Gene sequencing diagnostic related products required to register and approve in China from 9th February 2014

14th Jan. 2014, CFDA issued the notice (No. 2014-8 ) on medical device classification decision, it is firstly clarified that all Gene sequencing diagnostic products (including gene sequencing equipment, related diagnostic and software) must be managed as medical device in China. Any companies relevant to gene sequencing diagnostic products would be affected, they are required to apply for and obtain the appropriate application approval for their products before manufacture, import, distribute or use according to the CFDA notice (No. 2014-25) on 9th Feb. 2014.
The Gene sequencing diagnostic related products include the all gene sequencing product and technology (including gene sequencing equipment, related diagnostic reagent and software) for gene diagnosis, it can be used for disease prevention, diagnosis, monitoring, treatment evaluation monitoring, health status evaluation and genetic disease prediction by in-vitro testing on human body specimen. It meets the definition of medical device, so it must be managed as medical device and approved by CFDA and NHFPC (National Health and Family Planning Commission of the People’s Republic of China, former known as MOH) unless only used for research and development and not for clinical use.
In general, the genetic testing equipment and related diagnostic are managed as class III medical devices, the software for genetic diagnosis or monitoring is managed as class II medical devices and the gene sequencing reagent kit as class I medical devices. Companies shall apply for the medical device registration certificate for your product by grouping or single product with correct classification from CFDA.