On July 13th of 2013, the State Council released Circular No. 27 “Decision on Cancellation and Decentralization of 50 Items of Administrative Approval” in which disinfection products were also listed. Subsequently on 23th of the same month, NHFPC (National Health and Family Planning Commission) issued announcement No. 1 of 2013 on “Cancellation and Decentralization of Part of the Administrative Approval for Disinfection and Aquatic Products”. According to the announcement, administrative approval of disinfectants and disinfecting products not produced by the use of new materials, new technologies and new principles of sterilization was cancelled.
To strengthen the supervision over disinfection products, NHFPC released Announcement No. 18 of 2013 on Further Reinforcement on Supervision of Disinfection Products in Sep. of 2013. This announcement requires that responsible units conduct the hygiene and safety assessment for disinfectants, disinfecting devices and anti-bacteria agents as well as other existing disinfection products that do not require administrative approval prior to market release, so as to guarantee the hygiene and quality of the products. The “Provisions on Hygiene and Safety Assessment of Disinfection Products” (2009 version) currently in effect is only applicable to six types of disinfection products and is not able to fully regulate the industry. Therefore, on Jan. 10th of 2014, NHFPC amended and released the draft version of the “Provisions on Hygiene and Safety Assessment of Disinfection Products” (referred to as “Provisions on Assessment”) which will implemented in the near future.
As to the administrative approval of new disinfection and aquatic products, on Feb. 11th of 2014, NHFPC released the “Provisions on Administrative License of New Disinfection and Aquatic Products.” The provisions include 30 articles in 4 chapters, which clearly stipulate the requirements of content, time limit, application acceptance criteria, examination and determination. The provision annexes also details the application procedures, documents and other materials required. NHFPC will periodically announce disinfection products which have been newly registered. After announcement products do not need to be registered anymore. NHFPC also released the “Provisions on Application and Acceptance of New Disinfection Product Registration” which stipulates the requirements on application and the registration materials.
Therefore, currently, there are two compliance requirements associated with disinfection products, one is registration of new disinfection products and the other is hygiene and safety assessment of non-new disinfection products (See table 1 for details). New disinfection products are decided based on the “Criteria for Determining of Disinfectants and Disinfecting Devices Produced by the Use of New materials, New Technology and New Principle of Sterilization” (hereafter referred to as “Criteria”) which was launched by NHFPC on Dec. 20th of 2013.
Table 1 Regulatory Obligation for Disinfection Products