Talian Hotline Kami
+603 - 8230 0300
Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Carta Organisasi
Kod Etika dan Tatakelakuan
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
Bahagian
Pejabat Ketua Eksekutif
Unit Komunikasi Korporat
Unit Undang-undang
Unit Integriti
Secretarial Unit
Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
Soalan Lazim
Single License Policy Implementation
Pendaftaran, Pelesenan & Penguatkuasaan
Labelling of Medical Devices
Technical Evaluation
Hubungi
Borang Aduan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
General Directions
Strategic Plan
Persembahan Slide
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Laporan Tahunan
Customer Satisfaction Survey
Customer Satisfaction Survey Result
Laporan Kajian Kepuasan Pelanggan
Cari
fas fa-search
Laman Utama
Dokumen
FCA
Loading...
Folder
FCA
Dokumen
Search for documents
Find by title or description…
Kategori
recall
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DRAFT GUIDANCE DOCUMENTS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
Pekeliling Kerajaan
Customer Satisfaction Survey Report
Search
Reset
Toggle
Tajuk
Tarikh
pdf
FA-2025-009 Customer Letter Malaysia and Reply form (MDA_FCA_P1284_82158291_2025) (iKGftQfh).pdf
( pdf, 105 KB )
(279 muat turun)
Popular
05 Mei 2025
pdf
FA-2025-009 Customer Letter Malaysia and Reply form (MDA_FCA_P1285_19643153_2025) (8gW7neNJ).pdf
( pdf, 105 KB )
(270 muat turun)
Popular
05 Mei 2025
pdf
FA-24068 FSN (MDA_FCA_P1134_18429856_2025) (bvfy8joE) (1).pdf
( pdf, 504 KB )
(670 muat turun)
Popular
05 Feb 2025
pdf
FA-AM-JAN2025-302B_Malaysia (MDA_FCA_P1138_58042219_2025) (tVV6dwhy).pdf
( pdf, 314 KB )
(660 muat turun)
Popular
05 Feb 2025
pdf
FA1265_HVAD_Battery_Performance_Update_-_regional_patient_letter_template.pdf
( pdf, 325 KB )
(1613 muat turun)
Popular
07 Apr 2023
pdf
FA1455_Controller_2.0_Disable-VAD-Stopped-Alarm_-_regional_plan (MDA_FCA_P1136_75285346_2025) (Dh05qk9V).pdf
( pdf, 715 KB )
(648 muat turun)
Popular
05 Feb 2025
pdf
FA1469 Potential Erroneous Electrical Reset Message consignee letter and conf form (WITH SmartSync (MDA FCA P1327 14153342 2025) (5SuinyTo)
( pdf, 551 KB )
(144 muat turun)
Popular
26 Jun 2025
pdf
FA1475 Update to Align Abort Button consignee letter and conf form (WITH SmartSync update) (MDA FCA P1328 36402143 2025) (mRJv8Y2U)
( pdf, 560 KB )
(148 muat turun)
Popular
26 Jun 2025
pdf
FA1489 Nellcor SpO2 Patient Monitor Safety Notice consignee letter and confirmation form (MDA FCA P1330 92315695 2025) (lIZP2NcZ)
( pdf, 547 KB )
(152 muat turun)
Popular
26 Jun 2025
pdf
FAV 2025 001 Customer letter Malaysia Final (MDA FCA P1296 71559190 2025) (r4E6XCH0)
( pdf, 120 KB )
(191 muat turun)
Popular
03 Jun 2025
dokumen
FCA June
( docx, 16 KB )
(50 muat turun)
26 Jun 2025
dokumen
Fca1
( doc, 324 KB )
(3052 muat turun)
Popular
05 Sep 2019
pdf
Fca2
( pdf, 688 KB )
(3081 muat turun)
Popular
05 Sep 2019
pdf
Fca3
( pdf, 39 KB )
(2852 muat turun)
Popular
05 Sep 2019
dokumen
Fca4
( doc, 39 KB )
(2985 muat turun)
Popular
05 Sep 2019
pdf
FCAMdtronic ICD CRT May2010
( pdf, 421 KB )
(2546 muat turun)
Popular
04 Sep 2019
pdf
Feb09 Baxter Notification
( pdf )
(2961 muat turun)
Popular
04 Sep 2019
pdf
Field Safety Notice (MDA_FCA_P1276_30030441_2025) (sYep1JSS).pdf
( pdf, 168 KB )
(286 muat turun)
Popular
05 Mei 2025
pdf
FMI 34142 Customer Letter (MDA_FCA_P1251_86707162_2025) (bVeQ9MK0).pdf
( pdf, 347 KB )
(173 muat turun)
Popular
05 Mei 2025
pdf
FMI 34142 Customer Letter (MDA_FCA_P1252_92049677_2025) (uWwP1EOb).pdf
( pdf, 347 KB )
(214 muat turun)
Popular
05 Mei 2025
«
1
2
…
23
24
25
26
27
…
34
35
»
Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Carta Organisasi
Kod Etika dan Tatakelakuan
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
Bahagian
Pejabat Ketua Eksekutif
Unit Komunikasi Korporat
Unit Undang-undang
Unit Integriti
Secretarial Unit
Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
Soalan Lazim
Single License Policy Implementation
Pendaftaran, Pelesenan & Penguatkuasaan
Labelling of Medical Devices
Technical Evaluation
Hubungi
Borang Aduan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
General Directions
Strategic Plan
Persembahan Slide
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Laporan Tahunan
Customer Satisfaction Survey
Customer Satisfaction Survey Result
Laporan Kajian Kepuasan Pelanggan
×