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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DRAFT GUIDANCE DOCUMENTS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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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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- KETERHUTANGAN KEWANGAN YANG SERIUS
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Date
document
Serious Adverse Events (SAE)
( doc, 366 KB )
(6983 downloads)
Popular
28 Feb 2019
spreadsheet
Skill Assessment & Gap Analysis Matrix
( xlsx, 49 KB )
(2822 downloads)
Popular
26 Jan 2018
document
Special Access
( doc, 290 KB )
(8064 downloads)
Popular
01 Mar 2018
document
Special Access Notification Form 5.8.2016 WORD
( doc, 289 KB )
(4976 downloads)
Popular
05 Aug 2016
pdf
Special Access Notification Form PDF
( pdf, 360 KB )
(7068 downloads)
Popular
05 Aug 2016
pdf
Syarat-Syarat Pendaftaran Peranti Perubatan
( pdf, 143 KB )
(8198 downloads)
Popular
06 Jan 2016
document
TCMDCE Meeting Calendar 2019
( doc, 146 KB )
(2360 downloads)
Popular
28 Feb 2019
document
Template_Technical Personnel
( docx, 139 KB )
(4773 downloads)
Popular
05 Apr 2017
document
Template_Training Body
( docx, 22 KB )
(3882 downloads)
Popular
05 Apr 2017
pdf
TRAINING ON CAB REGISTRATION UNDER THE ACT 737 (23 JULY 2018)
( pdf, 363 KB )
(2670 downloads)
Popular
01 Jun 2018
pdf
TRAINING ON QMS & PMSS (24 JULY 2018)
( pdf, 365 KB )
(2685 downloads)
Popular
01 Jun 2018
pdf
TRAINING ON TECHNICAL DOCUMENTATION & VERIFICATION (25 & 26 JULY 2018)
( pdf, 366 KB )
(3015 downloads)
Popular
01 Jun 2018
pdf
[16 & 17 MARCH 2020] TRAINING FOR CAB TECHNICAL DOCUMENTATION & VERIFICATION
( pdf, 407 KB )
(2534 downloads)
Popular
06 Feb 2020
pdf
[18 MARCH 2020] TRAINING FOR CAB CAB REGISTRATION UNDER THE ACT 737
( pdf, 405 KB )
(2565 downloads)
Popular
06 Feb 2020
pdf
[19 & 20 APR 2021] TRAINING FOR CAB TECHNICAL DOCUMENTATION & VERIFICATION
( pdf, 321 KB )
(4077 downloads)
Popular
31 Mar 2021
pdf
[19 & 20 NOVEMBER 2019] TRAINING FOR CAB TECHNICAL DOCUMENTATION & VERIFICATION
( pdf, 386 KB )
(2360 downloads)
Popular
22 Oct 2019
pdf
[19 MARCH 2020] TRAINING FOR CAB QMS & PMSS
( pdf, 405 KB )
(2466 downloads)
Popular
06 Feb 2020
pdf
[21 APR 2021] TRAINING FOR CAB CAB REGISTRATION UNDER THE ACT 737
( pdf, 318 KB )
(4126 downloads)
Popular
23 Mar 2021
pdf
[21 NOVEMBER 2019] TRAINING FOR CAB CAB REGISTRATION UNDER THE ACT 737
( pdf, 384 KB )
(2719 downloads)
Popular
22 Oct 2019
pdf
[22 & 23 FEB 2021] TRAINING FOR CAB TECHNICAL DOCUMENTATION & VERIFICATION (1)
( pdf, 321 KB )
(3996 downloads)
Popular
06 Jan 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
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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