Aqc Technical Assessors (M) SDN. BHD.
Medical Device Authority Documents
Frequently Asked Questions (FAQ)
Conformity assessment for medical devices approved by recognized countries. Medical Device need to undergo a simplified conformity assessment through the process of verification of evidence obtained from the manufacturer (verification process). Section 10 of Act 737 prescribes that conformity assessment of medical device shall be carried out by Conformity Assessment Body (CAB). The CABs shall be independent and impartial with regards to the performance of its conformity assessment duties as stipulated in Section 10(3)(a) of Act 737 and Paragraphs 9(2) and 9(7) of Fourth Schedule of Medical Device Regulations (MDR) 2012.
For details, please refer to document:
Circular Letter 2/2014, Appendix 1-Revision 3.
For details, please refer to document:
Circular Letter 2/2014, Appendix 1-Revision 3.
Medical devices which have not been subjected to conformity assessment and have not obtained any approval in accordance with the requirements stipulated in Section 7(1)(a) of Act 737. The manufacturer’s responsibility to provide evidence that the medical device is safe and performs as intended by the manufacturer.
For details, please refer to document:
MDA/GD/0031 – Conformity Assessment for Medical Device
For details, please refer to document:
MDA/GD/0031 – Conformity Assessment for Medical Device
Good Distribution Practice for Medical Devices (GDPMD) is made pursuant to Appendix 4 of Schedule 3 of the Medical Device Regulation 2012 and is applicable to all parties involved in the supply-chain of medical device covering authorized representatives of foreign manufacturers, importers or distributors of medical devices in Malaysia. It does not cover manufacturers and retailers of medical devices.
For details, please refer to document:
MDR/RR No 1: November 2015 – Good Distribution Practice for Medical Devices (GDPMD)
For details, please refer to document:
MDR/RR No 1: November 2015 – Good Distribution Practice for Medical Devices (GDPMD)
For details, please refer to document :
MDA/GL No. 2 – How to apply for establishment License under the medical device act 2012 ( Act 737)
MDA/GL No. 2 – How to apply for establishment License under the medical device act 2012 ( Act 737)
An importor is a person or company appointed by an AR (for medical devices manufactured in a foreign country) or a manufacturer (for locally manufactured medical devices) to further medical devices registered by the AR or the manufacturer into the Malaysian market. A distributor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an establishment license to conduct its activity.
A distributor is a person or company appointed by an AR (for medical devices manufactured in a foreign country) or a manufacturer (for a locally manufactured medical devices) to further medical devices registered by the AR or the manufacturer into the Malaysian market. A distributor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an establishment license to conduct its activity.