The draft order was developed to implement the Procedure for the manufacture, quality control, and circulation of bioimplants, approved by the Cabinet of Ministers of Ukraine dated February 24, 2021, № 158.
The draft order proposes to approve:
1) The procedure for keeping records of manufacturers and authorized representatives responsible for the introduction of bioimplants, the form of notification, the list of information stored in it, and the mode of access to them;
2) The procedure for conducting inspection and control measures for compliance with the requirements of the organization of the quality system in the institution that provides anatomical materials;
3) the form of the Notice of commencement of activities for the extraction of anatomical materials from the donor-corpse for the manufacture of bioimplants, storage, and transportation;
4) the form of the Notification of a serious adverse reaction;
5) the form of the Notice of recall of anatomical materials from the manufacturer of bioimplants;
6) the form of the Information on confirmation of a serious adverse reaction;
7) the form of the annual report on the activities of the institution that provides anatomical materials.