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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DRAFT GUIDANCE DOCUMENTS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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- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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pdf
NOTIFICATION OF MEDICAL DEVICE FOR DEMONSTRATION PDF
( pdf, 358 KB )
(4538 downloads)
Popular
05 Aug 2016
document
NOTIFICATION OF MEDICAL DEVICE FOR DEMONSTRATION WORD
( docx, 179 KB )
(3848 downloads)
Popular
05 Aug 2016
document
NOTIFICATION OF UNREGISTERED MEDICAL DEVICES FOR SPECIAL ACCES ROUTE B FORM
( docx, 143 KB )
(6265 downloads)
Popular
04 Dec 2020
document
Notification Serious Adverse Events (SAE).doc
( doc, 366 KB )
(2874 downloads)
Popular
27 May 2017
pdf
Notification Serious Adverse Events (SAE).pdf
( pdf, 367 KB )
(2975 downloads)
Popular
27 May 2017
document
Notification To Import Medical Devices For Clinical Use And Research Suportive Use.doc
( doc, 482 KB )
(3330 downloads)
Popular
27 May 2017
pdf
Notification To Import Medical Devices For Clinical Use And Research Suportive Use.pdf
( pdf, 398 KB )
(4980 downloads)
Popular
27 May 2017
document
Notification to Import Or Supply Medical Devices For Clinical Investigational Use.doc
( doc, 931 KB )
(3434 downloads)
Popular
27 May 2017
pdf
Notification to Import Or Supply Medical Devices For Clinical Investigational Use.pdf
( pdf, 925 KB )
(4233 downloads)
Popular
27 May 2017
pdf
Product Classification Application Form
( pdf, 781 KB )
(15401 downloads)
Popular
30 Dec 2016
spreadsheet
product list for CFS and MC application
( xlsx, 10 KB )
(5458 downloads)
Popular
05 Oct 2015
document
REGISTRATION FORM BTP (20 21 April 2020)
( docx, 500 KB )
(2198 downloads)
Popular
06 Mar 2020
document
REGISTRATION FORM BTP (24 25 June 2020)
( docx, 499 KB )
(2420 downloads)
Popular
17 Jun 2020
document
REGISTRATION FORM BTP FEB 2020
( docx, 500 KB )
(2843 downloads)
Popular
08 Jan 2020
document
REGISTRATION FORM TRAINING MGS 26JUNE2020
( docx, 499 KB )
(2582 downloads)
Popular
22 Jun 2020
pdf
REGISTRATION FORM - TRAINING FOR CAB (24 OCTOBER 2016)
( pdf, 346 KB )
(3473 downloads)
Popular
13 Oct 2016
pdf
REGISTRATION FORM CCM BTP
( pdf, 355 KB )
(3631 downloads)
Popular
02 Oct 2019
document
REGISTRATION FORM TRAINING MGS 18SEPTEMBER2020
( docx, 499 KB )
(2192 downloads)
Popular
14 Sep 2020
pdf
REGISTRATION FORM_NEW VENUE
( pdf, 470 KB )
(2869 downloads)
Popular
06 Apr 2018
pdf
SEMINAR REGISTRATION FORM 2018
( pdf, 348 KB )
(2915 downloads)
Popular
24 Feb 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
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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