Sterilization product filing process sterilization product filing

What materials are needed for the autoclave filing?

The autoclave test filing to find a professional and reliable third-party disinfection product testing and filing institutions, testing organizations need to have CMA certification, the need to pass the laboratory accreditation, can be based on the requirements of the relevant disinfection product testing standards, in strict accordance with the standard requirements of the test project testing, the issuance of a reliable CMA inspection report for health and safety evaluation report.

Application for CMA inspection and testing accreditation need to submit information:

(1) application for accreditation of inspection and testing

(2) typical test reports (1 for each category)

(3) quality manuals, procedural documents

(4) business license (the scope of business should include inspection and testing business, and shall not include the scope of the design, research and development, production, sales, etc.) (4) business license (business scope should include inspection and testing business, shall not include the design, research and development, production, sales, etc.) (non-independent legal laboratories need to provide laboratory set up approvals)

(5) authorization letter of legal representative (non-independent legal laboratories, legal representatives are not involved in laboratory management)

(6) property rights of the fixed place / right to use the documents (the laboratory's real estate license or housing lease contract, the submission of housing lease contract at the same time need to submit the lessor's property rights)

(7) the business license (the business scope should include testing business, shall not contain design, research and development, production, sales and other scopes) (7) management system internal audit, management review records (need to be in the management system formally and effectively run 6 months before the internal audit, management review)

(8) testing / calibration equipment independent deployment of documents (such as invoices for testing equipment, equipment bidding documents, etc.)

(9) professional and technical staff, management personnel labor relations certificate (Social security department stamped confirmation of social security details, labor contracts)

(10) professional and technical personnel qualifications (the technical director and authorized signatory should have the title of engineer and above or equivalent ability)

(11) testing operators training induction certificate (engaged in special testing/calibration of business personnel should provide the appropriate proof of qualifications, such as: non-destructive testing personnel need to provide (Nondestructive testing certificate)

Autoclave testing for the record to find which organization to deal with?

Autoclave sterilization pots and other disinfection products need to apply for the record for the record, testing and filing need to look for authoritative and CMA certification of the third-party testing organizations, in the detection of autoclave autoclave testing and filing center is trustworthy.

Disinfection products for the record how to query the certificate?

Consumption of the size of the need for the Department of Health for the record, the record can be successful in the national disinfection products web link above the query.

The first category, the second category of disinfection products before the first market should be carried out health and safety evaluation, health and safety evaluation of qualified disinfection products can be marketed.

Sanitized products of health and safety evaluation report can be on their own on the national disinfection products online filing information service platform to check whether the product is filed, but also can download the disinfection product inspection report.

National disinfection products online record query official website?

One we open the "national disinfection products online filing information service platform" (URL: / xdcp/loginPage.do)

Select the disinfection products responsible for the unit query, and then in the search box below enter: Shandong Huashi Pharmaceutical Co. Ltd. is the manufacturer of Xuba chlorine dioxide disinfectant), click the "Search" button.

Three click on the blue font "Shandong Huashi Pharmaceutical Company Limited"

Four can view all the platform of Shandong Huashi Pharmaceutical filed products, we click on the Xuba brand chlorine dioxide disinfectant powder II this link to view the product's record information.

Five we can see the product labeling, inspection reports, disinfection products, such as health permits and other qualifications are very complete, is a product that can be trusted to buy.

Consumer products online record how?

One, the consumer needs to be in the Department of Health for the record, the record can be successful in the national disinfection products web link above the query, the query is successful that is legal consumer products.

Second, the record process:

1, to determine the nature of the product belongs to the antimicrobial products or disinfection products.

2, to determine whether the composition of the product is in line with national standards, remember not to add Western medicine and hormone components.

3, according to the basic information of the product to draft the consumer product information (as the consumer test basis).

4, prepare samples for testing (the consumer testing cycle is generally 3-4 months).

5, the record security assessment report.

6, network filing.

The first category of disinfection products: high-level disinfectants and disinfecting instruments for medical devices, sterilizing agents and sterilizing instruments, skin / mucous membrane disinfectants, biological indicators, chemical indicators of sterilization effects; the second category of disinfection products: in addition to the first category of products, disinfectants, disinfecting instruments, chemical indicators, and packaging with sterilization marking of sterilized items, anti (antibacterial) agents. Sterilization products responsible units in the first and second category of disinfection products before the first market need to carry out health and safety evaluation.