Medical Device Registration In Malaysia

Murni Ahmad

Involved In Discussions
Laws & Regulation for reference

  1. Medical Device Act 737
  2. Medical Device Regulation 2012 Fist Revision Nov 15
 

Attachments

  • 5 MEDICAL DEVICE ACT (Act 737).pdf
    470.9 KB · Views: 46
  • MEDICAL DEVICE REGULATIONS 2012 First Revision November 15_6Nov15 (1).pdf
    410.7 KB · Views: 52

Murni Ahmad

Involved In Discussions
Main guidance for Malaysia Medical Device Registration
  1. GD03 CSDT - similar to technical file
  2. GD 41 Change Ownership- transfer or change of product registration holder
  3. GD 20 Change Notification - amendment to an existing product registration
 

Attachments

  • MDA.GD-03 _CSDT 1403.pdf
    442.9 KB · Views: 27
  • 41 CHANGE OWNERSHIP FOR MD REGISTRATION.pdf
    784.7 KB · Views: 47
  • MDAGD0020 Change Notification 3rd Ed November 2018.pdf
    514.1 KB · Views: 74

Murni Ahmad

Involved In Discussions
Establishment license, a requirement to become the product registration holder in Malaysia
 

Attachments

  • MDARR No 1 November 2015.pdf
    406.8 KB · Views: 38
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