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.

16. APPLICATION FOR ESTABLISHMENT LICENCE

(1) An establishment may apply for an establishment licence to be granted under this Act by submitting a written application to the Authority in the prescribed manner.

(2) Every application under subsection (1) shall be accompanied by the prescribed application fee and such document or information as may be specified by the Authority.

(3) An application may be withdrawn at any time by the applicant before it is granted or refused by the Authority.

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