Medical Device Act 2012 s 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.
Pemantauan dan pengawasan pascapasaran
(1) Sesuatu establismen hendaklah memantau keselamatan dan prestasi peranti perubatan yang dibuat, diimport, dieksport dan diletakkan dalam pasaran, dan menyediakan suatu sistem pemantauan pascapasaran sebagaimana yang ditetapkan oleh Menteri. (2) Sesuatu establismen hendaklah memastikan bahawa apa-apa laporan pengawasan mengenai insiden yang memudaratkan yang melibatkan peranti perubatannya dalam pasaran direkodkan dengan sewajarnya dan dinilai sepenuhnya.
Text as at 1 March 2017 (LOM reprint); amendments made after that date may not be incorporated.
Source: Laws of Malaysia, Attorney General's Chambers of Malaysia (lom.agc.gov.my). Not a copy of the Gazette printed by the Government Printer (Interpretation Acts 1948 and 1967, s 61).