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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DRAFT GUIDANCE DOCUMENTS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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UKK
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INFOGRAPHIC
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pdf
surat pekeliling bil.2_2018 (bm)_Rev 2_Obsolete.pdf
( pdf, 1.43 MB )
(4492 downloads)
Popular
17 Mar 2023
pdf
surat pekeliling bil.2_2018 (Eng)_Rev 2_Obsolete.pdf
( pdf, 1.25 MB )
(4686 downloads)
Popular
17 Mar 2023
pdf
surat pekeliling bil.2_2022_(eng).pdf
( pdf, 1.24 MB )
(4455 downloads)
Popular
04 Dec 2023
pdf
Surat pekeliling bil22016 (semakan 2)
( pdf, 244 KB )
(533 downloads)
Popular
28 Jan 2026
pdf
Surat Pekeliling MDA Bil. 1 (2024) BM.pdf
( pdf, 4.33 MB )
(4984 downloads)
Popular
06 May 2024
pdf
Surat Pekeliling MDA Bil. 1 (2024) EN.pdf
( pdf, 4.04 MB )
(5590 downloads)
Popular
06 May 2024
pdf
Surat Pekliling PBPP Bil 2 2014 (BM) Revision 4
( pdf, 304 KB )
(3055 downloads)
Popular
25 Oct 2021
pdf
Surat Pekliling PBPP Bil 2 2014 (Eng) Revision 4
( pdf, 292 KB )
(6783 downloads)
Popular
25 Oct 2021
pdf
SYARAT_SYARAT LESEN DUAL LANGUAGE_271222.pdf
( pdf, 57 KB )
(2486 downloads)
Popular
22 Jan 2024
pdf
Table MDDCI 2025
( pdf, 425 KB )
(2513 downloads)
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21 Jul 2025
pdf
TABLE MDDCI 2025.pdf
( pdf, 311 KB )
(1019 downloads)
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10 Feb 2025
pdf
Table of Fees.pdf
( pdf, 64 KB )
(5244 downloads)
Popular
21 Feb 2024
pdf
TATACARA PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024. (Kemaskini 9 Oktober 2024).pdf
( pdf, 319 KB )
(3129 downloads)
Popular
14 Oct 2024
pdf
TECHNICAL COMMITTEE MEETING MEDICAL DEVICE CLINICAL EVALUATION 2026
( pdf, 190 KB )
(953 downloads)
Popular
24 Dec 2025
pdf
Teks Perutusan Khas YAB PM 10042020
( pdf, 482 KB )
(12966 downloads)
Popular
10 Apr 2020
pdf
Teks Perutusan YAB PM PENJANA 05062020
( pdf, 153 KB )
(4517 downloads)
Popular
09 Jun 2020
document
Template for list of Questions for Consultation with MDA
( docx, 26 KB )
(2808 downloads)
Popular
28 Apr 2022
document
Template for list of questions for consultation.docx
( docx, 103 KB )
(1278 downloads)
Popular
04 Apr 2023
document
TEMPLATE FOR LOA.docx
( docx, 41 KB )
(2785 downloads)
Popular
03 Mar 2025
pdf
The Training of Fundamental Understanding of Medical Devices & IVDs
( pdf, 4.28 MB )
(884 downloads)
Popular
15 Jan 2026
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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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