41EK
CurrentConditions imposed when conformity assessment certificates are issued
Volume 2s 41B-Endnotes
Chapter 4Medical devices
Part 4-4Conformity assessment certificates
Division 2Conditions
41EK Conditions imposed when conformity assessment certificates are issued
If the Secretary issues a conformity assessment certificate in respect of a manufacturer, the Secretary may, in writing, impose conditions on the certificate in respect of:
(a)
one or more kinds of medical devices covered by the certificate; or
(b)
the manufacturer’s quality management system.
This Act’s bill:Second reading speech
Research tools for this sectionSubscription
The statute text is free to read above. View subscription options to unlock the case-law research tools for each provision.