In vitro diagnostic reagent production implementation Rules (trial) (State Food and Drug Administration [2007]239) since 2007 began to implement in 2011 began to implement the" sterile and implanting medical device production quality management practice ", 2014 announcement No. 64, the State Administration revised the "Medical device production quality Management practice", July 2015, The State Administration of China has successively issued the Announcement of In Vitro Diagnostic Reagents for Medical Device Production Quality Management Appendix, the Announcement of Sterile Medical Device Production Quality Management Appendix, and the Announcement of implantable Medical Device Production Quality Management Appendix. Further strengthen the production quality requirements of aseptic, implantable and in vitro diagnostic reagents. In the daily supervision process, it is found that the construction of clean delivery rooms in some enterprises is not standardized enough. Therefore, the construction requirements of clean workshops are proposed as follows: