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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DRAFT GUIDANCE DOCUMENTS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
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UKK
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document
CI 4. Notification For Export_Disposal of Devices Upon Completion _Termination of Clinical Investiga
( doc, 482 KB )
(2992 downloads)
Popular
01 Mar 2018
document
CI 5. Notification Investigational Device (IDE) Progress Report
( doc, 390 KB )
(6269 downloads)
Popular
01 Mar 2018
document
CI 6. Notification of Change On Clinical Trial For Medical Devices Use
( doc, 462 KB )
(3204 downloads)
Popular
01 Mar 2018
pdf
COMPETENCY REGULATORY PROGRAMME
( pdf, 101 KB )
(11711 downloads)
Popular
05 Apr 2017
pdf
COMPETENCY REGULATORY PROGRAMME
( pdf, 153 KB )
(3772 downloads)
Popular
14 Jul 2018
document
Custom Made MD
( docx, 214 KB )
(6373 downloads)
Popular
01 Mar 2018
document
Customer Complaint Form
( docx, 48 KB )
(4308 downloads)
Popular
30 Sep 2016
document
Demo 1. Demo application form
( docx, 178 KB )
(3681 downloads)
Popular
10 Mar 2018
pdf
DEMO LIST UPDATED ON 05 03 2019
( pdf, 738 KB )
(3389 downloads)
Popular
06 Mar 2019
document
DISPOSAL OF MEDICAL DEVICE FOR SPECIAL ACCESS
( docx, 98 KB )
(5361 downloads)
Popular
04 Dec 2020
document
Education Form
( docx, 178 KB )
(2626 downloads)
Popular
10 Mar 2018
document
Feedback Form Medical Gas System Requiremens for Registration
( docx, 51 KB )
(3618 downloads)
Popular
24 Apr 2020
pdf
FLOWCHART PRODUCT CLASSIFICATION
( pdf, 88 KB )
(7087 downloads)
Popular
30 Dec 2016
document
FORM 1 MPR FORM MDA WEBSITE & FORM 2 INVESTIGATION FORM MDA WEBSITE
( docx, 49 KB )
(4689 downloads)
Popular
17 Feb 2021
document
FORM 1 MPR FORM MDA WEBSITE 10 01 2022
( docx, 50 KB )
(6836 downloads)
Popular
10 Jan 2022
document
FORM 2 INVESTIGATION FORM MDA WEBSITE 10 01 2022
( docx, 45 KB )
(6150 downloads)
Popular
10 Jan 2022
pdf
Instructions to fill in Skill Assessment & Gap Analysis
( pdf, 486 KB )
(3548 downloads)
Popular
05 Apr 2017
pdf
Instructions to fill in skill assessment & gap analysis matrix
( pdf, 486 KB )
(2582 downloads)
Popular
27 Jan 2018
document
Investigational Device (IDE) Progress Report
( doc, 390 KB )
(3639 downloads)
Popular
28 Feb 2019
document
Jan 2018 Medical device(s) list
( docx, 22 KB )
(10804 downloads)
Popular
23 Dec 2018
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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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