GUIDANCE DOCUMENTS - Medical Device Authority (MDA)

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	Draft Guidance document Conformity Assessment for medical device	Muat turun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

IVD Medical Device Classification System

Essential Principles of Safety and Performance for IVD Medical Devices

Conformity Assessment for IVD Medical Devices

Common Submission Dossier Template (CSDT) of IVD Medical Device

MDA/GD-05 October 2013 First Edition- GUIDANCE ON THE PRODUCT GROUPING

MDA/GD-01 March 2014 First Edition - DEFINITION OF MEDICAL DEVICE

MDA/GD-02 March 2014 First Edition - ESSENTIAL PRINCIPLES OF SAFETY & PERFORMANCE OF MEDICAL DEVICE

MDA/GD-03 March 2014 First Edition - COMMON SUBMISSION DOSSIER TEMPLATE

MDA/GD-04 March 2014 First Edition - THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES

[MDA/RR] MDARR No 1 First Revision November 15_6Nov15

GRPMD

Guidance Document_Declaration of Conformity _3 feb 2016

LICENSING FOR ESTABLISHMENT

CHANGE OWNERSHIP FOR MD REGISTRATION

BK-BDKS-054 Borang Ulasan Umum Pembangunan Garis Panduan v01

Draft Guidance document Conformity Assessment for medical device

Guidance Document Requirement for Export Permit Final

Guidance document Conformity Assessment for medical device

Change Notification Scope

Notification Demonstration

	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