Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part III, Licence and Permit, Chapter 2, Designated medical device permit.

27. REQUIREMENT FOR DESIGNATED MEDICAL DEVICE PERMIT

(1) No person shall use or operate any designated medical device unless the person holds a designated medical device permit granted under this Act.

(2) Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding One Hundred Thousand Ringgit (RM100,000.00) or to Imprisonment for a term not exceeding One (1) years or to both.

Source: LAWS OF MALAYSIA, Act 737, Medical Device Act 2012.