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DRAFT OF GUIDANCE DOCUMENT: 

DISTRIBUTION RECORDS read more..  


NEW RELEASE POLICY AND AND GUIDANCE DOCUMENT

1) Circular Letter MDA No. 7 Year 2015: Fast Track Medical Device Registration During Transitition Period read more..
2)  FAST TRACK Guidance Document  read more..  


MEDICAL DEVICE GUIDANCE DOCUMENT ON REQUIREMENTS FOR INSTALLATION, TESTING & COMMISSIONING AND ACCEPTANCE OF MEDICAL DEVICE read more...

 


Slide Presentation: PROGRAM TAKLIMAT KAWALAN PERANTI DI HOSPITAL QUEEN ELIZABETH, SABAH PADA 10.03.2015  read more..  



Medical Device Authority (MDA) is pleased to invites you to attend

“SEMINAR BERSAMA INDUSTRI PERANTI PERUBATAN 2015” 

which will be held as follows: read more ...


REGISTRATION OF MEDICAL DEVICE UNDER MEDICAL DEVICE ACT 2012 (ACT 737) read more ..

 


NOTIFICATION OF LOW RISK MEDICAL DEVICES http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif 

Referring to the Circular Letter No. 3 Year 2014 (Exemption of Medical Device from Registration), please be informed that all Class A medical devices which are non-active, non-sterile and has no measuring function are exempted from registration requirements. read more...

ATTENTION!http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif 

LATEST INFORMATION ON CONFORMITY ASSESSMENT BODY

For further information, please click here



Last Updated ( Friday, 17 April 2015 )
 
 
TENDER/SEBUT HARGA
Tawaran Tender PBPP/TT 01/2015 bagi Pihak Berkuasa Peranti Perubatan 
ONLINE SERVICES

is a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit.

CIRCULAR LETTER

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). The policies are as follows: read more ...

GUIDELINE DOCUMENTS
GUIDANCE DOCUMENTS

Guidance Documents are prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing the establishment license and medical device registration applications required under the Medical Device Act 2012 ( Act 737). CLICK HERE!

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