China to Adopt Mandatory Hygienic Standard for Pre-marketing Assessment on Disinfection Products

With the concurrent enforcement of the upcoming “Technical Requirements for the Hygiene and Safety Assessment on Disinfection Products” and the former ministerial regulation, the “Rules on the Hygienic Safety Assessment on Disinfection Products”, producers and importers need to comply with the technical requirements set forth in the pending standard when conducting premarketing assessment while follow the administrative procedures stipulated in the Rules, such as product categorization, record-filling and validity renewal etc.

China to Adopt Mandatory Hygienic Standard for Pre-marketing Assessments on Disinfection ProductsOn 22 Jun 2018, China NHC revealed that the final edition of the mandatory hygienic standard “Technical Requirements for the Hygiene and Safety Assessment on Disinfection Products” has been submitted to the SAC (Standardization Administration) for final approval and promulgation. NHC has compiled the draft and issued it for feedback and consultation from June to September of 2017. 96 of 142 of the comments were adopted for final refinement.

The standard will be adopted in parallel with the “Rules on the Hygiene and Safety Assessment on Disinfection Products” by replacing its technical content: producers and importers need to comply with the technical requirements set forth in the standard when conducting premarketing assessment and follow the administrative matters in the rules, such as product categorization, record-filling and validity, etc.

NHC explains that with the power and liability delegation to provincial subordinates and producers, there is an urgent need to improve operability and enforceability of the premarketing assessement on Category I and Category II disinfection products:

  • Category I-high-level disinfectants, sterilizing agents, disinfectors/sterilizers used on medical device, skin and membranes disinfectants and biological and chemical sterilization indicators;
  • Category II-other disinfectants, disinfector/sterilizers and sterilization indicators that do not fall into Category I, packed-sterilized articles with sterilization marking and antimicrobial (bacteriostatic) agents.

The standard offers detailed interpretation on terminology, product category, test scope and reporting of the assessment, as well as minor adjustment on the test object, testing methods and requirements on other administrative documents submitted:

  • If the product was tested under unofficially recognized method, the test should be conducted at 2 different CMA labs;
  • Tests required for ethanol, glutaraldehyde and hypochlorite disinfectants are separately specified;
  • Treated targets/objects are further subdivided into common medical device and endoscope, general common and surgery hand, tableware and food processing equipment, hard surface and fabric surface.

Contents                     

  • Chapter 1 Scope
  • Chapter 2 Reference Documents
  • Chapter 3 Terminology and definitions
  • Chapter 4 General Requirements
  • Chapter 5 Index for the Assessment
  • Annex A Template for the Report of Hygiene and Safety Assessment on Disinfection Products
  • Annex B Tests Required for Disinfectants
  • Annex C Tests Required for Ethanol, Glutaraldehyde and Hypochlorite disinfectants
  • Annex D Tests Required for Disinfectors/Sterilizers
  • Annex E Tests Required for Chemical and Biological Sterilization Indicators
  • Annex F Tests Required for Packed-sterilized Articles with Sterilization Marking
  • Annex G Tests Required Antimicrobial (bacteriostatic) Agents
  • Annex H Template for Test Report of Disinfection Products
  • Annex I Template for Product Formula

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