General Director of Food and Drug Administration: released 4 medical device guidelines

On Feb. 24, CFDA released the "Circular of the General Administration of Quality Supervision, Inspection and Quarantine on the Guidelines for the Examination of 4 Registered Technologies for Examination of Genes Relating to Epidermal Growth Factor Receptor Mutation (No. 36 of 2018)".

The circular said to be strengthened medical instruments Product registration supervision and guidance to further improve the quality of registration examination, national food drug The State Administration of Supervision and Management has formulated the Guiding Principles for the Examination of Technology for Registration of Human Epidermal Growth Factor Receptor (EGFR) Mutant Gene Detection Reagent (PCR Method), Guiding Principles for Examination Technical Guidance for Registration of Helicobacter Pylori Antigen / Antibody Detection Reagents, Guidelines for the Examination of Registration Reagents for Detection Reagents ", Guidelines for Review of Technology for Registration of Enteroviral Nucleic Acid Detection Reagents are hereby promulgated.

The guidelines are the general requirements for the corresponding test reagents, the applicant should be based on the specific characteristics of the product to determine the content and the specific characteristics of the product registration information to enrich and refine the content.

For the registration of the above four test reagents, the author of the current domestic registered manufacturers were analyzed:

1. Human Epidermal Growth Factor Receptor Test Reagents - There are 2 domestic enterprises that have obtained the approval of registration, namely Beijing Shengfa Xing Biotechnology Co., Ltd. (Guomin registration 20163400152) and Beijing Dacheng Bioengineering Co., Ltd. Prospective 20153401262), Beijing Shengfa's registration approval expires in January 2021, and Beijing Dacheng expires in July 2020. However,

Beijing Sheng Fat Xing Biotechnology Co., Ltd., the main biotechnology research and transfer, June 16, 2017 before the domestic-funded enterprises, and later changed to foreign-invested enterprises.

Beijing Beijing Dacheng Bioengineering Co., Ltd., Hong Kong Dacheng International Investment Group, a subsidiary of the main new technologies: automatic magnetic particle chemiluminescence immunoassay system and high-sensitivity plate chemiluminescence immunoassay system.

2, Helicobacter pylori antigen / antibody test reagent - There are 4 domestic enterprises to obtain the registration approval, which are respectively Beijing Chur Technology Co., Ltd. (State Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, 20153401675, valid until 2020.09.14), Concord Pharmaceutical Co., Ltd. State Food and Drug Administration (quasi) word 2009 No. 3401036, valid until 2013.12.29), Aikang Biotechnology (Hangzhou) Co., Ltd. (Guoliao 20163400545, valid until 2021.03.15), Shenzhen Health Biotech Limited Company (State-owned registration 20153400368, valid until 2020.02.26).

Beijing Chur Technology Co., Ltd., a multinational corporation headquartered in California, USA, manufactures and distributes in vitro diagnostic reagents.

Concord Pharmaceutical Co., Ltd., research and development, production and sales of drugs and Healthy food Modern GMP pharmaceuticals.

Aikang Biotechnology (Hangzhou) Co., Ltd., a wholly foreign-owned biotechnology company founded by Chinese Americans in America, covers three major industries of in vitro diagnostic reagents, medical devices and medical electronics.

Shenzhen Kang Sheng Bao Biotechnology Co., Ltd., under the Hong Kong Chen Hing Group and Hong Kong Kaikang Holdings Limited, specializes in in vitro diagnostic reagents research and development, production and sales.

3, anti-human globulin test reagents - registered domestic approval of the two enterprise , Jiangyin force Bo medicine Biotech Co., Ltd. (State Food and Drug Administration (Associate) 2012 No. 3400942, the registration approval has expired) and Shanghai Blood Biopharmaceutical Co., Ltd. (State Food and Drug Administration (prospective) 2012 No. 3401424, the registration Approval has expired)

Jiangyin Libang Pharmaceutical Biotechnology Co., Ltd. is a science and technology enterprise dedicated to the research and development, production and sales of related products such as blood type testing and tumor testing.

Shanghai Blood Biomedical Co., Ltd. focuses on the research and development, production and sales of blood type diagnostic reagents, as well as consulting on related technologies.

4, enterovirus nucleic acid detection reagent - registered in the country to obtain approval of only one enterprise, Jiangsu Merlot Biotechnology Co., Ltd. (State registration Note 20143402367, valid until 2019.12.30)

Jiangsu Merlot Biotechnology Co., Ltd., engaged in biomedical, biological products, biotechnology research and development, technology consulting and technology transfer business, the company in 2010 has been approved for the production of enterovirus nucleic acid test reagents (State Food and Drug Administration Machinery (quasi) word 2010 No. 3401300), this batch of documents for the change of approval.