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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DRAFT GUIDANCE DOCUMENTS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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Forms
Events
Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
MDA Staff - Forms
Training Programme
FCA
UKK
Strategic Plan
INFOGRAPHIC
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
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pdf
(MDA Recall P0462 53037605 2025)
( pdf, 216 KB )
(1825 downloads)
Popular
06 Jan 2026
pdf
(MDA Recall P0465 23252092 2025)
( pdf, 424 KB )
(1813 downloads)
Popular
06 Jan 2026
pdf
(MDA Recall P0470 60985031 2025)
( pdf, 435 KB )
(2716 downloads)
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06 Jan 2026
pdf
(MDA Recall P0471 96490080 2025)
( pdf, 446 KB )
(2422 downloads)
Popular
06 Jan 2026
document
06 UPDATED APPLICATION FORM FOR EVALUATION INNOVATIVE MD
( docx, 67 KB )
(1035 downloads)
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09 Mar 2026
pdf
070409 Covedien UK shiley
( pdf, 675 KB )
(5683 downloads)
Popular
28 Aug 2019
pdf
070409Colleague Pump Ltr
( pdf, 403 KB )
(5711 downloads)
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28 Aug 2019
pdf
1- Fifth Edition Guideline for Medical Device- Drug and Drug-Medical Device Combination Product (Final).pdf
( pdf, 1.22 MB )
(9033 downloads)
Popular
28 Feb 2024
pdf
10 b iii Decision JKTP Year 2023 - List of medical device risk classification (1) - 15 Feb 2024.pdf
( pdf, 327 KB )
(7310 downloads)
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16 Feb 2024
pdf
10 b iii Decision JKTP Year 2023 - List of medical device risk classification.pdf
( pdf, 326 KB )
(2645 downloads)
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14 Feb 2024
pdf
10 b iv Decision JKTP Year 2023 - List of products (medical device or non-medical device).pdf
( pdf, 266 KB )
(7350 downloads)
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14 Feb 2024
pdf
10-1.pdf
( pdf, 544 KB )
(4544 downloads)
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27 Nov 2023
pdf
10. STATISTIK TAHUN 2023 UNIT KOMBINASI PRODUK.pdf
( pdf, 693 KB )
(3745 downloads)
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28 Feb 2024
pdf
10_10.pdf
( pdf, 173 KB )
(3840 downloads)
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27 Nov 2023
pdf
10_11.pdf
( pdf, 247 KB )
(4393 downloads)
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27 Nov 2023
pdf
10_12.pdf
( pdf, 880 KB )
(3890 downloads)
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27 Nov 2023
pdf
10_13.pdf
( pdf, 880 KB )
(3639 downloads)
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27 Nov 2023
pdf
10_14.pdf
( pdf, 1.07 MB )
(4262 downloads)
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27 Nov 2023
pdf
10_15.pdf
( pdf, 692 KB )
(4163 downloads)
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27 Nov 2023
pdf
10_19.pdf
( pdf, 378 KB )
(3853 downloads)
Popular
27 Nov 2023
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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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