In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents III

2. Molecular Diagnostic Instruments

In 2020, NMPA approved 18 types of class III molecular diagnostic instruments, and the provincial medical product administration approved 11 types of class II molecular diagnostic instruments, a total of 29. In 2021, 19 types of class III molecular diagnostic instruments were approved, and 25 types of class II molecular diagnostic instruments were approved by the provincial medical product administration, with a total of 44 types. The obvious increase in 2021 compared with 2020 may be the result of the NMPA’s accelerated approval in response to the epidemic.

The above instruments are classified according to their uses. In 2020, seven fluorescent PCR instruments, three PCR amplification instruments, one nucleic acid extraction and detection system, three nucleic acid extraction and PCR setup systems, one chip analyzer, three hybridization instruments, six sequencing instruments, two isothermal amplification instruments, one capillary electrophoresis gene analyzer, and three POCT instruments were approved. In 2021, 10 fluorescent PCR instruments, seven PCR amplification instruments, one sequencing sample preparation system, two nucleic acid extraction and amplification system, four nucleic acid extraction and PCR set-up system, 11 chip analyzers, two hybridizers, two sequencers, four isothermal amplification instruments, and one microfluidic nucleic acid amplification instrument were approved. Compared with 2020, more types of instruments were added in 2021, including fluorescent PCR instruments, PCR amplification instrument, nucleic acid extraction, PCR set-up system, isothermal amplification instrument, and chip analyzers.

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