1. Disinfectants and instruments include:
(1) Disinfectants produced in China not listed in the current edition of China People's Pharmacopoeia or compound disinfectants and disinfection instruments prepared with disinfectants listed in the Pharmacopoeia;
(two) the composition, dosage form or model of disinfectant and disinfection equipment that have obtained the approval number need to be changed;
(3) Disinfectants and instruments newly developed in China;
(4) imported disinfectants and disinfectants produced abroad.
2. Disposable medical and health products that need disinfection and sterilization. Second, the declaration.
Any unit or individual that develops or produces disinfectants and disinfection equipment must apply to the health department (bureau) of the province, autonomous region or municipality directly under the Central Government where it is located, fill in the Application Form for Hygienic License of Disinfectant or the Application Form for Hygienic License of Disinfectant (see Annex for the format), and provide necessary technical data as required. Disinfectants and disinfection equipment produced, sold and used in this province must be examined and approved by the health departments (bureaus) of local provinces, autonomous regions and municipalities directly under the Central Government. Where chemicals and disinfection devices need to be produced, sold and used nationwide, the local health departments (bureaus) of provinces, autonomous regions and municipalities directly under the Central Government shall sign the preliminary examination opinions (including the product quality and production hygiene conditions of the production units) within one month and then report them to the Ministry of Health for approval.
Where disposable medical articles and sanitary articles are produced in China, the production unit shall apply to the local health department (bureau) of the province, autonomous region or municipality directly under the Central Government, fill in the Application Form for Sterilization Hygiene License for Medical Articles and Sanitary Articles (uniformly compiled by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government), and provide application materials as required, which shall be examined and approved by the local health department (bureau) of the province, autonomous region or municipality directly under the Central Government.
Any unit or individual engaged in domestic business or importing or producing disposable medical and health products from abroad shall apply to the health administrative department of the local province, autonomous region or municipality directly under the Central Government and obtain the health license approved by the health administrative department of the government at or above the provincial level. Third, the application data items
1. Application form in triplicate (one of which is the original).
2. Print one original and two copies of the technical data, and bind them into volumes according to the following procedures. The contents include: (1) development report; (2) Test report on killing microorganisms; (3) the content of effective components; (4) Stability report (sterilization stability test can be done for chemicals that cannot be determined by chemical methods); (5) Toxicology test report; (6) Corrosion test; (7) Field use report; (8) User comments.
3, provide samples when necessary (large disinfection equipment can be replaced by structural drawings and photos);
4. Product instruction manual; (official seal of the unit);
5, product quality standards or enterprise standards. Four. agree
After receiving the application materials, the health administrative department of the government at or above the provincial level shall organize an expert review to conduct a comprehensive review of the technical materials. When necessary, it can go to the laboratory recognized by the Ministry of Health for re-examination, or the applicant can make a technical defense, then put forward the review opinions, and make a decision on whether to approve or not within three months. Approved disinfectants, disinfection equipment and disposable medical and health supplies shall be issued with approval number and "Hygiene Permit" by the examination and approval unit.
The format of the approval number of the ministerial Health Permit is (year number), which is valid nationwide. The Health Permit has an original and a copy. The original is held by the applicant and may not be transferred or organized for production. The original and photocopy can be used as technology transfer and organized by the production department. All copies are invalid. If the technology needs to be transferred again, the applicant may submit a new copy of the application, with the original and the production conditions of the production unit (including the technical level and equipment).
Provincial Health Permit can be set according to local conditions and reported to the Ministry of Health for the record.
Disinfectants, disinfectants and medical supplies approved by the health departments (bureaus) of provinces, autonomous regions and municipalities directly under the Central Government shall be reported to the Ministry of Health for the record within three months after approval.
The disinfection identification laboratory approved by the Ministry of Health is responsible for the technical identification of disinfection and sterilization experiments and toxicology experiments. V. Precautions:
1. When applying for a health permit, the applicant shall pay the examination fee according to the relevant domestic regulations.
2. The sterilization test and toxicology test shall be provided by the disinfection appraisal laboratory recognized by the Ministry of Health in accordance with the Technical Specification for Disinfection 199 165438 published by the Ministry of Health in February (the test report shall be valid only if it is signed by the inspection and auditing personnel, indicating my major and title, and stamped with the official seal of the inspection unit). If the product name or instructions indicate that it has disinfection effect on hepatitis or AIDS virus, relevant experimental data must be provided.
3, where the declaration can be used for food utensils and equipment disinfection, skin disinfection drugs should have the corresponding test data, after approval, will indicate in the "health permit" approval can be used for food utensils and equipment disinfection or skin disinfection.
4. Products that have obtained the "Hygiene Permit" with the approval number of the health administrative department of the government at or above the provincial level shall not exceed the approved scope of use or change the instructions and formulas when advertising, and shall be subject to the supervision, monitoring and management of the local health administrative department and health and epidemic prevention institutions.
5. This Hygiene Permit (original and copy) is valid for three years. Two months before the expiration, the product applicant must report to the department that issued the "Hygiene License" on the quality self-inspection of the products produced by the production unit and the monitoring and inspection report provided by the health and epidemic prevention institutions, so as to go through the formalities for replacement.