By that, the IVD test kit which is intended for professional use as claimed in the instruction for use (IFU) of the device is not allowed to be supplied or marketed to the public for civilian use. This information can be referred to as “Lampiran 2” (Attachment 2), point 1.14.

Based on Attachment 2, there are 14 general conditions for the registration. Other than that, the attachment explained any amendments to the information concerning the registered medical device shall be notified to MDA per the guidelines set by the authority. As well, any establishment that fails to comply with any medical device registration condition maybe cancels its medical device registration. For any canceled medical registration certificate, it was not allowed to be imported, exported, or placed in the Malaysian market. The establishment shall comply with Act 737, it is subsidiary regulations, and registration conditions.




The Announcement for IVD Test Kit for Professional Use

Medical Device Registration Conditions - Attachment 2