Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part II, Registration of Medical Device and Conformity Assessment Body, Chapter 1, Registration of medical device.
5. REQUIREMENT FOR REGISTRATION OF MEDICAL
(1) No medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.
(2) Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding Two Hundred Thousand Ringgit (RM200,000) or to imprisonment for a term not exceeding Three (3) years or to both.