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GUIDANCE DOCUMENTS
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MEDICAL DEVICE (EXEMPTION) ORDER 2016
Keputusan Tender/Sebut Harga
Frequently Asked Questions (FAQ)
MEDICAL DEVICE (EXEMPTION) ORDER 2015
DRAFT GUIDANCE DOCUMENTS
Seminar Bersama Industri Peranti Perubatan 2015
Seminar on Medical Device Competency
GLP
Prosedur dan Borang
- Borang
- Prosedur
Surat Pekeliling PBPP / MDA's Circular Letter
- Surat Pekeliling PBPP
- MDA's Circular Letter
ICT (for MDA's staff only)
Seminar on Implementation of Act 737
Training for Conformity Assessment Body (CAB)
Tawaran Tender/Sebut Harga
- Sebut Harga MDASH042018 Sistem Maklum Balas
- Sebut Harga MDASH052018 Portal
Image
Awareness Program on Medical Device for Healthcare
Career
MeDC@St
Guideline Documents
GUIDANCE DOCUMENTS
CAB & Establishment
Regulation
powerpoint_presentation
Forms
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Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
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FCA
UKK
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INFOGRAPHIC
Pelan Anti Rasuah
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pdf
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
( pdf, 335 KB )
(3320 downloads)
Popular
16 Nov 2021
pdf
Product Grouping
( pdf, 648 KB )
(3172 downloads)
Popular
16 Nov 2021
pdf
Product Grouping for In Vitro Diagnostic (IVD) Medical Devices
( pdf, 1.11 MB )
(4958 downloads)
Popular
19 Nov 2021
pdf
Product Grouping for In Vitro Diagnostic (IVD) Medical Devices
( pdf, 1.11 MB )
(2687 downloads)
Popular
19 Nov 2021
pdf
Requirements For Application of Certificate of Free Sale (CFS) For Export Only Medical Devices
( pdf, 459 KB )
(7720 downloads)
Popular
19 Nov 2021
pdf
Requirements for Export Permit
( pdf, 349 KB )
(4214 downloads)
Popular
19 Nov 2021
pdf
Requirements for Export Permit
( pdf, 349 KB )
(2254 downloads)
Popular
19 Nov 2021
pdf
Requirements for Labelling of Medical Devices
( pdf, 313 KB )
(10083 downloads)
Popular
19 Nov 2021
pdf
Requirements For Labelling Of Medical Devices (revise)
( pdf, 440 KB )
(16930 downloads)
Popular
05 Feb 2018
pdf
Rules of Classification for General Medical Devices
( pdf, 2.15 MB )
(9861 downloads)
Popular
16 Nov 2021
pdf
Special Access – Requirements for Ventilator During Emergency Situation
( pdf, 1005 KB )
(1466 downloads)
Popular
19 Nov 2021
pdf
The Essential Principles of Safety and Performance of Medical Devices
( pdf, 255 KB )
(9360 downloads)
Popular
16 Nov 2021
document
WEBSITE ANNOUNCEMENT GD PPE
( docx, 16 KB )
(1877 downloads)
Popular
27 May 2022
pdf
[MDA/RR] MDARR No 1 First Revision November 15_6Nov15
( pdf, 410 KB )
(32491 downloads)
Popular
09 Nov 2015
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Home
Introduction
Background
Vision, Mission & Core Value
Functions
Organisation Chart
Code of Ethics and Conduct
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
Division
Chief Executive's Office
Integrity Unit
Internal Audit Unit
International and Industry Relations Division
Pre-Market Control Division
Policy and Strategic Planning Division
Post Market Division
Enforcement Division
Management Services Division
Finance Division
Corporate Communication Division
Legal Division
Digital and Information Technology Division
Secretarial Division
Regulatory Transformation Unit
FAQ
Single License Policy Implementation
Registration, Licensing & Enforcement
Labelling of Medical Devices
Technical Evaluation
Contact Us
Customer Complaint Form
Staff Directory
Documents
Legislation
General Directions
Circular Letter
Guidance Document
Guideline
Standard
Strategic Plan
Slide Presentation
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Annual Report
Customer Satisfaction Survey
Customer Satisfaction Survey Result
Customer Satisfaction Survey Report
Integrity Information
Training Academy (COE)
Speakers
Registration
Licensing
Comformity Assessment Body (CAB)
Syllabus
Registration
Licensing
Comformity Assessment Body (CAB)
Training Schedule
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