欧盟医疗器械认证 Medical Device Act.pdf

Medical Device 1 laws OF MalaYsIa act 737 MedIcal devIce act 2012 2 Laws of Malaysia Act 737 Date of Royal Assent ... ... 30 January 2012 Date of publication in the Gazette ... ... ... 9 February 2012 Publisher’s copyright c Percetakan nasIOnal MalaYsIa berhad All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording and/or otherwise without the prior permission of Percetakan nasional Malaysia berhad (appointed Printer to the Government of Malaysia). Medical Device 3 laws OF MalaYsIa act 737 MedIcal devIce act 2012 ARRANGEMENT OF sEcTiONs Part i PRELiMiNARY section 1. short title and commencement 2. interpretation Part ii REGisTRATiON OF MEDicAL DEVicE AND cONFORMiTY AssEssMENT BODY chapter 1 Registration of medical device 3. classification of medical device 4. Manufacturer’s obligations 5. Requirement for registration of medical device 6. Application for registration of medical device 7. Registration and refusal to register medical device 8. Power to imp