Chinese Disinfectant Product Regulations

On July 13^th 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 23^th 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. 10^th 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. 11^th 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. 20^th of 2013.
Table 1 Regulatory Obligation for Disinfection Products

To further strengthen the supervision on disinfection product, NHFPC formulated and released the draft version of “Health Supervision Norms for Disinfection Products” (referred to as “Norms”) which according to officials will be published in July of 2014. Under the provisions of “Norms”, supervision on disinfection products will be implemented according to the inherent characteristics of the product, the products uses and the degree of risk associated with the product. Disinfection products including disinfectants, disinfecting devices and sanitary products are divided into three categories: 1) Disinfection products with high risk and requiring strict supervision e.g. disinfectants and sterilizing agents used for medical devices, disinfectants used for skin and mucosal surfaces, and disinfecting devices, chemical and biological indicators used for medical devices; 2) Disinfection products with medium risk and requiring increased supervision, referring to those disinfectants, disinfecting devices and anti-bacteria agents which are not covered in the first category; 3) Disinfection products with low risk and requiring regular supervision, referring to the sanitary products excluding anti-bacteria agents.
 
In spite of regulatory reforms the procedures for practical regulatory compliance remain unclear. Reach24h attended the training courses on “New Disinfection Products License” sponsored by China Health Supervision Magazine from June 11^th to 12^th of 2014.
 
The following points list the most relevant issues facing industry
 
1) Amendment of “Catalog of Disinfection Product” (Referred to “Catalog”) is under discussion. One of the main reasons for “Catalog” amendment is the lack of a legal definition of disinfection products. The “Catalog” currently in use was revised in 2002 and is therefore inadequate to meet the demands of the modernized regulatory framework. Moreover, illegal use of drugs such as antibiotics detected in the routine sample inspection for disinfection products along with the difficulties encountered in differentiating between medical devices and disinfecting devices have prompted regulators from NHFPC to think about turning over regulatory responsibility of certain product categories to other authorities.
 
1.      New disinfection product registration
Since the regulatory updates, there have been no applications for registration of new disinfection products. Some of the implementation details are still under discussion. For example, the registration certificate is extremely important for manufacturers in order to show it to the purchasers marketing their products. Therefore, “certificate forgery” and “one certificate, multi-products” as well as other acts in violation of regulations are often found. To regulate the disinfection products market, a new document will be issued to replace the registration certificate. The format of this document is still being discussed
 
2.      Hygiene and safety assessment report for existing disinfection products
Unlike what’s laid down in the consultation draft of “Provisions on Assessment”, only the first and second categories of disinfection products need an assessment report which can be done by the manufacturer itself or a third party. What’s more, there is a four-year validity period for the assessment report of the first category product. Hence, prior to the assessment expiration date, manufacturers must perform the test and produce an assessment report again. To guarantee the quality of products used in sample testing, when conducting the hygiene and safety assessment, samples should be collected on site by personnel from the provincial center for health inspection and supervision. This rule is likely to be changed as officials are not in favor of personally collecting the samples themselves.
 
3.      Issues detected during inspection
One of the main issues detected during inspection are inconsistencies in submitted registration materials and the actual production process utilized by manufacturers. Common problems include “One certificate and multi-products”, illegal use of prohibited substances such as antibiotics, etc.
 
4.      Future Supervision of Disinfection Products
Future supervision work will primarily focus on reinforcement of supervision of existing disinfection products, improvement of the ability of the supervisors at provincial and regional levels, and innovation of regulatory approaches.
 
The development of China’s disinfection management framework has been largely realized with the implementation of numerous new regulatory reforms, the reduction of administrative approval requirements, and an increase in post-market supervision. Although a reduction in administrative approval for certain product categories has decreased the regulatory burden on industry this reform has come in tandem with an increase in the requirements for safety testing and assessment of other product categories. The net change in regulatory requirements is minimal however now China has a modernized and more rational approach to regulate disinfectant products.