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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DRAFT GUIDANCE DOCUMENTS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
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MeDC@St
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GUIDANCE DOCUMENTS
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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document
Fca1
( doc, 324 KB )
(4240 downloads)
Popular
05 Sep 2019
pdf
Fca2
( pdf, 688 KB )
(4272 downloads)
Popular
05 Sep 2019
pdf
Fca3
( pdf, 39 KB )
(4226 downloads)
Popular
05 Sep 2019
document
Fca4
( doc, 39 KB )
(4070 downloads)
Popular
05 Sep 2019
pdf
FCAMdtronic ICD CRT May2010
( pdf, 421 KB )
(3432 downloads)
Popular
04 Sep 2019
pdf
Feb09 Baxter Notification
( pdf )
(4258 downloads)
Popular
04 Sep 2019
pdf
Field Safety Notice (MDA_FCA_P1276_30030441_2025) (sYep1JSS).pdf
( pdf, 168 KB )
(2424 downloads)
Popular
05 May 2025
pdf
FMI 34142 Customer Letter (MDA_FCA_P1251_86707162_2025) (bVeQ9MK0).pdf
( pdf, 347 KB )
(1309 downloads)
Popular
05 May 2025
pdf
FMI 34142 Customer Letter (MDA_FCA_P1252_92049677_2025) (uWwP1EOb).pdf
( pdf, 347 KB )
(1619 downloads)
Popular
05 May 2025
pdf
FMI 38016_FSN (MDA_FCA_P1279_20157066_2025) (x7otOIrA).pdf
( pdf, 371 KB )
(2242 downloads)
Popular
05 May 2025
pdf
FMI 38016_FSN (MDA_FCA_P1280_75147006_2025) (7VpVllru).pdf
( pdf, 371 KB )
(2141 downloads)
Popular
05 May 2025
pdf
FMI 38017_FSN (MDA_FCA_P1281_19211452_2025) (EQiftP2X).pdf
( pdf, 333 KB )
(2209 downloads)
Popular
05 May 2025
pdf
FMI 38017_FSN (MDA_FCA_P1282_91662220_2025) (ehqcrCoP).pdf
( pdf, 333 KB )
(2272 downloads)
Popular
05 May 2025
document
Fnp1
( doc, 757 KB )
(3892 downloads)
Popular
05 Sep 2019
document
Fnp2
( doc, 555 KB )
(3496 downloads)
Popular
05 Sep 2019
pdf
Fnp3
( pdf, 569 KB )
(5222 downloads)
Popular
05 Sep 2019
pdf
FSN 03 2025 57xxx EN (MDA FCA P1314 36051957 2025) (SnBWMlXF)
( pdf, 3.02 MB )
(2344 downloads)
Popular
26 Jun 2025
pdf
FSN FA-25031 Malaysia (MDA_FCA_P1263_61210361_2025) (wEVxEIHY).pdf
( pdf, 339 KB )
(2227 downloads)
Popular
05 May 2025
pdf
FSN IM00888 MAGLIFE RT1 fr EN (MDA FCA P1291 92989711 2025) (Kl5DJoU3)
( pdf, 186 KB )
(2173 downloads)
Popular
03 Jun 2025
pdf
FSN P074
( pdf, 470 KB )
(6444 downloads)
Popular
20 Sep 2021
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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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