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.

6. APPLICATION FOR REGISTRATION OF MEDICAL DEVICE

(1) An application for the registration of a medical device shall be made by an establishment to the Authority in the prescribed manner.

(2) An application may be withdrawn at any time by the applicant before it is approved or refused by the Authority.

(3) 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.

(4) The Authority may, in writing, at any time after the receipt of an application under subsection (1), request the applicant to give to the Authority within the period specified in the request additional information, particulars or document on the application or sample of the medical device.

(5) if any additional information, particulars or document, or sample of the medical device required under subsection (4) is not given by the applicant within the period specified in the request or any extension of time granted by the Authority, the application shall be deemed to be withdrawn and shall not be further proceeded with, but without affecting the right of the applicant to make a fresh application.

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