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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DRAFT GUIDANCE DOCUMENTS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
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Awareness Program on Medical Device for Healthcare
Career
MeDC@St
Guideline Documents
GUIDANCE DOCUMENTS
CAB & Establishment
Regulation
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
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UKK
Strategic Plan
INFOGRAPHIC
Pelan Anti Rasuah
Buletin MDA
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
1124877 OUS FSN Rev 3_SEA - signed (MDA_FCA_P1182_91407651_2025) (20EuKr2l).pdf
( pdf, 128 KB )
(1665 downloads)
Popular
03 Mar 2025
pdf
12_1.pdf
( pdf, 482 KB )
(2463 downloads)
Popular
10 Jan 2024
pdf
12_10.pdf
( pdf, 169 KB )
(2257 downloads)
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10 Jan 2024
pdf
12_2.pdf
( pdf, 508 KB )
(2812 downloads)
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10 Jan 2024
pdf
12_3.pdf
( pdf, 785 KB )
(2553 downloads)
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10 Jan 2024
pdf
12_4.pdf
( pdf, 753 KB )
(978 downloads)
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10 Jan 2024
pdf
12_5.pdf
( pdf, 469 KB )
(2408 downloads)
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10 Jan 2024
pdf
12_6.pdf
( pdf, 367 KB )
(2477 downloads)
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10 Jan 2024
pdf
12_7.pdf
( pdf, 908 KB )
(2782 downloads)
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10 Jan 2024
pdf
12_8.pdf
( pdf, 1.38 MB )
(2497 downloads)
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10 Jan 2024
pdf
12_9.pdf
( pdf, 169 KB )
(2546 downloads)
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10 Jan 2024
pdf
2. Overview of Combination Product Registration Framework.pdf
( pdf, 165 KB )
(3521 downloads)
Popular
28 Feb 2024
document
20080910 01 R MdtronicVLV
( doc, 321 KB )
(4147 downloads)
Popular
28 Aug 2019
pdf
20081024 01 R HotSoftPack
( pdf, 1.06 MB )
(5330 downloads)
Popular
28 Aug 2019
document
20090406 01 R Baxter Colleague
( doc, 322 KB )
(4004 downloads)
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28 Aug 2019
document
20090408 02 R WelchAllyn
( doc, 321 KB )
(4496 downloads)
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28 Aug 2019
document
20090408 03 R Covidien Tyco
( doc, 323 KB )
(4830 downloads)
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28 Aug 2019
document
20090630 05 R BBraunCelsite
( doc, 323 KB )
(4588 downloads)
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28 Aug 2019
pdf
20100128 01 R Mdtrnc
( pdf, 167 KB )
(4559 downloads)
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28 Aug 2019
document
20100204 01 R EXELINT
( doc, 319 KB )
(4430 downloads)
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28 Aug 2019
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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
Circular Letter
Guidance Document
Guideline
Standard
General Directions
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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