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 1, Establishment Licence.

15. REQUIREMENT FOR ESTABLISHMENT LICENCE

(1) No establishment shall import, export or place in the market any registered medical device unless it holds an establishment licence granted under this Act.

(2) An establishment who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding Two Hundred Thousand Ringgit (RM200,000.00) or to Imprisonment for a term not exceeding three (3) years or to both.

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