M Murni Ahmad Involved In Discussions Dec 14, 2020 #1 Dec 14, 2020 #1 Laws & Regulation for reference Medical Device Act 737 Medical Device Regulation 2012 Fist Revision Nov 15 Attachments 5 MEDICAL DEVICE ACT (Act 737).pdf 470.9 KB Views: 20 MEDICAL DEVICE REGULATIONS 2012 First Revision November 15_6Nov15 (1).pdf 410.7 KB Views: 22
Laws & Regulation for reference Medical Device Act 737 Medical Device Regulation 2012 Fist Revision Nov 15
M Murni Ahmad Involved In Discussions Dec 14, 2020 #2 Dec 14, 2020 #2 Main guidance for Malaysia Medical Device Registration GD03 CSDT - similar to technical file GD 41 Change Ownership- transfer or change of product registration holder GD 20 Change Notification - amendment to an existing product registration Attachments MDA.GD-03 _CSDT 1403.pdf 442.9 KB Views: 10 41 CHANGE OWNERSHIP FOR MD REGISTRATION.pdf 784.7 KB Views: 13 MDAGD0020 Change Notification 3rd Ed November 2018.pdf 514.1 KB Views: 14
Main guidance for Malaysia Medical Device Registration GD03 CSDT - similar to technical file GD 41 Change Ownership- transfer or change of product registration holder GD 20 Change Notification - amendment to an existing product registration
M Murni Ahmad Involved In Discussions Dec 14, 2020 #3 Dec 14, 2020 #3 Establishment license, a requirement to become the product registration holder in Malaysia Attachments MDARR No 1 November 2015.pdf 406.8 KB Views: 13