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Folder GUIDANCE DOCUMENTS

Documents

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pdf Guidance Document on Notification for Orphaned Medical Device ( pdf, 545 KB ) (2833 downloads) Popular
pdf Guidance Document on Notification of Export Only Medical Device ( pdf, 332 KB ) (3137 downloads) Popular
pdf Guidance Document Personal Protective Equipment (PPE) Requirements ( pdf, 376 KB ) (7881 downloads) Popular
pdf Guidance Document Placement of HIV Self-test kit in Malaysia Market First Edition.pdf ( pdf, 630 KB ) (6871 downloads) Popular
pdf Guidance Document Product Grouping Second Edition - ANIS SUHAILA BINTI ABDUL RAHMAN FUAD (MDA).pdf ( pdf, 516 KB ) (26717 downloads) Popular
pdf Guidance Document Requirement for Export Permit Final ( pdf, 765 KB ) (7059 downloads) Popular
pdf Guidance Document Special Access Notification General Requirements ( pdf, 765 KB ) (3690 downloads) Popular
pdf Guidance Document_Declaration of Conformity _3 feb 2016 ( pdf, 331 KB ) (18175 downloads) Popular
pdf Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products ( pdf, 1.03 MB ) (4763 downloads) Popular
pdf Guideline on How to Apply for Product Classification Application (GD of Product Classification 4th Ver 2025) ( pdf, 374 KB ) (2513 downloads) Popular
pdf HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 737) ( pdf, 1.12 MB ) (26809 downloads) Popular
pdf Import And or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education ( pdf, 460 KB ) (20926 downloads) Popular
pdf IMPORT ANDOR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING O ( pdf, 749 KB ) (5422 downloads) Popular
pdf In Vitro Diagnostic (IVD) Medical Device Classification System ( pdf, 410 KB ) (4590 downloads) Popular
pdf IVD Medical Device Classification System ( pdf, 382 KB ) (16947 downloads) Popular
pdf LICENSING FOR ESTABLISHMENT ( pdf, 548 KB ) (17968 downloads) Popular
pdf Licensing for Establishment ( pdf, 520 KB ) (3946 downloads) Popular
pdf Mandatory Problem Reporting ( pdf, 344 KB ) (8704 downloads) Popular
pdf Mandatory Problem Reporting 60 60 10 june2020 ( pdf, 322 KB ) (8405 downloads) Popular
pdf Mandatory Problem Reporting 60 60 10 june2020 (2) ( pdf, 326 KB ) (12617 downloads) Popular

Medical Device Authority (MDA),
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