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MDB PINDAH 3

 

 


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SEARCH ENGINE FOR LICENSED ESTABLISHMENT ( NEW APPLICATION )( CLICK HERE ) AND REGISTERED MEDICAL DEVICES ( CLICK HERE )new
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  LIST OF RENEW LICENSED ESTABLISHMENT ( CLICK HERE   )new
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 VOLUNTARY LISTING OF TECHNICAL PERSONNEL, TRAINING BODY (MeDTComp) OR COMPETENCY CERTIFICATION BODY UNDER MEDICAL DEVICE ACT 737 new
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 GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES, THIRD EDITION NOVEMBER 2018  new
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 GUIDANCE DOCUMENT CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICE, THIRD EDITION NOVEMBER 2018  new
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 REQUIREMENTS FOR APPLICATION OF CERTIFICATE OF FREE SALE (CFS) FOR EXPORT ONLY MEDICAL DEVICES NOVEMBER 2018  
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  LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 22/10/2018) 
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 RECALL: VOLUNTARY RECALL OF CLEAR & SIMPLE DIGITAL PREGNANCY TEST  
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 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 08/10/2018)  


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 TRAININGS SANCTIONED BY THE AUTHORITY ON STATUTORY REQUIREMENTS (PROFICIENCY TRAININGS) NOVEMBER 2018   
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 PELANTIKAN KETUA EKSEKUTIF PBPP YANG BARU 
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 PENGUMUMAN BERKAITAN PERMOHONAN PENDAFTARAN PERANTI PERUBATAN DAN PERLESENAN ESTABLISMEN DI BAWAH AKTA PERANTI PERUBATAN 2012 (AKTA 737) YANG MASIH TERTANGGUH SETELAH TAMAT TEMPOH PERALIHAN 
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 CIRCULAR LETTER NO.4 YEAR 2014(REVISION 1) : MEDICAL DEVICE FOR IMPORT/EXPORT FROM / TO COUNTRIES WITHOUT DIPLOMATIC TIES WITH MALAYSIA 
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 CIRCULAR LETTER NO.2 YEAR 2016(REVISION 1) : MEDICAL DEVICE PROCUREMENT FOR HEALTHCARE INSTITUTION  
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 CIRCULAR LETTER NO. 4 YEAR 2018 (REVISION 1) : EXEMPTION FROM REGISTRATION REQUIREMENT FOR EXPORT ONLY MEDICAL DEVICE  
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 PENGUMUMAN BERKENAAN PENGGUNAAN LOGO DAN NAMA PIHAK BERKUASA PERANTI PERUBATAN 
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 CIRCULAR LETTER NO.5 YEAR 2018 :- ADDITIONAL TRANSITION PERIOD FOR MEDICAL DEVICE LABBELING
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 SUMMARY OF MEDICAL DEVICE-DRUG-COSMETIC INTERPHASE (MDDCI) PRODUCT CLASSIFICATION DECISION 
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 RECALL : VOLUNTARY RECALL OF DUREX REAL FEEL BATCH  
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 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 30/07/2018) 
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 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 24/07/2018) 
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 LIST FOR RENEWAL OF THE ESTABLISHMENT LICENCE CERTIFICATE READY FOR COLLECTION (UPDATED ON 18/07/2018)  
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 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 16/07/2018) 
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  LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 03/07/2018) 
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 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION (UPDATED ON 02/07/2018) 
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NOTA PERINGATAN PENGUATKUASAAN SEPENUHNYA KEPERLUAN PENDAFTARAN PERANTI PERUBATAN DI BAWAH SEKSYEN 5 AKTA PERANTI PERUBATAN 2012 (AKTA 737)

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 NOTIFICATION ON COMPETENCY OF BIOMEDICAL TECHNICAL PERSONNEL ACCORDING TO THE MEDICAL DEVICE ACT 2012 (ACT 737)
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 CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY NO. 2 YEAR 2018
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 CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY NO. 3 YEAR 2018
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 LICENSE CONDITION FIRST REVISION 
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 MEDICAL DEVICE AUTHORITY (MDA) REGULATORY INFORMATION SUBSCRIPTION  
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 CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY NO. 3 YEAR 2017 (REVISION 1)
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IMPORT AND/OR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING OR EDUCATION

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 LIST OF MEDICAL DEVICE REGISTRATION CERTIFICATES READY FOR COLLECTION

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GUIDANCE DOCUMENT ON REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES, SECOND EDITION JANUARY 2018

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APPLICATION FOR ADDITIONAL TECHNICAL PERSONNEL CAB

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KENYATAAN AKHBAR PIHAK BERKUASA PERANTI PERUBATAN 22 DISEMBER 2017 – PELANJUTAN TEMPOH MORATORIUM BAGI PENDAFTARAN PERANTI PERUBATAN DI BAWAH SEKSYEN 5 AKTA PERANTI PERUBATAN 2012 (AKTA 737)

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 VOLUNTARY LISTING OF TECHNICAL PERSONNEL, TRAINING BODY OR COMPETENCY CERTIFICATION BODY UNDER MEDICAL DEVICE ACT 737
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 APPLICATION FOR RENEWAL OF ESTABLISHMENT LICENSE
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  LIST OF LICENSED ESTABLISHMENT
  

More 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

 
 
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 2018

DEMONSTRATION LOG
               
TENDER / QUOTATION

KEPUTUSAN TENDER : MDA/TB01/2017 

KEPUTUSAN SEBUT HARGA : MDA/SH/01/2018

VACANCIES
No Vacancies Available
ONLINE SERVICES

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!
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