In vitro diagnostic instrument core parts production need production license?

According to the relevant information query: need. In vitro diagnostic instrument core parts production to be submitted to the relevant level of drug supervision department for approval, get a production license before the enterprise can go into production, usually takes about a year and a half, in vitro diagnostic reagents belong to the medical device products (hereinafter referred to as "IVD"), refers to the use of a separate or with the combination of instruments, appliances, equipment or systems.