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
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
Arahan AM
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
UKK
Loading...
Folder
UKK
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DRAFT GUIDANCE DOCUMENTS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
4a. User Manual MDR A Front End User.pdf
( pdf, 7.18 MB )
(1251 muat turun)
Popular
13 Feb 2024
pdf
4b. User Manual MDR BCD Front End User.pdf
( pdf, 5.85 MB )
(4193 muat turun)
Popular
13 Feb 2024
pdf
5 JKTPP Schedule Planner 2022
( pdf, 105 KB )
(2458 muat turun)
Popular
25 Mei 2022
pdf
5a. GMD Risk Classification.pdf
( pdf, 253 KB )
(9233 muat turun)
Popular
13 Feb 2024
dokumen
5APPEN_1.DOC
( doc, 233 KB )
(1254 muat turun)
Popular
23 Jan 2025
pdf
5b. IVD Risk Classification.pdf
( pdf, 177 KB )
(3003 muat turun)
Popular
13 Feb 2024
pdf
6 Clinical Investigational Plan (CIP)
( pdf, 195 KB )
(3027 muat turun)
Popular
25 Mei 2022
pdf
6a. Grouping GMD.pdf
( pdf, 236 KB )
(4282 muat turun)
Popular
13 Feb 2024
pdf
6b. Grouping - IVD.pdf
( pdf, 177 KB )
(2717 muat turun)
Popular
13 Feb 2024
pdf
7 Clinical Performance Study Protocol (CPSP)
( pdf, 123 KB )
(4341 muat turun)
Popular
06 Jul 2022
pdf
7 Investigator's Brochure (IB)
( pdf, 109 KB )
(2360 muat turun)
Popular
25 Mei 2022
pdf
7. Conformity Assessment for Medical Device.pdf
( pdf, 275 KB )
(3185 muat turun)
Popular
13 Feb 2024
pdf
7. Conformity Assessment for Medical Device.pdf
( pdf, 274 KB )
(2832 muat turun)
Popular
05 Nov 2024
pdf
7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf
( pdf, 36 KB )
(1023 muat turun)
Popular
18 Okt 2024
pdf
8 Investigator's Brochure (IB)
( pdf, 174 KB )
(6037 muat turun)
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 )
(5576 muat turun)
Popular
13 Feb 2024
pdf
9.Fee Structure MDR.pdf
( pdf, 253 KB )
(11413 muat turun)
Popular
13 Feb 2024
pdf
AKAUNTAN GRED WA41.pdf
( pdf, 698 KB )
(1269 muat turun)
Popular
26 Jun 2023
pdf
AKAUNTAN GRED WA41.pdf
( pdf, 695 KB )
(2414 muat turun)
Popular
27 Jun 2023
pdf
ANNEX A.pdf
( pdf, 28 KB )
(6802 muat turun)
Popular
21 Feb 2024
«
1
2
3
4
5
…
19
20
»
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
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
Arahan AM
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
×