS 628-2018 will be enforced in parallel with the ministerial rules. Producers and importers need to comply with the technical requirements in product testing, sample preparation and report compilation and follow the administrative requirements set forth in the rules.

In 2014, NHFPC (now NHC) delegated parts of its responsibilities to provincial departments and producers/importers and formed categorized management of existing disinfection products.

Table 1-Categorization and Major Corresponding Compliance Obligations of Dinsifectants/Disinfectors in China

Category

III

II

I

Product Scope

Hygiene products(wipes,diapers,sanitary towels, makeup cotton cleaning wipe, paper tableware,contact lens solution and other hygiene-related products ) that do not fall into antimicrobial agents;

  • Other disinfectants, disinfecting apparatuses and chemical   indicators that do not fall into category I;
  • Packed-sterilized articles with sterilization marking;
  • Antimicrobial (bacteriostatic) agents
  • high-level disinfectant/ sterilizing agents, disinfecting/sterilizing apparatuses for medical purpose;
  • Disinfectants for skin and mucous membranes treatment;
  • Biological indicators, and chemical   indicators for sterilization effect;

Risk

Relatively Low

Medium

Relatively High

Obligation

Satisfying labeling requirements

Pre-marketing hygiene and safety assessment and file the record at provincial level;

Satisfying labeling requirements;

Validity of the assessment

/

Permanent

Retest after every 4 years

WS 628-2018 offers greater operability and enforceability with refined content and technical criteria, categorized test scope for different product categories as well as deleting parts of toxicological tests for disinfecting/sterilizing apparatuses. It is worth remembering that criteria and requirements for defining and assessing antimicrobial (bacteriostatic) agents and vehicle disinfectants (disinfectant containing articles such as hygienic wipes, iodine or alcohol cotton) are not yet included into WS 628-2018. Some household products with antimicrobial/biocidal functions are often intentionally confused with or marketed as cosmetics and consumer products such as mouthwash, hand sanitizers and feminine wash, etc. NHC will publish a list of existing active ingredients used in antimicrobial products to better distinguish body-use antimicrobial agents from drug, cosmetic and household chemical products. Currently there is still some confusion as personal disinfectants and contact lens solutions are often confused with medical devices and medical supplies. Upon the official announcement of list of existing active ingredients used in antimicrobial product and the criteria for criteria for the assessment of vehicle disinfectants, China will have realized a comparatively robust system of disinfection products management.

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