Application for Production License of disinfecor

一、Regulation Overview

Disinfection products refer to disinfectants, disinfection apparatus (including biological indicators, chemical indicators and sterilized packaging ), sanitary products and disposable medical products. In China, according to the Measures for the Administration of Disinfection, a factory producing disinfection products must obtain a Hygiene License of Disinfection Product Manufacturer before production. According to the risk category of the products produced, the first and second category of disinfection products must be filed before they go on the market, and the new disinfection products can only be produced and imported after obtaining the administrative license.

 

二、Application Process

Step 1: Plant site and workshop planning.

Step 2: Renovate or adjust the existing workshop according to the plan (conversion or expansion).

Step 3: Personnel and equipment preparation.

Step 4: Documents for establishing management system.

Step 5: Compile the whole set of application materials and submit to the local Health Commission.

Step 6: ZOOP conducts personnel training.

Step 7: On-site review by the Health Commission.

Step 8: Approval and issuance of Hygiene License.

Regardless of the renovation time, the entire period is about 1-3 months. The final period mainly depends on the customer's situation and whether the local health commission can arrange the on-site review in time.

Factories that have obtained temporary licenses during the epidemic period need to obtain a Hygiene License for the Production of Disinfection Products after the outbreak is over before they can normally produce disinfection products.

During the processing of hygiene license, there is no need for product testing. After obtaining the production license, each product shall be conducted for safety and hygiene evaluation before being marketed.For the specific requirements you may refer to the page of Disinfector Licensing or consult to the ZOOP’s counselor.

 

三、Required Documents

NO.

Document Name

Notes

01

Application form of Hygiene License of Disinfection Product Manufacturer

prepared by ZOP

02

Copy of business license or notice of pre-approval of enterprise name

provided by client

03

Proof of use of production site (housing ownership certificate or lease agreement)

provided by client

04

The floor plan of the production site and the layout of the production workshop

provided by client and ZOOP will advise.

05

Flow chart of production process

provided by client

06

Production and inspection equipment list

provided by client

07

Documents of Quality Assurance System

ZOOP will provide the template and guide the client to make out.

08

Catalog of products to be produced

 

ZOOP will confirm based on customer's actual production plan

 

09

Test report of production environment and production water supply

ZOOP will assist the customer in finding a third-party inspection institution.

10

Copy of production hygiene license of upstream semi-finished product manufacturer

The customer shall find the upstream partner to provide (for the sub-assembly production)

11

Sub-assembly and Processing Agreement (with upstream manufacturers)

provided by client(for sub-assembly)

12

The upstream semi-finished product manufacturer's letter of commitment to product quality

Provided by upstream semi-finished product manufacturer(for sub-assembly)

13

Other materials requested by provincial health authorities

ZOOP will advise based on local requirements.

Notes:Please make sure that the above item 03,06 can be provided and the rest can be prepared according to ZOOP's guidance.

The above are only the most basic requirements. The specific requirements will vary depending on where the factory is located and the product category to be declared. Please consult the front-end consultant of ZOOP for details.

 

Professional Services from ZOOP

1. Plant and workshop planning.

2. Proposal for application of product category (item).

3. To plan the basic personnel requirements, personnel qualifications and quantity for the license application required.

4. Advice on equipment (ZOOP does not provide advice on product development and process, but will give reasonable advice on equipment requirements in accordance with regulatory ).

5. Provide document templates of the quality management system, and assist in establishing the system (for passing the examination of the regulatory department).

6. ZOOP will train one or two people on regulations to pass the health commission's on-site review.

7. Guide the client to prepare the declaration materials, pre-review the materials provided by the client and standardize.

8. Compile a whole set of application materials and submit to the Health Commission to obtain license.

9. Provide technical support to the questions raised by the Health Commission during the application process.

10. Follow up the entire review process until the license is obtained.

11. Provide clients with routine consultation on license usage.

12. After obtaining the license,service of record-filing is available for the product produced(additional charges).