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Toggle Tajuk Muat turun
IVD Medical Device Classification System Muat turun
Essential Principles of Safety and Performance for IVD Medical Devices Muat turun
Conformity Assessment for IVD Medical Devices Muat turun
Common Submission Dossier Template (CSDT) of IVD Medical Device Muat turun
MDA/GD-05 October 2013 First Edition- GUIDANCE ON THE PRODUCT GROUPING Muat turun
MDA/GD-01 March 2014 First Edition - DEFINITION OF MEDICAL DEVICE Muat turun
MDA/GD-02 March 2014 First Edition - ESSENTIAL PRINCIPLES OF SAFETY & PERFORMANCE OF MEDICAL DEVICE Muat turun
MDA/GD-03 March 2014 First Edition - COMMON SUBMISSION DOSSIER TEMPLATE Muat turun
MDA/GD-04 March 2014 First Edition - THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES Muat turun
[MDA/RR] MDARR No 1 First Revision November 15_6Nov15 Muat turun
GRPMD Muat turun
Guidance Document_Declaration of Conformity _3 feb 2016 Muat turun
LICENSING FOR ESTABLISHMENT Muat turun
CHANGE OWNERSHIP FOR MD REGISTRATION Muat turun
BK-BDKS-054 Borang Ulasan Umum Pembangunan Garis Panduan v01 Muat turun
Draft Guidance document Conformity Assessment for medical device Muat turun
Guidance Document Requirement for Export Permit Final Muat turun
Guidance document Conformity Assessment for medical device Muat turun
Change Notification Scope Muat turun
Notification Demonstration Muat turun
  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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Ministry of Health Malaysia
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