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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DRAFT GUIDANCE DOCUMENTS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
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Date
pdf
4a. User Manual MDR A Front End User.pdf
( pdf, 7.18 MB )
(1465 downloads)
Popular
13 Feb 2024
pdf
4b. User Manual MDR BCD Front End User.pdf
( pdf, 5.85 MB )
(4872 downloads)
Popular
13 Feb 2024
pdf
5 JKTPP Schedule Planner 2022
( pdf, 105 KB )
(2721 downloads)
Popular
25 May 2022
pdf
5a. GMD Risk Classification.pdf
( pdf, 253 KB )
(10740 downloads)
Popular
13 Feb 2024
document
5APPEN_1.DOC
( doc, 233 KB )
(2370 downloads)
Popular
23 Jan 2025
pdf
5b. IVD Risk Classification.pdf
( pdf, 177 KB )
(3682 downloads)
Popular
13 Feb 2024
pdf
6 Clinical Investigational Plan (CIP)
( pdf, 195 KB )
(3330 downloads)
Popular
25 May 2022
pdf
6a. Grouping GMD.pdf
( pdf, 236 KB )
(5022 downloads)
Popular
13 Feb 2024
pdf
6b. Grouping - IVD.pdf
( pdf, 177 KB )
(3294 downloads)
Popular
13 Feb 2024
pdf
7 Clinical Performance Study Protocol (CPSP)
( pdf, 123 KB )
(4681 downloads)
Popular
06 Jul 2022
pdf
7 Investigator's Brochure (IB)
( pdf, 109 KB )
(2673 downloads)
Popular
25 May 2022
pdf
7. Conformity Assessment for Medical Device.pdf
( pdf, 275 KB )
(3379 downloads)
Popular
13 Feb 2024
pdf
7. Conformity Assessment for Medical Device.pdf
( pdf, 274 KB )
(3547 downloads)
Popular
05 Nov 2024
pdf
7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf
( pdf, 36 KB )
(1417 downloads)
Popular
18 Oct 2024
pdf
8 Investigator's Brochure (IB)
( pdf, 174 KB )
(6525 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 )
(6637 downloads)
Popular
13 Feb 2024
pdf
9.Fee Structure MDR.pdf
( pdf, 253 KB )
(13654 downloads)
Popular
13 Feb 2024
pdf
AKAUNTAN GRED WA41.pdf
( pdf, 698 KB )
(1384 downloads)
Popular
26 Jun 2023
pdf
AKAUNTAN GRED WA41.pdf
( pdf, 695 KB )
(2598 downloads)
Popular
27 Jun 2023
pdf
ANNEX A.pdf
( pdf, 28 KB )
(7720 downloads)
Popular
21 Feb 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
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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