Frequently Asked Questions - Registration, Licensing & Enforcement
Frequently asked question about Registration, Licensing & Enforcement
Medical device registration number shall be available on the outer box/external packaging. A search can also be made via Medical Device Authority Register (MDAR) mdar.mda.gov.my
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)
| REGISTRATION NO. | NAME OF CONFORMITY ASSESSMENT BODY | REGISTRATION DATE |
|
MDA/CAB-001 |
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. | 18/12/2 |
Any regulatory training under Act 737 is part of MDA Training Programme. MDA has not authorize any party to conduct such training and MDA shall not be liable for any inaccuracies or misinterpretations of the contents of the training conducted by any party other than MDA.
List of Registered Conformity Assessment Body (CAB)
Please click link below to check list of registered Conformity Assessment Body (CAB):
https://mda.gov.my/industry/conformity-assessment-body-cab/status.html
Applicants may begin to register now or within 6 months of the SA/CA approval letter's expiration date.
