Section 38
Post-market surveillance and vigilance
ActIn forceProvision 38 of 80
Section 38
(1)
An establishment shall monitor the safety and performance of the medical device manufactured, imported, exported and placed in the market, and put in place a post-market surveillance system as prescribed by the
Minister.
(2)
An establishment shall ensure that any vigilance report of adverse incident involving its medical device in the market is properly recorded and fully evaluated.