Disinfectants record drug product health safety assessment regulations
1 The sterilizing product use, use the object's degree of risk category management.
The first category is a high risk, the need for strict management to ensure safe and effective disinfection products, including high-level disinfectants and disinfection equipment for medical devices, sterilization equipment and sterilization agents, skin and mucous membrane disinfectants, biological indicator material, sterilizing effect of chemical indicators. The second class is a moderate risk, management needs to be strengthened in order to ensure safe and effective disinfection products including disinfectants in addition to the first category of products, disinfection equipment, chemical indicators, as well as sterile goods packaging with sterilization logo , anti (inhibition) probiotics. The third category is the low level of risk, the implementation of general management can guarantee a safe and effective addition to the anti (inhibition) probiotics outside hygiene.
With a disinfecting products when it comes to different categories, the higher risk category should be managed.
2. This provision applies to the territory of People's Republic of China in the production, first class operation does not require administrative approval, the second disinfection products.
3, product liability shall in the first class, second class and disinfection products for the first time before the listing itself or entrust a third party evaluation of health and safety, and responsible for evaluating the results. Health safety evaluation of qualified disinfection product before sale.
Product liability refers to units shall bear a product defect caused bodily injury or property damage liability unit or individual. When domestic enterprises for the production units of product liability, contract manufacturing and processing, especially the Principal; responsibility for the unit of imported products in China responsible units.
4, health safety assessment including product label (nameplate), manual, test report (including conclusions), corporate standards or quality standards, domestic production enterprises health licensing qualification, imported products producing countries (regions) to allow production and marketing approval conditions. Wherein, disinfectants, biological indicators, chemical indicators, sterilization items with packaging sterilization identified antibody (inhibition) probiotics also include product formulation, product disinfection equipment should also include the main components, structure.
Article disinfection product formula should be written with the format and requirements of the actual production of consistent formula in Annex 1.
Article level disinfection of raw material products, the main components of purity and disinfection equipment shall meet the appropriate requirements of raw materials such as disinfection products health standards, technical specifications and corporate standards.
5, a structure diagram sterilized instruments should be consistent with the structure of the actual production of the product, and indicate the name of the main components, technical parameters and quantity.
6, disinfection product label (nameplate), shall comply with the instructions "sterile product label instructions management practices" and relevant health standards.
7, product liability units in disinfection products health safety evaluation, disinfection products should be inspected, and responsible for the authenticity of the sample. All test items should use the same batch completion (inspection items and requirements see Annex 2).
8, disinfection products inspection should be carried out with the corresponding conditions disinfection products inspection bodies. Disinfection products inspection agency shall comply with the relevant provisions of sterilization management, laboratory accreditation, product testing disinfection engaged in activities within the scope of the approved inspection capacity.
Disinfection products inspection agency shall follow the relevant laws and regulations and the provisions based disinfection products health standards, technical specifications and test specifications to carry out inspection, an inspection report (including conclusions), test data and results of the authenticity, accuracy responsible. If health standards, there is no clear specification test methods, can be examined in accordance with corporate standards.
To issue a false inspection reports or poor management is difficult to guarantee the quality of Inspection disinfection products inspection agency, given serious treatment.
9, one of the following circumstances, the product should be re-examined:
(A) the actual production address migration, a separate factory or workshop, turn commissioned production and processing. Among them, disinfectants and anti (inhibition) probiotics should be the determination of the active ingredient, liquid stability test, pH value measurement; disinfection equipment sterilization should be the main factor for determination of strength, do not have bactericidal factor measurement conditions should be simulated field test; biological indicators should be measured the amount of bacteria, chemical indicators should be measured changes in color, with packaging sterilization sterilized items identified should be sterilized penetration factor performance measurement;
(Ii) disinfectants, anti- (inhibition) probiotics extend the expiration date, it shall be effective content, pH value, one of the strongest resistance to microbial kill (or inhibition) test and the stability test; use the original sample inspection just do the stability test;
(C) disinfectants, disinfection equipment and anti- (inhibition) probiotics increase the scope of use or changes in use, it shall make the appropriate physical and chemical, microbiological kill (or inhibition) and toxicological tests.
