How can the contraindications in the instructions of listed medical devices be changed?
A.
If there are changes to the taboo signs and other contents beyond the items specified in the registration certificate and its attachments, the registrant can apply for changes by submitting a notice of change in the instruction manual.
Q.
Is it feasible to divide the acceptable limits of bending strength and equivalent bending stiffness of metal bone plate products directly according to the thickness interval?
A.
The length, width, thickness, aperture, number of holes, distribution of holes and surface treatment of metal bone plates may affect the bending performance of bone plates, and should be taken into account when setting acceptable limits of performance indicators, rather than just the thickness of bone plates.
