portal.mda.gov.my
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Submission: On April 12 via manual from DE — Scanned from DE
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Our Hotline+603 - 8230 0300
* Home
* Introduction
* Background
* Vision, Mission & Core Value
* Objectives
* Contact Us
* Organisation Chart
* Code of Ethics and Conduct
* Division
* Chief Executive's Office
* Corporate Communication Unit
* Legal Unit
* Integrity Unit
* Pre-Market Division & Post-Market and Enforcement Division
* Policy, International Affairs and Industry Facilitation (DASAR)
* Management and Service Unit
* FAQ
* Registration, Licensing & Enforcement
* Labelling of Medical Devices
* Technical Evaluation
* Contact Us
* Customer Complaint Form
* Customer Satisfaction Survey
* Staff Directory
* Documents
* Legislation
* Circular Letter
* Guidance Document
* Guideline
* Standard
* Annual Report
* Strategic Plan
* Slide Presentation
* Infographic
* Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
* Buletin MDA
* Counter Appointment
* Public
* Complaints (FEMES)
* Medical Device Safety & Performance Complaint
* Information and Awareness
* Safety Information
* Advertisement Approval
* Industry
* Medical Device Registration
* General Medical Device
* In-Vitro Diaganostic Device
* Change Notification
* Combination Product
* Withdrawal or Cancellation
* Conditional Approval for Covid19 RTK (Self-Test)
* Registry
* Check Medical Device Status
* MeDCASt V1.0
* MeDCASt V2.0
* Conditional Approval
* Establishment Licence
* How to Apply for Establishment Licence
* How to Apply for Renewal of Establishment Licence
* How to Apply for Amendment of Establishment License
* How to Apply for Withdrawal Application
* How to Apply for Surrender of Establishment Licence
* How to Apply for Change of Ownership Application
* Establishment Licence Application Status
* FAQ
* List of User Manual and Guidance Document
* Conformity Assessment Body (CAB)
* Application
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* Status
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ANNOUNCEMENT
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UNSCHEDULED SYSTEM MAINTENANCE ON 10TH APRIL 2023
10 April 2023
PERANTI PERUBATAN TIDAK BERDAFTAR DALAM PASARAN
28 March 2023
WITHDRAWAL OF MEDICAL DEVICE REGISTRATION (NEW AND RE-REGISTER) AND CHANGE OF
NOTIFICATION APPLICAT…
23 March 2023
PENGGUGURAN PERMOHONAN PENDAFTARAN (BARU DAN SEMULA) DAN PINDAAN PERANTI
PERUBATAN
23 March 2023
SECOND EDITION GUIDANCE DOCUMENT MDA/GD/0061: CLASSIFICATION OF REHABILITATION,
PHYSIOTHERAPY AND …
09 March 2023
KENYATAAN MEDIA : PENGUMUMAN PERANTI PERUBATAN TIDAK BERDAFTAR GAUZE PACK WITH
X-RAY DETECTABLE LIN…
09 March 2023
FIRST EDITION GUIDANCE DOCUMENT MDA/GD/0064: NOTIFICATION OF CUSTOM-MADE MEDICAL
DEVICES
01 March 2023
PRESS RELEASE MEDICAL DEVICE AUTHORITY (MDA), MINISTRY OF HEALTH MALAYSIA MDA
INTRODUCES IT’S NE…
24 February 2023
KENYATAAN MEDIA PELAKSANAAN PEMBAYARAN MELALUI SISTEM BAYARNOW
24 February 2023
CAB PROFICIENCY TRAININGS FOR NEW / FRESH PERSONNEL SANCTIONED BY THE MEDICAL
DEVICE AUTHORITY ORGAN…
21 February 2023
All announcement
COVID-19 RECENT INFORMATION
PENGUMUMAN: PEMBATALAN KELULUSAN BERSYARAT (CONDITIONAL APPROVAL) KIT UJIAN
KENDIRI COVID-19
Hits:9796
REGISTRATION OF COVID-19 IVD TEST KITS
Hits:13075
Information list
INFOGRAPHIC
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HOW DO I KEEP UP WITH THE…
16-12-2022
SEMAK DAHULU BARU BELI
22-07-2022
MEDICAL DEVICE ONLINE PURCHASING
04-07-2022
PELIHARALAH HUBUNGAN SESAMA RAKAN SEKERJA
23-02-2022
ELAKKAN KONFLIK KEPENTINGAN
23-02-2022
PENGURUSAN DAN PENGUATKUASAAN WARNA KAD PERAKAM WAKTU…
23-02-2022
KETERHUTANGAN KEWANGAN YANG SERIUS ADALAH SUATU KESALAHAN…
24-01-2022
GANGGUAN SEKSUAL ADALAH SATU KESALAHAN
24-01-2022
STOP SEXUAL HARRASMENT
24-01-2022
4 KESALAHAN UTAMA RASUAH (AKTA SPRM 2009)…
24-01-2022
PERMOHONAN MELAKUKAN KERJA LUAR
24-01-2022
PEKERJAAN LUAR ATAU KERJA SAMBILAN
24-01-2022
KEWAJIPAN MEMATUHI PERATURAN
24-01-2022
ETIKA BEKERJA DARI RUMAH
24-01-2022
RASUAH
24-01-2022
PENGURUSAN DAN PENGUATKUASAAN WARNA KAD PERAKAM WAKTU…
24-01-2022
All infographic
SUSPENSION AND CANCELLATION OF ESTABLISHMENT LICENCE AND MEDICAL DEVICE
REGISTRATION
Semua establismen yang menjalankan aktiviti meletakkan peranti perubatan dalam
pasaran perlu mempunyai Lesen Establismen dan peranti perubatan tersebut perlu
didaftarkan seperti yang termaktub dalam Akta Peranti Perubatan 2012 (Akta 737).
