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We wish to inform that we have received applications from several organisations to become registered conformity assessment body (CAB) under the Medical Device Act 2012 (Act 737). Currently we are in the midst of evaluating these applications.

However, in the meantime, we notice that some companies are offering training on regulatory requirements of Act 737 including GDPMD. We would like to emphasise that any regulatory training under Act 737 is part of MDA Training Programme. We have never given any authority to anyone or any company to conduct such training and we shall not be liable for any inaccuracies or misinterpretations of the contents of the training conducted by parties other than MDA.


List of Registered Conformity Assessment Body (CAB)

Medical Device Act 2012 (Act 737, Section 10(1) and Regulation 8, Medical Device Regulation 2012
   
REGISTRATION NO.  NAME OF CONFORMITY ASSESSMENT BODYREGISTRATION DATE

 MDA/CAB-001

 TUV SUD (MALAYSIA) SDN. BHD.

 21/11/2016

 MDA/CAB-002 MEDCERT MALAYSIA SDN. BHD. 21/11/2016
 MDA/CAB-003 SGS MALAYSIA SDN. BHD.  21/11/2016
 MDA/CAB-004 SIRIM QAS INTERNATIONAL SDN. BHD.   21/11/2016
 MDA/CAB-005 BSI SERVICES MALAYSIA SDN. BHD  21/11/2016
 MDA/CAB-006 DQS CERTIFICATION (M) SDN. BHD.  12/09/2017
 MDA/CAB-007 TUV RHEINLAND MALAYSIA (M) SDN. BHD.  12/09/2017
 MDA/CAB-008 TUV NORD (M) SDN. BHD.   12/09/2017
 MDA/CAB-009 CARE CERTIFICATION INTERNATIONAL (M) SDN. BHD.  13/02/2015
 MDA/CAB-010 NQA CERTIFICATION SERVICES (M) SDN. BHD.  13/02/2015
 MDA/CAB-011 BUREAU VERITAS CERTIFICATION (M) SDN. BHD.   25/02/2015
 MDA/CAB-012CI INTERNATIONAL CERTIFICATION SDN. BHD.  23/04/2015
 MDA/CAB-013 KGS CERTIFICATION SDN. BHD.  30/09/2015
 MDA/CAB-014 DNV GL MALAYSIA SDN. BHD.  30/09/2015
 MDA/CAB-015 PLATINUM SHAUFFMANTZ VERITAS SDN. BHD.  23/12/2015
 MDA/CAB-016 GENUINE DIAMOND SDN. BHD.  23/12/2015
 MDA/CAB-017 ITC ZENITH (M) SDN. BHD. 14/04/2017

  *Please click the NAME OF CONFORMITY ASSESSMENT BODY to get more information.
Last Updated ( Monday, 16 October 2017 )
 
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