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New coronavirus antigen test reagent belongs to the third class of medical equipment products, need to obtain the State Drug Administration of the medical device registration certificate. As of December 11, 2022, the People's Daily Health Client reporter was informed that the new coronavirus antigen test reagents approved by the State Drug Administration through the audit of the market has reached a total of 40 models.

In addition to the recently approved base egg biology, Baioda Biotechnology, Taipu Bioscience, Zhongshan Bioengineering Co., Ltd. 4 in addition, the State Drug Administration also issued on December 8, "on the extension of the validity of the registration certificate of the new coronavirus antigen test reagents notice" (No. 114 of 2022), will have been approved for registration of the new coronavirus antigen test reagents of the validity of the certificate of registration in the original validity basis On the basis of the original validity period to extend six months, to effectively protect the market supply of related products.

According to the national in vitro diagnostic network CAIVD statistics, China's 40 approved new coronavirus antigen test reagents can be divided into three categories, respectively, colloidal gold, latex and fluorescent immunochromatography. Among them, fluorescence immunochromatography requires the use of professional testing equipment, is not suitable for residents at home self-testing, so the general self-testing kits at home are colloidal gold and latex kits.

Among them, the colloidal gold method has the most products, there are 28 models, respectively, from Guangzhou Wanfu Biological, Nanjing Novozymes, Beijing Thermal King Biological, Beijing Wantai Biological, Tianjin Booseth, Beijing Lepu Medical, Chongqing Mingdao Jiejie, Wuhan Mind Biological, Zhejiang Orient Genetics, Chongqing Zhongyuan Huiji, Shandong Kanghua Biological, Xiamen AoDe Biological, Shenzhen Yafei Long, Beijing Zhuo Cheng Huisheng, Nanjing Shenji Pharmaceuticals, Shanghai Xinchao Bio, Shandong Boke Diagnostics, Shanghai Berger Medical, Fosun Diagnostics, Wuhan Shengzhiyuan, Shanghai Kehua, Xiamen Baotai, Zhijiang Bio, BioOrganics, Jiangsu Meike, Baioda Bio, Taipu Bio, Zhongshan Bioengineering Co.

There are 9 products using the latex method, respectively, from Beijing Jinwuofu, Hangzhou Aotai Bio, Aikang Bio, Innotek, Zhuhai Lizhu Reagent, Jingshuo Bio, Haihatch Medical, Wuxi Kezhida, and Kiwi Bio.

In addition, there are 3 new coronavirus antigen detection reagents by fluorescence immunochromatography from Shenzhen Huada Ingenics, Beijing Huakotai, and Shenzhen Yirui Bio.

On March 30, 2020, the State Drug Administration issued "China's regulatory requirements and standards for new coronavirus detection reagents and protective equipment", new coronavirus detection reagents as a third class of medical device management.

In March 2022, the State Drug Administration issued the "Notice on Doing a Good Job of Quality and Safety Supervision of New Coronavirus Antigen Test Reagents", which requires that retail pharmacies and medical device companies that have obtained a drug license or a medical device license and have the appropriate storage conditions be allowed to sell new coronavirus antigen test reagents.

In addition, a number of approved antigen manufacturers such as Aflac Bio, Zhongyuan Huiji, Heat King Bio, Berger Medical, BaoTai Bio, Novozymes Bio, etc. have issued a statement on further standardization of operations, calling on the distributor partners to strictly comply with laws and regulations and abide by the business ethics of sales with a medical device license or a drug license, and at the same time the need to strictly implement the State Administration of Market Supervision's "Guidelines on the implementation of the new coronavirus antigen testing reagents". Implementation of the State Market Supervision and Administration of the price of epidemic-related materials and the order of competition to remind the cautionary letter "requirements, strictly abide by the" nine shall not "red line, in accordance with the law and reasonable price setting, is strictly prohibited to inflate the price of each other collusion to manipulate the market price, disrupting the order of the market price.