Orang awam boleh menyemak status Lesen Establismen dan pendaftaran peranti
perubatan melalui carian akses di pautan https://mmdr.mda.gov.my/public/.
Walau bagaimanapun, terdapat establismen yang telah melanggar Akta 737 dan
Peraturan Peranti Perubatan 2012. Read more
NEWS
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KUNJUNGAN HORMAT PIHAK BERKUASA PERANTI PERUBATAN (MDA) KE ATAS PENGARAH
BAHAGIAN PERKHIDMATAN KEJURUTERAAN...
Putrajaya - Ketua Eksekutif Pihak Berkuasa Peranti Perubatan (MDA), YBrs....
Read more
MESYUARAT AHLI PEKERJA MDA
Cyberjaya – Mesyuarat Ahli Pekerja MDA telah diadakan di Bilik...
Read more
KUNJUNGAN CENTRE FOR INNOVATION IN MEDICAL ENGINEERING (CIME), UNIVERSITI MALAYA
TERHADAP KETUA EKSEKUTIF...
10 April 2023 - Pihak Berkuasa Peranti Perubatan (MDA) telah...
Read more
MEDICAL DEVICE AUTHORIY (MDA) JALIN HUBUNGAN KERJASAMA BERSAMA KEMENTERIAN
PERDAGANGAN DALAM NEGERI (KPDN)...
Putrajaya - Ketua Eksekutif Pihak Berkuasa Peranti Perubatan (MDA), YBrs....
Read more
SESI LIBAT URUS BERSAMA BAHAGIAN PEROLEHAN DAN PENSWASTAAN, KKM DAN EJEN
PENENDER PERANTI...
SESI LIBAT URUS BERSAMA BAHAGIAN PEROLEHAN DAN PENSWASTAAN, KKM DAN...
Read more
All news
SAFETY INFORMATION
The following documents are summary of some medical device safety information
related to potentially hazardous cases. It only serves as a quick reference and
in no way should be considered as exhaustive and up-to-date. Please refer to the
source of information and your product supplier for details.
For Listing of Recalls & Listing of Field Safety Notice, please Click Here!
E-SERVICES
SATISFACTION SURVEY
Your Satisfaction is Our Goal
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EVENTS
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1. Training
2. Job Vacancy
3. Acquisition
4. Government Links
5. Links
There are currently no acquisition announcement
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Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA
+603 - 8230 0300 +603 - 8230 0200 mdb [AT] mda [DOT] gov [DOT] my
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Today 2718 Yesterday 5644 Week 13046 Month 65117 Visitor Counter: 116825297
* Last Modified: 12 April 2023.
Copyright © 2023 Medical Device Authority
Ministry of Health Malaysia
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* Home
* Introduction
* Background
* Vision, Mission & Core Value
* Objectives
* Contact Us
* Organisation Chart
* Code of Ethics and Conduct
* Division
* Chief Executive's Office
* Corporate Communication Unit
* Legal Unit
* Integrity Unit
* Pre-Market Division & Post-Market and Enforcement Division
* Policy, International Affairs and Industry Facilitation (DASAR)
* Management and Service Unit
* FAQ
* Registration, Licensing & Enforcement
* Labelling of Medical Devices
* Technical Evaluation
* Contact Us
* Customer Complaint Form
* Customer Satisfaction Survey
* Staff Directory
* Documents
* Legislation
* Circular Letter
* Guidance Document
* Guideline
* Standard
* Annual Report
* Strategic Plan
* Slide Presentation
* Infographic
* Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
* Buletin MDA
* Counter Appointment
IMPORTANT NOTICE: Close
NOTICE OF MDA COUNTER SERVICE
Dear valued customers,
Our counter operation hours are as follows:
OPERATION HOUR
Monday to Thursday : 9.00 am to 1.00 pm > 1.30 pm to 4.30 pm
Friday : 9.00 am to 12.15 pm > 2.15 pm to 4.30 pm
Weekends & Public Holidays > Closed
If you have any inquiries, you may call us at 03-8230 0300 or forward your
inquiries to femes.mda.gov
Thank you.