The national health and family planning commission (NHFPC) will advise on the provisions of the provisions of five normative documents, including the regulation of new sterilization products and the administration of health administrative licensing for new water products

Release time: 2017-05-27

The national health supervision issue (2017) 27

Provincial, autonomous regional and municipal health and family planning commission, xinjiang production and construction corps health bureau, CDC and monitoring center:

According to the state council on the second batch of clear specification 192 items of administrative examination and approval department of the state council decisions on matters affecting the intermediary services (guo fa [2016] no. 11), the central for 25 items specified local implementation of the intermediary services and other items of administrative examination and approval notice (to check and revise do hair [2017] no. 1) requirements as well as the national health and family planning commission party about the national center for health and family planning commission health supervision and family planning related responsibilities to adjust to the actual situation of the Chinese center for disease control and prevention, after cleaning, the decision will be modified for the following parts of the regulatory documents.

1, "new disinfection products and the regulations for the administration of public health administrative licensing for new water products" (national health office supervision, 2014) 14)

(1) the "health supervision center" in article 4, 10, 11 and 18 has been amended to be "the Chinese center for disease control and prevention".

(2) of article 12 is revised as follows: "in the process of technical review review committee thinks need to the test results and the test method (or evaluation method) for validation test, by the review committee to determine the product validation inspection items, inspection method, inspection sample request and whether the sample sealing. Validation test the examination and approval departments shall entrust the qualification cognizance of the inspection institution."

(3) of article 14 is revised as: "undertake inspection institution to receive samples for validation test sample products, should be to check samples, seals and sampling list, etc, seal the damaged samples will not be received.

Issued by the inspection agency inspection report shall be 6 color photographs, inspection application form, to accept the advice, product manuals, sample orders, all materials need to page affixed with a special seal for inspection. ""

(four) will annex 1 new disinfection product filing acceptance regulation of article 2 of "health supervision center online declaration system" is amended as: "national health family planning permission by the health administrative online declaration system".

Delete the attachment 1 "declare to accept the new disinfection products sets" (5) of article 9, article 10 (3) and (2) of article 11 of the "Chinese translation shall be notarized at the notary office in China".

(5) will annex 2 new wading product declare to accept the regulation of article 2 of "health supervision center online declaration system" is amended as: "the national health and family planning commission health administrative licensing online declaration system".

Delete the attachment 2 new wading product filing acceptance regulation article 10 (5), article 11 (3), article 12 (2) in the "Chinese translation shall be notarized at the notary office in China".

Second, the sanitary standards for the production of sterilized products (2009 edition).

Article 46 in the first paragraph is revised as follows: "enterprises shall strictly in accordance with the relevant state standards, strengthening sterilization products directly engaged in production operators of health management."

Third, the sanitary regulations for the production enterprise of disinfecting products (who supervises the issue of the 110)

(1) revise the article 14 (6) to: "the inspection personnel, the health management personnel and the personnel training certificate."

(2) of article 23 is revised as follows: "lost hygiene license, it shall timely apply for reissue to the provincial health administrative department. Reissue hygiene license to use the original hygiene license, approval date to allow replacement date, printed with the words" replacement ", after the date in the original expiration date remains the same."

Iv. The regulations for the administration of public health administration of water products under the provincial government (national health office supervision issue, no. 63)

(1) of article 21 is amended as: "application continues, alteration, cancellation and reissue sanitary administrative licensing, approval documents shall be indicated in the approval documents by the applicant to file an application with the original license issuing and filing materials according to the provincial wading product requirements, submit relevant materials, and shall be responsible for the authenticity of the application materials, and bear corresponding legal responsibilities.

If the application for the approval of the approval of the issuance of a license is issued, the supplementary application form shall be submitted. Replacement hygiene license to use the original hygiene license, approval date to allow replacement date, printed with the words "replacement", after the date in the original expiration date remains the same. ""

Delete attachment 1 (2) in article 2 of the provincial wading product declaration material requirement (8), (4) of article 5, article 7 (5) and (3) of article 9, article 10 (3), (5) of article 21 and article 22 (2) in the "Chinese translation shall be acknowledged by the notary office of China".

To delete annex 1, article 11 of the requirement for the application of the application for the declaration of water products in the province.

Five, "regulations on the administration of radiological health technology services" (who supervises hair [2012] no. 25)

Article 24 is revised as follows: "lost of radiological technology service agency qualification certificate, shall be promptly to the provincial health administrative department to apply for reissue. Replacement of radiological technology service agency qualification certificates in use the original number, date of approval to allow replacement date, printed with the words" replacement ", after the date in the original expiration date remains the same."

The national health and family planning commission

On May 9, 2017