Approval for Innovative Medical Device’s Special Review and Priority Review in the First Half of 2019

After the intensive NMPA review, 7 IVD products from 7 companies successfully passed the CMDE review in the first half of 2019 (January- Jun 2019). These companies are Huada Biotechnology (Wuhan) Co., Ltd., Shanghai Rendu Biotechnology Co., Ltd., Hangzhou Ustar Biotechnology Co., Ltd., Baicare (Tianjin) Biotechnology Co., Ltd., Beijing Hotgen Biotechnology Co., Ltd., Suzhou Sym-Bio Life Science Co., Ltd., and Dako North America, Inc.
The results of priority review and special review for innovative medical device as follow:
No. Issuing Time Acceptance No. Product Name Applicant
1 2019/2/28 CSZ1900042 Hereditary deafness gene detection kit (combinatorial probe-anchor synthesis sequencing) Huada Biotechnology (Wuhan) Co., Ltd.
2 2019/4/10 CSZ1900102 Hepatitis B virus nucleic acid assay kit (RNA probe capture method) Shanghai Rendu Biotechnology Co., Ltd.
3 2019/5/27 CSZ1900160 Mycobacterium tuberculosis nucleic acid detection kit (isothermal amplification - real-time fluorescence method) Ustar Biotechnology Ltd.
4 2019/6/13 CSZ1900198 Respiratory pathogen nucleic acid detection kit (isothermal amplification chip method) Tianjin Baicare Biotechnology Co., Ltd
5 2019/6/24 CSZ1900206 Hepatitis B virus pgRNA (HBV-pgRNA) assay kit (PCR-fluorescence probe method) Hotgen Biotech Co., Ltd
6 2019/6/28 CSZ1900199 Newborn screening for non-derivative multiple genetic metabolic diseases (mass spectrometry) Suzhou Sym-Bio Life Science Co., Ltd.
No. Acceptance No. Product Name Applicant
1 JSZ1800126 PD-L1 detection kit (immunohistochemical method) Dako North America, Inc.

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