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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DRAFT GUIDANCE DOCUMENTS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
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Forms
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Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
MDA Staff - Forms
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FCA
UKK
Strategic Plan
INFOGRAPHIC
- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
(MD, NOT MD).pdf
( pdf, 143 KB )
(1154 downloads)
Popular
12 Jan 2025
pdf
0 1 PDF BORANG PERMOHONAN JAWATAN KOSONG BK UKP 012 VER 1
( pdf, 115 KB )
(4549 downloads)
Popular
05 Oct 2022
pdf
1 CRU Flow Chart Process
( pdf, 96 KB )
(5982 downloads)
Popular
25 May 2022
pdf
1 Device Study Flow Chart Process
( pdf, 432 KB )
(5882 downloads)
Popular
25 May 2022
pdf
1- Fifth Edition Guideline for Medical Device- Drug and Drug-Medical Device Combination Product (Final) 21012025.pdf
( pdf, 1.06 MB )
(1392 downloads)
Popular
23 Jan 2025
pdf
1- Fifth Edition Guideline for Medical Device- Drug and Drug-Medical Device Combination Product 17102024.pdf
( pdf, 1.06 MB )
(4105 downloads)
Popular
18 Oct 2024
pdf
1. IKLAN SH_07_2024 - SEBUT HARGA PERKHIDMATAN PENGURUS ACARA.pdf
( pdf, 22 KB )
(437 downloads)
Popular
30 Jul 2024
pdf
10(a) STATISTIK TAHUN 2023 UNIT KOMBINASI PRODUK.pdf
( pdf, 693 KB )
(634 downloads)
Popular
23 Jan 2025
pdf
10(b) STATISTIK TAHUN 2024 UNIT KOMBINASI PRODUK.pdf
( pdf, 727 KB )
(671 downloads)
Popular
23 Jan 2025
pdf
10. Implementation requirement on quality management system (QMS) and traceability form.pdf
( pdf, 328 KB )
(3315 downloads)
Popular
13 Feb 2024
pdf
10. Possible ways to register IVD analyzer.pdf
( pdf, 3.87 MB )
(2167 downloads)
Popular
13 Feb 2024
pdf
10a. Mesyuarat Jawatankuasa Teknikal Pengkelasan dan Pendaftaran, JKTPP 2024 Schedule Planner.pdf
( pdf, 161 KB )
(1761 downloads)
Popular
13 Feb 2024
pdf
11. MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device.pdf
( pdf, 147 KB )
(2484 downloads)
Popular
13 Feb 2024
pdf
11. MEDICAL DEVICE RE-REGISTRATION APPLICATION - IMPLEMENTATION OF INITIAL MDA RESPONSE WITHIN 14 WORKING DAYS.pdf
( pdf, 31 KB )
(659 downloads)
Popular
13 Feb 2024
pdf
11. PENGUMUMAN TEMPOH PERALIHAN PELAKSANAAN PENGGUNAAN SIJIL PENDAFTARAN PERANTI PERUBATAN ELEKTRONIK v1.pdf
( pdf, 10 KB )
(1677 downloads)
Popular
13 Feb 2024
pdf
12(a) ENDORSED 2023.pdf
( pdf, 195 KB )
(847 downloads)
Popular
23 Jan 2025
pdf
12(b) ENDORSED 2024.pdf
( pdf, 122 KB )
(935 downloads)
Popular
23 Jan 2025
pdf
12a. How to check whether a device is registered or not.pdf
( pdf, 286 KB )
(5313 downloads)
Popular
13 Feb 2024
pdf
13. Ringkasan Statistik Tahun 2023.pdf
( pdf, 87 KB )
(2658 downloads)
Popular
13 Feb 2024
pdf
2 ESubmission New Notification (final)
( pdf, 196 KB )
(2352 downloads)
Popular
06 Jul 2022
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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
Corporate Communication Unit
Legal Unit
Integrity Unit
Secretarial Unit
Pre-Market Control Division
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Management and Service 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
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