10, the domestic product standards and quality standards for imported products should meet the following requirements:
(A) disinfectants, anti- (inhibition) probiotics health product standards should include raw material quality requirements (including level of purity), technical requirements (including indicators of sensory, physical and chemical indicators, microbiological indicators, killing microbial indicators) and test methods the type test items, the factory inspection projects; disinfection equipment standard should include the name and type of raw materials, the main components of technical parameters, technical requirements (including sterilization intensity factor, killing microbial indicators) and test methods, types of test items, factory test projects;
(Ii) technical requirements for products should comply with national health laws and regulations, standards and requirements, not lower than the corresponding product health standards;
(C) test methods should comply with national health laws and regulations, standards, specifications and requirements;
Enterprise standard (d) domestic products shall be filed in accordance with law, and within the validity period.
11, health and safety evaluation of product liability should form a complete unit "disinfection products health safety evaluation report," Evaluation report includes basic information and evaluation data of two parts (see format in Annex 3). Health and safety evaluation report valid throughout the country. The first disinfection products health safety evaluation report is valid for four years, the second disinfection products health safety evaluation report long term.
The first class, second class disinfection products first to market, product liability shall be health safety evaluation report to the provincial health planning administration department (registration table in Annex 4). The provincial health administrative department of planning for health safety evaluation report formal examination, complete information shall, within five working days of product liability and issue the registration certificate (registration certificate see Annex 5), and the record of health and safety evaluation report stamped straddle chapter.
After you have completed the evaluation of health and safety products to market, products are subject to change (or structural formula, production process) or the provisions of Article 12 of the present case, the product liability shall update "disinfection products health safety evaluation report" related content to ensure that the evaluation of the product and the production and marketing of products in line at the same time to the original filing authority for the record.
Former first class disinfection products health safety evaluation report expiration, manufacturers should re-evaluate the safety and health record. When disinfection products tested, only for key projects. Where disinfection (sterilization) agent test items as an active ingredient content, pH value and one of the strongest resistance to microbial killing test, disinfection (sterilization) test items as the main instrument sterilization intensity factor and a microbial strongest resistance killing assay, biological indicator test items for the determination of the amount of bacteria, sterilization chemical indicator changes color test items for the measurement. Within two years the national supervision and sampling inspection items may not be qualified to do.
12, product management, and use in the business, using the first class, second class before disinfection products should obtain health safety evaluation report and a copy of the registration certificate. Where hygiene and safety evaluation report of the evaluation data include only the label (nameplate), manual, test report concludes, domestic production enterprises health permits, imported products producing countries (regions) to allow production and sales documents and declarations.
13, above the county level health administrative departments of family planning and comprehensive supervision and law enforcement agencies should strengthen disinfection products enterprises to develop health and safety evaluation of the health supervision and inspection. Planning provincial health administrative departments shall regularly publish company and product health permit evaluation of health and safety-related information.
14, one of the following circumstances, are not in line with national health standards, health specifications or substandard quality of health situation, according to "People's Republic of China Disease Prevention Act," Article 73 or the "disinfection management approach" fourth seventeen processing:
(A) first class, second class and disinfection products not listed before the first evaluation of the health and safety;
(B) a first class disinfection products health safety evaluation report expiration of not re-evaluation of health and safety;
(Iii) issuing false health and safety evaluation report;
(Iv) health and safety evaluation report of the evaluation project or incomplete evaluation report showed that the product does not meet the requirements listed for sale, use;
(V) sterilization expiration date expired;
(Vi) any of the provisions of Article XII of the circumstances, did not re-inspection;
(Vii) after the market are subject to change (or structural formula, manufacturing process) or any of the provisions of Article XII of the circumstances, not for health and safety evaluation report to be updated.
