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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DRAFT GUIDANCE DOCUMENTS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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GUIDANCE DOCUMENTS
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- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
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Date
document
Jan 2018 Medical device(s) list (3)
( docx, 22 KB )
(13036 downloads)
Popular
29 May 2019
document
MDA CoRe REGISTRATION FORM
( docx, 507 KB )
(2862 downloads)
Popular
06 Aug 2019
pdf
MDA REGULATORY INFORMATION SUBSCRIPTIONv4_10Mac18
( pdf, 206 KB )
(5640 downloads)
Popular
17 Apr 2018
document
Medical device(s) list
( docx, 16 KB )
(4580 downloads)
Popular
06 Feb 2017
document
Medical device(s) list
( docx, 22 KB )
(3776 downloads)
Popular
20 Jan 2018
document
Medical device(s) list (6)
( docx, 15 KB )
(3756 downloads)
Popular
24 Mar 2017
document
Medical device(s) list Jun 2017.docx
( docx, 29 KB )
(3837 downloads)
Popular
20 Jun 2017
pdf
NOTIFICATION FOR CUSTOM MADE MEDICAL DEVICES PDF
( pdf, 459 KB )
(5603 downloads)
Popular
05 Aug 2016
document
NOTIFICATION FOR CUSTOM MADE MEDICAL DEVICES WORD
( docx, 213 KB )
(4183 downloads)
Popular
05 Aug 2016
document
Notification For Export Disposal of Devices Upon Completion Termination of Clinical Investigation Drug Study
( doc, 486 KB )
(3661 downloads)
Popular
28 Feb 2019
document
Notification For Export Disposal of Devices Upon Completion Termination of Clinical Investigation Drug Study
( doc, 486 KB )
(5433 downloads)
Popular
06 Mar 2019
document
Notification For Export_Disposal of Devices Upon Completion _Termination of Clinical Investigation _
( doc, 482 KB )
(3182 downloads)
Popular
27 May 2017
pdf
Notification For Export_Disposal of Devices Upon CompletionTermination of Clinical Investigation pdf
( pdf, 344 KB )
(3674 downloads)
Popular
27 May 2017
pdf
Notification Form Export Only version6 website
( pdf, 344 KB )
(3157 downloads)
Popular
16 Jul 2019
pdf
Notification Form Export Only version7
( pdf, 344 KB )
(6050 downloads)
Popular
25 Sep 2019
document
Notification Investigational Device (IDE) Progress Report.doc
( doc, 390 KB )
(3209 downloads)
Popular
27 May 2017
pdf
Notification Investigational Device (IDE) Progress Report.pdf
( pdf, 451 KB )
(3305 downloads)
Popular
27 May 2017
document
Notification of Change On Clinical Trial For Medical Devices Use.doc
( doc, 461 KB )
(3221 downloads)
Popular
27 May 2017
pdf
Notification of Change On Clinical Trial For Medical Devices Use.pdf
( pdf, 493 KB )
(3742 downloads)
Popular
27 May 2017
document
Notification of Export Only Medical Device Form (Annex B)
( docx, 69 KB )
(2570 downloads)
Popular
11 Mar 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
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)
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