A, disinfectants need to declare to what department?
The State Ministry of Health.
Two, which products should be declared according to the disinfectant?
In accordance with the "Classification of Disinfection Products", the following products are included in the management of disinfectants:
1, disinfectants used for disinfection and sterilization of medical and sanitary supplies
2, disinfectants used for disinfection of the skin, mucous membranes (of which the disinfectant used for the disinfection of mucous membranes is limited to medical and health care institutions for diagnosis and treatment)
3, disinfectants used for disinfection of food and beverage utensils
4 Disinfectants for fruits and vegetables
5, disinfectants for water disinfection
6, disinfectants for environmental disinfection
7, disinfectants for disinfection of surfaces
8, disinfectants for air disinfection
9, disinfectants for disinfection of feces, secretions and other dirt
At the same time, according to the Health Supervision issued [2005] No. 208 spirit of the document, dedicated to human feet, eyes, nails, armpits, scalp, hair, nasal mucosa and other specific parts of the disinfection or antibacterial (inhibitory) function of the product, as well as 75% of the mono-particle ethanol disinfectant, etc., is no longer included in the disinfection of the product for acceptance, approval and supervision.
In addition, disposable sanitary products and single-use medical supplies are no longer included in the management of disinfection products.
Three, what is the procedure for the declaration of disinfectants?
Domestic disinfectant declaration procedures:
1. Application for production capacity review (provincial health supervision departments);
2. On-site sampling and sealing;
3. Product testing;
4. Directly to the Ministry of Health to declare the administrative health license.
Declaration of imported disinfectants:
1. product testing;
2. Directly to the Ministry of Health to declare health administrative license.
Four, domestic sub-assembly of imported products how to manage?
Imported health-related products to China's domestic production, processing or subcontracting, should be re-declared as a domestic product health administrative license.
V. What is the production capacity audit?
Production capacity audit refers to the production of technical information submitted by the manufacturer through the verification and on-site audit, according to the product formula (or product structure), production processes and production equipment list to verify whether the manufacturer has the corresponding product production capacity.
Domestic disinfectants in the declaration of permission, should be submitted to the provincial health supervision departments where the manufacturer of product formulations, production processes, production equipment lists and health supervision departments required to provide other production-related technical information, apply for the declaration of the product's production capacity for review. Provincial health supervision departments within five working days after receiving the application to assign more than two staff members to the production site for review, and random sampling at the scene of the sealed samples (the products taken can not be a laboratory preparation of products).
Supervisors responsible for site audit random sampling should be in accordance with the amount of sampling needs to be taken samples should include complete packaging, labeling, and specification samples, in accordance with the requirements of the health administrative law enforcement instruments specification requirements to fill in the "product sample sampling record" single, affixed with a seal. Seal the product for health administrative licensing inspection and review.
Provincial health supervision departments should be in the acceptance of the production capacity of the enterprise audit application within 10 working days, to the reporting unit issued a written audit opinion