"On-site Review Standards" applies to the city's in vitro diagnostic reagent manufacturers to start, change and renew the license on-site scoring, in vitro diagnostic reagent manufacturers is a special review of standards. Compared with the general production enterprise on-site review scoring standards, mainly in the personnel, production sites and equipment and other hardware requirements, the review of each part of the project score and other aspects of the adjustment and further clarification.
Beijing Municipal Drug Administration also according to the city's medical device manufacturer supervision requirements, further clarified the in vitro diagnostic reagent enterprises to apply for the preparatory work, clean room environment testing institutions, license production scope of the approved requirements and other content.
The implementation of the "on-site review standards" will further strengthen the Beijing in vitro diagnostic reagent manufacturers access threshold, standardize the production of in vitro diagnostic reagents, in vitro diagnostic reagents for the "in vitro diagnostic reagent registration management approach (for trial implementation)" and the implementation of the quality system to carry out the assessment to lay the foundation.