pathHome
Advertisement
Home

MDB PINDAH 3

 

 


  •  
 LAUNCHING OF NEW MDA PORTAL AND MDA FEEDBACK MANAGEMENT SYSTEM (MDA FEMES)new
  •  
 FIRST ANNOUNCEMENT: INTERNATIONAL MEDICAL DEVICE CONFERENCE (IMDC) DAN MALAYSIA MEDICAL DEVICE EXPO (MyMEDEX) 2019new
  •  
 GUIDANCE DOCUMENT : NOTIFICATION OF MEDICAL DEVICE FOR SPECIAL ACCESS (FIRST EDITION APRIL 2019) new
  •  
 GUIDELINE DOCUMENT : HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT 2012 (ACT 73) (THIRD EDITION) new
  •  
 SEWAAN BILIK SEMINAR & MESYUARAT DI PRIMA 9, CYBERJAYA new
  •  
 ANNOUNCEMENT RENEWAL OF ESTABLISHMENT LICENCE & CHANGE OF OWNERSHIP FOR MEDICAL DEVICES REGISTRATION new
  •  
 REGISTRATION CONSULTATION FOR MEDCAST 2.0   new
  •  

PENGGUNAAN HELPDESK BAGI ADUAN MASALAH TEKNIKAL SISTEM MEDCAST 2.0 new


  •  

PEMAKLUMAN PERTUKARAN ALAMAT LAMAN WEB, E-MEL & SISTEM MeDC@St PIHAK BERKUASA PERANTI PERUBATAN new


  •  
 SEARCH ENGINE FOR LICENSED ESTABLISHMENT ( NEW APPLICATION )( CLICK HERE ) AND REGISTERED MEDICAL DEVICES ( CLICK HERE )new
  •  
  LIST OF RENEW LICENSED ESTABLISHMENT ( CLICK HERE   )new
  •  
 VOLUNTARY LISTING OF TECHNICAL PERSONNEL, TRAINING BODY (MeDTComp) OR COMPETENCY CERTIFICATION BODY UNDER MEDICAL DEVICE ACT 737 new
  •  
 GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES, THIRD EDITION NOVEMBER 2018  new
  •  
 GUIDANCE DOCUMENT CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE, THIRD EDITION NOVEMBER 2018  new
  •  
 REQUIREMENTS FOR APPLICATION OF CERTIFICATE OF FREE SALE (CFS) FOR EXPORT ONLY MEDICAL DEVICES NOVEMBER 2018  
  •  
  LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 22/10/2018) 
  •  
 RECALL: VOLUNTARY RECALL OF CLEAR & SIMPLE DIGITAL PREGNANCY TEST  
  •  

 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 08/10/2018)  


  •  
 PELANTIKAN KETUA EKSEKUTIF PBPP YANG BARU 
  •  
 PENGUMUMAN BERKAITAN PERMOHONAN PENDAFTARAN PERANTI PERUBATAN DAN PERLESENAN ESTABLISMEN DI BAWAH AKTA PERANTI PERUBATAN 2012 (AKTA 737) YANG MASIH TERTANGGUH SETELAH TAMAT TEMPOH PERALIHAN 
  •  
 CIRCULAR LETTER NO.4 YEAR 2014(REVISION 1) : MEDICAL DEVICE FOR IMPORT/EXPORT FROM / TO COUNTRIES WITHOUT DIPLOMATIC TIES WITH MALAYSIA 
  •  
 CIRCULAR LETTER NO.2 YEAR 2016(REVISION 1) : MEDICAL DEVICE PROCUREMENT FOR HEALTHCARE INSTITUTION  
  •  
 CIRCULAR LETTER NO. 4 YEAR 2018 (REVISION 1) : EXEMPTION FROM REGISTRATION REQUIREMENT FOR EXPORT ONLY MEDICAL DEVICE  
  •  
 PENGUMUMAN BERKENAAN PENGGUNAAN LOGO DAN NAMA PIHAK BERKUASA PERANTI PERUBATAN 
  •  
 CIRCULAR LETTER NO.5 YEAR 2018 :- ADDITIONAL TRANSITION PERIOD FOR MEDICAL DEVICE LABBELING
  •  

 SUMMARY OF MEDICAL DEVICE-DRUG-COSMETIC INTERPHASE (MDDCI) PRODUCT CLASSIFICATION DECISION 
  •  
 RECALL : VOLUNTARY RECALL OF DUREX REAL FEEL BATCH  
  

Archive Announcement

 We are pleased to inform that MDA has decided on new policies to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737).

 Guidance Documents are prepared to assist in the governing statutes and regulations under the Medical Device Act 2012  (Act 737) interpretation of policies

 Guidelines are prepared to
assist industries and healthcare faciities during implementation of medical device regulatory
system.

Click Here 

Click Here 

Click Here

 
 
SEARCH...
NOTIFICATION EXEMPTION

New Exemption From Registration Of Medical Devices 

REMARK:

Timeline 14 working days in which to make an assessment of the completed submission.

TCMDCE CALENDAR

Technical Committee of Medical Device Clinical Evaluation (TCMDCE) Meeting Calendar 2019

DEMONSTRATION LOG
               
TENDER / QUOTATION

KEPUTUSAN TENDER : MDA/TB01/2017 

KEPUTUSAN SEBUT HARGA : MDA/SH/01/2018

VACANCIES
No Vacancies Available
ONLINE SERVICES

MeDC@St 2.0 is a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit. Apply Now!


MeDC@St is a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit. Apply Now!


APPLICATION FOR CERTIFICATE OF FREE SALE (CFS) / MANUFACTURING CERTIFICATE
MeDTComp is a web-based Online Application System for Voluntary Listing Of Technical Personnel, Training Body (MeDTComp) Or Competency Certification Body Under Medical Device Act 737 .
Apply Now!
CUSTOMER SATISFACTION

Customer Satisfaction Survey

Give us your comment / feedback on our service!.

Customer Complaint

Fill up Customer Complaint Form on our service!.


Integrity Report

Give Us Any Report About MDA Integrity Matters 

(c) 2008-2015 Medical Device Authority. http://www.mdb.gov.my     [Privacy Policy]     [Security Policy]

Best viewed using Internet Explorer 7 and Mozilla Firefox with 1024 x 768 screen resolution.

Portal
   
MSC Malaysia