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GUIDANCE DOCUMENTS
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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DRAFT GUIDANCE DOCUMENTS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
powerpoint_presentation
Forms
Events
Presentation Slide
- Seminar Bersama Industri, Marriott Hotel 18-20 April 2018
Annual Report
Product Classification
MDA Staff - Forms
Training Programme
FCA
UKK
Strategic Plan
INFOGRAPHIC
Pelan Anti Rasuah
Buletin MDA
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MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
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pdf
8 CSDT
( pdf, 617 KB )
(37089 downloads)
Popular
14 Apr 2018
pdf
8 CSDT
( pdf, 619 KB )
(52169 downloads)
Popular
29 Nov 2021
pdf
9 Classification Rules
( pdf, 2.00 MB )
(39964 downloads)
Popular
14 Apr 2018
pdf
9 Classification Rules
( pdf )
(6761 downloads)
Popular
29 Nov 2021
pdf
Advertisement for Medical Device Requirements
( pdf, 487 KB )
(16820 downloads)
Popular
06 Oct 2020
pdf
Announcement Labelling_Revised
( pdf, 5 KB )
(6567 downloads)
Popular
06 Feb 2018
pdf
Arahan Am Bil. 1 (2024) - Satu Lesen Establismen Bagi Setiap Peranan
( pdf, 1.26 MB )
(7159 downloads)
Popular
04 Apr 2024
pdf
BK-BDKS-054 Borang Ulasan Umum Pembangunan Garis Panduan v01
( pdf, 206 KB )
(3738 downloads)
Popular
26 May 2017
document
BORANG ULASAN UMUM PEMBANGUNAN DOKUMEN PANDUAN GD LICENSING FOR ESTABLISHMENTS
( docx, 29 KB )
(3598 downloads)
Popular
08 Jun 2022
pdf
Change Notification for Registered Medical Device
( pdf, 639 KB )
(5324 downloads)
Popular
19 Nov 2021
pdf
Change Notification Scope
( pdf, 750 KB )
(8073 downloads)
Popular
13 Oct 2017
pdf
Change Notification Scope_50.20_12Sept17_updated
( pdf, 750 KB )
(5182 downloads)
Popular
08 Dec 2017
pdf
Change of Ownership for Medical Device Registration
( pdf, 356 KB )
(3969 downloads)
Popular
19 Nov 2021
pdf
CHANGE OWNERSHIP FOR MD REGISTRATION
( pdf, 778 KB )
(8016 downloads)
Popular
18 Jan 2017
pdf
Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices Second Edition.pdf
( pdf, 420 KB )
(13601 downloads)
Popular
09 Mar 2023
pdf
Code Of Advertisement (COA)
( pdf, 356 KB )
(5683 downloads)
Popular
19 Nov 2021
pdf
Common Submission Dossier Template (CSDT)
( pdf, 399 KB )
(14680 downloads)
Popular
16 Nov 2021
pdf
Common Submission Dossier Template (CSDT) 1
( pdf, 379 KB )
(5425 downloads)
Popular
16 Nov 2021
pdf
Common Submission Dossier Template (CSDT) of In Vitro Diagnostic (IVD) Medical Device
( pdf, 383 KB )
(3968 downloads)
Popular
16 Nov 2021
pdf
Common Submission Dossier Template (CSDT) of IVD Medical Device
( pdf, 363 KB )
(21383 downloads)
Popular
24 Oct 2013
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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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