Medical Device Act 2012 s 3
s 3 Classification of medical device
(1) A medical device shall be classified by an establishment based on the level of risk it poses, its intended use and the vulnerability of the human body in accordance with the prescribed manner.
(2) In the event of any dispute between an establishment and a conformity assessment body over a classification of a medical device, the matter shall be referred to the Authority, in the manner and within such period as may be specified by the Authority, for its decision.
Malay text (authoritative)
Pengkelasan peranti perubatan
(1) Sesuatu peranti perubatan hendaklah dikelaskan oleh sesuatu establismen berdasarkan tahap risiko yang ditimbulkan olehnya, penggunaan yang diniatkan baginya dan mudahnya tubuh manusia terdedah pada bahaya mengikut cara yang ditetapkan.
(2) Sekiranya berlaku apa-apa pertikaian antara suatu establismen dengan suatu badan penilaian pematuhan mengenai pengkelasan sesuatu peranti perubatan, perkara itu hendaklah dirujukkan kepada Pihak Berkuasa, mengikut cara dan dalam apa-apa tempoh yang ditentukan oleh Pihak Berkuasa, bagi keputusannya.
Read this section in the full act → · Open Chapter 1 →
Find Act 737 on lom.agc.gov.my ↗
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).
