Skip to content
mylaw.my

Section 4

Manufacturer’s obligations

of Medical Device Act 2012

ActIn forceProvision 4 of 80
Section 4

A manufacturer shall ensure that a medical device—

(a)

conforms to the prescribed essential principles of safety and performance;

(b)

is manufactured in accordance with good manufacturing practice and any written directive issued by the Authority; and

(c)

is labelled, packaged and marked in accordance with the prescribed manner.

Read in full context — Medical Device Act 2012 →