How to apply for high-tech disinfection equipment in the Health and Health Commission?

Article 1 In order to standardize the application and acceptance of the hygiene administrative license for the production of disinfectants and disinfection equipment (hereinafter referred to as new disinfection products) by adopting new materials, new technologies and new sterilization principles, and ensure the openness, fairness and impartiality of the licensing work, these Provisions are formulated in accordance with the Regulations on the Administration of Hygienic Administrative License for New Disinfection Products and New Waterrelated Products.

Article 2 An entity or individual applying for a new disinfection products (hereinafter referred to as the applicant) shall first log in to the online declaration system of the Health Supervision Center for online declaration, and then submit written declaration materials and samples to the National Health and Family Planning Commission.

Article 3 General requirements of application materials:

(a) Provide 1 original and 4 copies, and the copies shall be clear and consistent with the original;

(2) Apply for supplementary materials, review and terminate the declaration, and provide 1 original;

(three) the original application materials in addition to the inspection report and official documents, should be stamped with the official seal of the applicant page by page (or riding seal);

(four) printed on A4 size paper, bound in the order of submitting the application form, and all materials should be clearly marked to distinguish them;

(5) Use the legal units of measurement in China; if there is no corresponding legal unit of measurement in China, you can use internationally recognized units of measurement;

(six) the contents of the declaration should be complete and clear, and the same item should be filled in consistently;

(seven) all foreign languages (except foreign language addresses, trademarks and other proper nouns) should be translated into standardized Chinese, and the translation should be accompanied by corresponding foreign language materials;

(8) The official seal of the application materials shall be complete and clear;

(nine) the application form shall be signed by the legal representative (person in charge);

(10) If it is an individual application, the application materials shall be stamped with the name stamp or signature of the applicant page by page, and a copy of the applicant's ID card shall be provided.

Chapter II Application Materials

Article 4 To apply for a new disinfection products, the following materials shall be submitted:

(a) the new disinfection products health administrative license application form;

(two) the production capacity audit opinions issued by the provincial health supervision institutions;

(3) Development report;

(4) Quality standards;

(5) inspection methods;

(six) certification documents that the product producing country (region) allows local production and sales (import to New disinfection products);

(seven) the power of attorney of the responsible unit in China (import new disinfection products);

(8) Declaration power of attorney (required when the entrusted agent declares);

(nine) other materials that may be helpful to the review.

Also attach 1 sample. If the length (or width or height) is ≥ 150cm and the weight is ≥ 100kg, color photos (showing the appearance and internal structure) shall be provided.

Article 5 Other application materials:

(1) Supplementary materials shall submit the following materials:

1. Notice of correction of application materials;

2. Relevant supplementary materials.

(2) Supplementary materials shall include:

1. Notice of extension of technical examination of administrative license (copy);

2. Relevant supplementary materials.

(three) to terminate the declaration, the following materials shall be submitted:

If the applicant applies for termination of declaration before the decision is made, the applicant shall submit the Application Form for Termination of Declaration of New disinfection products Health Administrative License.