Talian Hotline Kami
+603 - 8230 0300
Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Carta Organisasi
Kod Etika dan Tatakelakuan
Lembaga Pengarah
Pengurusan Tertinggi MDA
Kepimpinan Malaysia
Mantan CEO MDA
Bahagian
Pejabat Ketua Eksekutif
Unit Integriti
Unit Audit Dalam
Bahagian Hubungan Antarabangsa dan Industri
Bahagian Kawalan Pra Pasaran
Bahagian Dasar dan Perancangan Strategik
Bahagian Pasca Pasaran
Bahagian Penguatkuasaan
Bahagian Khidmat Pengurusan
Bahagian Kewangan
bahagian Komunikasi Korporat
Bahagian Undang-undang
Bahagian Digital dan Teknologi Maklumat
Bahagian Keurusetiaan
Unit Transformasi Regulatori
Soalan Lazim
Pelaksanaan Polisi Satu Lesen Tunggal
Pendaftaran, Pelesenan & Penguatkuasaan
Pelabelan Peranti Perubatan
Penilaian Teknikal
Hubungi
Borang Aduan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Arahan Am
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
Pelan Strategik
Persembahan Slide
Infografik
Pelan Antirasuah Organisasi (OACP)
Buletin MDA
Siaran Akhbar
Liputan Media (Keratan Akhbar)
Laporan Tahunan
Tinjauan Kepuasan Pelanggan
Hasil Kajian Kepuasan Pelanggan
Laporan Kajian Kepuasan Pelanggan
Informasi Integriti
Akademi Latihan (COE)
Penceramah
Pendaftaran
Perlesenan
Badan Penilaian Pematuhan (CAB)
Latihan
Pendaftaran
Perlesenan
Badan Penilaian Pematuhan (CAB)
Jadual Latihan
Cari
fas fa-search
Laman Utama
Dokumen
CAB & Establishment
Loading...
Folder
CAB & Establishment
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DRAFT GUIDANCE DOCUMENTS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
Pelan Anti Rasuah
Buletin MDA
Contoh Kategori Docman
Press Release
MEDICAL DEVICE ADVERTISEMENT APPROVAL
Pekeliling MDA
Pekeliling Kerajaan
Customer Satisfaction Survey Report
Integrity Information
Training Academy (COE)
Search
Reset
Toggle
Tajuk
Tarikh
pdf
E3 AMENDMENTS.pdf
( pdf, 266 KB )
(4036 muat turun)
Popular
25 Mac 2024
pdf
E4 SURRENDER.pdf
( pdf, 177 KB )
(913 muat turun)
Popular
25 Mac 2024
pdf
E5 COO.pdf
( pdf, 247 KB )
(3910 muat turun)
Popular
25 Mac 2024
pdf
E6 WITHDRAWAL.pdf
( pdf, 189 KB )
(3052 muat turun)
Popular
25 Mac 2024
pdf
F. Explanatory on amendment major and minor.pdf
( pdf, 227 KB )
(4500 muat turun)
Popular
25 Mac 2024
pdf
G. Requirement on Good Distribution Practice of Medical Device (GDPMD).pdf
( pdf, 420 KB )
(4552 muat turun)
Popular
25 Mac 2024
pdf
GD Rev04
( pdf, 276 KB )
(4557 muat turun)
Popular
28 Sep 2017
pdf
GENUINE 15122016
( pdf, 262 KB )
(4928 muat turun)
Popular
27 Dis 2016
pdf
GENUINE DIAMOND SDN BHD (MDA CAB 016) 07032019
( pdf, 174 KB )
(3874 muat turun)
Popular
25 Apr 2019
pdf
I. License Statistic.pdf
( pdf, 197 KB )
(2507 muat turun)
Popular
25 Mac 2024
pdf
KGS CERTIFICATION SDN BHD (MDA CAB 013) 07032019
( pdf, 234 KB )
(4866 muat turun)
Popular
25 Apr 2019
pdf
KGS29052016
( pdf, 97 KB )
(4869 muat turun)
Popular
18 Mei 2016
pdf
KIWA (MDA CAB 021) 20190425
( pdf, 246 KB )
(2819 muat turun)
Popular
25 Apr 2019
pdf
KIWA (MDA CAB 021) 20190531X
( pdf, 246 KB )
(3396 muat turun)
Popular
31 Mei 2019
pdf
KIWA Rev02 11092019
( pdf, 248 KB )
(2998 muat turun)
Popular
17 Sep 2019
pdf
Lampiran 2 Syarat Syarat Pendaftaran Peranti Perubatan (1)
( pdf, 141 KB )
(8535 muat turun)
Popular
14 Apr 2021
pdf
List Of Active Establishment License
( pdf, 785 KB )
(8462 muat turun)
Popular
17 Jan 2020
pdf
List Of Active Establishment License 1 April 2020
( pdf, 532 KB )
(4072 muat turun)
Popular
02 Apr 2020
pdf
List Of Active Establishment License 1 July 2020
( pdf, 1022 KB )
(4540 muat turun)
Popular
01 Jul 2020
pdf
List Of Active Establishment License 12 Feb 2020
( pdf )
(119 muat turun)
Popular
12 Feb 2020
«
1
2
3
4
5
6
…
14
15
»
Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Carta Organisasi
Kod Etika dan Tatakelakuan
Lembaga Pengarah
Pengurusan Tertinggi MDA
Kepimpinan Malaysia
Mantan CEO MDA
Bahagian
Pejabat Ketua Eksekutif
Unit Integriti
Unit Audit Dalam
Bahagian Hubungan Antarabangsa dan Industri
Bahagian Kawalan Pra Pasaran
Bahagian Dasar dan Perancangan Strategik
Bahagian Pasca Pasaran
Bahagian Penguatkuasaan
Bahagian Khidmat Pengurusan
Bahagian Kewangan
bahagian Komunikasi Korporat
Bahagian Undang-undang
Bahagian Digital dan Teknologi Maklumat
Bahagian Keurusetiaan
Unit Transformasi Regulatori
Soalan Lazim
Pelaksanaan Polisi Satu Lesen Tunggal
Pendaftaran, Pelesenan & Penguatkuasaan
Pelabelan Peranti Perubatan
Penilaian Teknikal
Hubungi
Borang Aduan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Arahan Am
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
Pelan Strategik
Persembahan Slide
Infografik
Pelan Antirasuah Organisasi (OACP)
Buletin MDA
Siaran Akhbar
Liputan Media (Keratan Akhbar)
Laporan Tahunan
Tinjauan Kepuasan Pelanggan
Hasil Kajian Kepuasan Pelanggan
Laporan Kajian Kepuasan Pelanggan
Informasi Integriti
Akademi Latihan (COE)
Penceramah
Pendaftaran
Perlesenan
Badan Penilaian Pematuhan (CAB)
Latihan
Pendaftaran
Perlesenan
Badan Penilaian Pematuhan (CAB)
Jadual Latihan
×