Conformity Assessment Body

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 BODY REGISTRATION DATE

 MDA/CAB-001

 TÜV SÜD (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  TÜV RHEINLAND MALAYSIA SDN. BHD.  12/09/2017
 MDA/CAB-008  TÜV NORD (MALAYSIA) SDN. BHD.  12/09/2017
 MDA/CAB-009  CARE CERTIFICATION INTERNATIONAL (M) SDN. BHD.  12/04/2018
 MDA/CAB-012  CI INTERNATIONAL CERTIFICATION SDN. BHD.  10/04/2018
 MDA/CAB-013  KGS CERTIFICATION SDN. BHD.   30/09/2015 
 MDA/CAB-014  DNV GL INTERNATIONAL 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 
 MDA/CAB-018  NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. 18/12/2017
  *Please click the NAME OF CONFORMITY ASSESSMENT BODY to get more information.

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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