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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DRAFT GUIDANCE DOCUMENTS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
- KETERHUTANGAN KEWANGAN YANG SERIUS
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
Press Release
MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
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Customer Satisfaction Survey Report
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pdf
5a. GMD Risk Classification.pdf
( pdf, 253 KB )
(6890 downloads)
Popular
13 Feb 2024
document
5APPEN_1.DOC
( doc, 233 KB )
(641 downloads)
Popular
23 Jan 2025
pdf
5b. IVD Risk Classification.pdf
( pdf, 177 KB )
(2296 downloads)
Popular
13 Feb 2024
pdf
6 Clinical Investigational Plan (CIP)
( pdf, 195 KB )
(2783 downloads)
Popular
25 May 2022
pdf
6a. Grouping GMD.pdf
( pdf, 236 KB )
(3475 downloads)
Popular
13 Feb 2024
pdf
6b. Grouping - IVD.pdf
( pdf, 177 KB )
(2150 downloads)
Popular
13 Feb 2024
pdf
7 Clinical Performance Study Protocol (CPSP)
( pdf, 123 KB )
(4037 downloads)
Popular
06 Jul 2022
pdf
7 Investigator's Brochure (IB)
( pdf, 109 KB )
(2060 downloads)
Popular
25 May 2022
pdf
7. Conformity Assessment for Medical Device.pdf
( pdf, 275 KB )
(2965 downloads)
Popular
13 Feb 2024
pdf
7. Conformity Assessment for Medical Device.pdf
( pdf, 274 KB )
(1845 downloads)
Popular
05 Nov 2024
pdf
7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf
( pdf, 36 KB )
(634 downloads)
Popular
18 Oct 2024
pdf
8 Investigator's Brochure (IB)
( pdf, 174 KB )
(5462 downloads)
Popular
06 Jul 2022
pdf
8. Recognized foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of verification process.pdf
( pdf, 98 KB )
(4108 downloads)
Popular
13 Feb 2024
pdf
9.Fee Structure MDR.pdf
( pdf, 253 KB )
(8048 downloads)
Popular
13 Feb 2024
pdf
AKAUNTAN GRED WA41.pdf
( pdf, 698 KB )
(1198 downloads)
Popular
26 Jun 2023
pdf
AKAUNTAN GRED WA41.pdf
( pdf, 695 KB )
(2240 downloads)
Popular
27 Jun 2023
pdf
ANNEX A.pdf
( pdf, 28 KB )
(5784 downloads)
Popular
21 Feb 2024
pdf
ANNEX B.pdf
( pdf, 122 KB )
(5719 downloads)
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21 Feb 2024
pdf
ANNEX C.pdf
( pdf, 52 KB )
(5513 downloads)
Popular
21 Feb 2024
pdf
ANNOUCEMENT - ESTABLISHMENTS ARE ADVISED TO SUBMIT MEDICAL DEVICE RE-REGISTRATION APPLICATION IN THE MeDC@St2.0+ SYSTEM ONE YEAR PRIOR TO CERTIFICATE EXPIRY DATE.pdf
( pdf, 65 KB )
(1892 downloads)
Popular
17 May 2024
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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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