Services

AQC TECHNICAL ASSESSORS (M) SDN. BHD. is approved as a Conformity Assessment Body (CAB) by Medical Device Authority – Ministry of Health Malaysia. Our talented professional provide assessments and verification on Medical Devices General Medical Devices and In vitro Diagnostic medical devices with stringent quality and approvals based on relevant Malaysian regulatory requirements . Regulatory […]

All Malaysian establishments, ie manufacturer, authorised representative (AR), importer and distributor must apply for establishment licence. However, only manufacturer and AR need to apply for medical device registration. The validity of the establishment licence is 3 years and an establishment can start to renew the licence 1 year prior to expiry date. Based on the […]

Good Distribution Practice for Medical Devices (GDPMD) is by ensuring the quality, safety and performance of medical device during all aspects of medical device supply-chain, which include, but not limited to, product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration and after sales service; tracking, documentation and record-keeping practices. The […]

ISO 13485:2016 Safety and quality are non-negotiable in the medical devices industry, that’s why ISO 13485 is developed. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they […]

Online training (coming soon)