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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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 PUBLIC COMMENT FOR GUIDANCE DOCUMENT ON REQUIREMENTS FOR CONFORMITY ASSESSMENT BODY (CAB) REGISTRATION
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 IKLAN JAWATAN KOSONG PENOLONG PEGAWAI PENERANGAN S29 (PSH)
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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. 1 YEAR 2018

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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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 MALAYSIA MEDICAL DEVICE EXPO 2018 REGISTRATION  

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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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FIELD SAFETY NOTICE:  TGA SUSPENSION OF SUPPLY NOTICE – COVIDIEN/MEDTRONIC PURITAN BENNET (PB980) VENTILATOR

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 CUSTOMER SATISFACTION SURVEY 

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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

TENDER / QUOTATION

TAWARAN SEBUT HARGA PEMBEKALAN CENDERAHATI BAGI PIHAK BERKUASA PERANTI PERUBATAN (PBPP) :MDA/SH/02/2018


KEPUTUSAN TENDER : MDA/TB01/2017 

KEPUTUSAN SEBUT HARGA : MDA/SH/01/2018

VACANCIES

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

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 

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