Medical device company sold reagents counted over the scope of business

Medical device company sold reagents is considered over the scope of business. According to the query Oriental medical equipment network shows that the sale of reagents need to have a drug sales license, medical equipment companies usually only "medical equipment business enterprise license", only according to the voucher on the business scope of the medical equipment class, sold reagents even if the scope of operation, need to be punished according to the "medical equipment business enterprise license management approach".