Regulation Requirements for Disinfection Products in China-Safety Evaluation Report

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The administrative approvals for disinfectants and disinfection instruments (except disinfectants and disinfection instruments manufactured with new materials, new technologies and new sterilization principle) were cancelled from July 2013, according to a notice released by the original authority National Health and Family Planning Commission (NHFPC), and changed to notifications. Products responsible entities must complete the safety evaluation report on their own or entrust a third party to do that before the Class Ⅰ and Class Ⅱ disinfection products are put on market for the first time. Disinfection products that have passed the safety evaluation can then be sold in China legally.

The classification of disinfection products

There are three classes of disinfection products according to the uses and the risk level of using objects:

Class Ⅰ refers to disinfection products with high risks, and this kind of disinfection products need strict management to ensure their safety and effect, including high-level disinfectants and disinfection instruments for medical devices, sterilizing agents and sterilization devices, disinfectants for skin or mucosa, biological indicators, chemical indicators for sterilization effect.

Class Ⅱ refers to disinfection products with moderate risks, and this kind of disinfection products, which include disinfectants, disinfection instruments and chemical indicators not covered by classⅠ, packages of sterilization articles with corresponding logo, antibacterial and bacteriostatic agents, need strong management.

Class Ⅲ is the hygiene products except anti-bacterial and bacteriostatic agents with low risks. Common management can ensure their safety and effect.

The responsible entity of the safety evaluation report

For disinfection products, to finish the safety evaluation report, a responsible entity (units or individuals that shall undertake the compensation liability for personal injuries or property losses which resulted from the products’ defects) is essential. The entities usually need to apply to local health commission for the notifications. For domestic products, the responsible entity is the manufacturing enterprise; for products which are entrusted for processing, it is the entrusting party; and for imported products, it is the Chinese responsible entity.

Contents of the safety evaluation report

The safety evaluation report shall cover product label (nameplate), manual, test report (conclusion included), enterprise standard/ product quality standard, manufacturing license for domestic disinfection products as well as the certificate of sale in the country of origin for imported products.

Besides, safety evaluation report for disinfectants, biological indicators, chemical indicators, packages of sterilization articles with corresponding logo as well as antibacterial and bacteriostatic agents shall also cover product formula; safety evaluation report for disinfection instruments shall cover major components and structure chart of the products.

Use range and validity period of the safety evaluation report

The safety evaluation report is valid nationwide.

Validity period:

Report for Class Ⅰ disinfection products: 4 years;

Report for Class Ⅱ disinfection products: Long term;

Re-examination of the safety evaluation report

Manufacturing enterprises must carry out the safety evaluation and notification again for ClassⅠdisinfection products prior to the due date. It is worth mentioning that not all tests will be required, the enterprises shall only complete the following key testing items for their disinfection products:

Disinfectants: Concentration of the active ingredients, pH value, microbial killing test with the most resistant microbe;

Disinfection instruments: main bactericidal factor strength test, microbial killing test with the most resistant microbe;

Biological indicators: Bacterial content test;

Chemical indicators: Color change status test.

Re-inspection and its requirements

Re-inspections will be required in the following situations:

1. Migration of actual manufacturing address, building of separate factories or plants, entrusting another party to complete the processing

In this situation, the following tests will be required:

  • Disinfectants and antibacterial and bacteriostatic agents need to complete the active ingredient concentration test, stability test and pH value;
  • Disinfection instruments must complete the main bactericidal factor strength test (simulation field trial shall be carried out if conditions for the test of bactericidal factors are not satisfied)
  • Biological indicator must complete bacteria content test;
  • Chemical indicator must complete color change status test;
  • Packages of sterilization articles with corresponding logo must complete sterilization factor penetration property test;

2. Extension of the period of validity for the disinfectants and antibacterial and bacteriostatic agents

In this situation, the following tests will be required: active ingredient content, pH value, microbial killing test with the most resistant microbe and stability test; stability test is required only, if enterprises use the original samples.

3. Extension of application range or change of use method for disinfectants, disinfection instruments and antibacterial and bacteriostatic agents

In this situation, the following tests will be required: physical and chemical test, microbial killing or inhibition test and toxicology test.

Requirements for Inspection Organizations

Tests required for disinfection products must be carried out in the inspection organizations (labs) with corresponding qualifications. The organizations should pass the China Metrology Accreditation (CMA) and should have the ability to conduct tests on disinfection products.