Hygienic Administrative License for Disinfection Products - Imported Disinfectants (Ministry of Health)
Set in accordance with the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases
Disinfection Management Methods
Charging basis
Charging standard is 3,000 yuan/product
Applying for health administrative license for conditional disinfection products - imported disinfectants
Submission Catalog of Materials When applying for a health administrative license for imported disinfectants for the first time, the following information must be submitted:
Based on: "Regulations on the Application and Acceptance of Health Administrative Licenses for Disinfectants and Disinfecting Equipment of the Ministry of Health"
(1 ) Application form for health administrative license for imported disinfectants
(2) Development report
(3) Product formula
(4) Brief description and diagram of production process
(5) Quality standards
(6) Inspection reports and related information issued by the disinfection product inspection agency recognized by the Ministry of Health, arranged in the following order:
1. Inspection application form
2. Inspection acceptance notice
3. Product manual
4. Physical and chemical inspection report
5 , Microbial killing effect test report
6. Toxicological safety test report
7. Other test reports required by disinfection product inspection regulations
(7) Original product packaging (including product label)
(8) Product instructions
(9) Documents proving that the country (region) of product production allows production and sales
( 10) If applying on behalf of an agency, proof of entrustment should be provided
(11) Other information that may be helpful in the review
If the declared product is produced through entrusted processing, in addition to submitting in accordance with regulations In addition to relevant materials, the following materials must also be provided:
(1) The entrusted processing agreement signed by both the entrusting party and the entrusted production enterprise
(2) The imported products should be provided with the entrusted Certification documents of the manufacturer's quality management system or good production practices
One original copy of the above information, 4 copies, and a small unopened sample package.
To apply to extend the validity period of a license, the following materials should be submitted:
(1) Application form for renewal of sanitary administrative license for disinfectants and disinfection equipment
(2) Hygiene Original license approval document
(3) Product formula
(4) Quality standards or registered corporate standards
(5) Commercially available product labels (devices are Nameplate)
(6) Instructions for use of commercially available products
(7) If applying as an agent, proof of entrustment should be provided
(8) It may be helpful Other materials for review
One original copy of the above materials, plus one unopened small package of a commercially available product.
To apply for changes in licensing matters, the following materials should be submitted:
(1) Application form for change of health administrative license for health-related products
(2) Health license approval document Originals
(3) Other materials
1. Changes in the name and address of the manufacturer:
(1) Imported products must provide relevant government departments or Relevant certification documents issued by accredited institutions. Among them, if the name of the production enterprise is changed due to acquisition or merger between enterprises, a copy of the acquisition or merger contract signed by both parties can also be provided. The supporting documents must be translated into Chinese, and the Chinese translation must be notarized by a Chinese notary authority;
(2) If adjustments are made within the enterprise group, a copy of the change of production enterprise issued by the local industrial and commercial administration agency and the previous change must be provided. Documents proving that the production enterprises belong to the same group; if the subsidiary is an enterprise invested by Taiwan, Hong Kong and Macao or a foreign-invested enterprise, the "Approval Certificate of the People's Republic of China and the Foreign-Invested Enterprise" or the "Approval Certificate of the People's Republic of China and the State, Taiwan, Hong Kong and Macao" can be provided Notarized copy of the Overseas Chinese Investment Enterprise Approval Certificate;
(3) If the change of production site is involved, the hygienic inspection report of the products of the production enterprise after the change should be provided.
Disinfectants need to provide active ingredient content, pH value and stability test reports for three batches of products; disinfection equipment should provide corresponding test reports in accordance with the requirements of the "Disinfection Product Inspection Regulations". For imported products, the Ministry of Health will review the production site and/or sample for re-inspection when necessary.
2. Change of product name:
If you apply to change the Chinese name of the product, you should explain the reasons in the change application form and provide the changed product design and packaging; the foreign name of the imported product No changes are allowed.
3. If you apply for changes to other changeable items, you should explain the reasons in detail and provide relevant supporting documents.
4. If reporting on behalf of an agent, documents proving the entrustment of the agency should be provided.
One original copy of the above information
To apply for a reissue of the license approval document, the following materials should be submitted:
(1) Application for reissue of the health license approval document for health-related products Form
(2) If you apply for a reissue because the approval document is damaged, provide the original health license approval document for health-related products
(3) If you apply for a reissue because the approval document is lost, provide a statement of loss Original copies of newspapers and periodicals at or above the provincial level (the loss statement should be published for more than 20 days)
One original copy of the above information.
To apply for reissue of license approval documents, the following materials should be submitted:
(1) Application form for reissue of health license approval documents for health-related products
(2) Reasons If the approval document is damaged and you apply for a reissue, you must provide the original health license approval document for health-related products
(3) If you apply for a reissue due to a lost approval document, you must provide the original copy of the newspaper or magazine at or above the provincial level that published the loss statement (the loss statement should be published within 20 days) Above)
One original copy of the above information.
Sample of Imported Disinfectant
Sample of Application for Renewal of Disinfectant and Disinfection Equipment
Sample of Application for Public Reissue
Process Process Accepted by the Ministry of Health 5 working days for the Health License Acceptance Office of the Supervision Center
70 working days for the review by the Health License Review Office of the Health Supervision Center of the Ministry of Health
20 working days for approval by the Ministry of Health
Undertaken by Health Supervision Center of the Ministry of Health
Processing time limit: working days
Navigation of lower-level undertaking departments
Form download application form for health license of imported disinfectants
Application form-continuation
Application form-reissue of health-related products