(1) All medical device shall be: appropriately classified in accordance with the classification rules as specified in FIRST SCHEDULE; and appropriately grouped using the rules of grouping as specified in SECOND SCHEDULE. (2) In the event of any dispute between the establishment and a conformity assessment body over a classification of a medical device, the […]
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 […]
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 2, Designated medical device permit. 27. REQUIREMENT FOR DESIGNATED MEDICAL DEVICE PERMIT (1) No person shall use or operate any designated medical device unless the person holds a […]
