TÜV SÜD PSB Malaysia accredited as Conformity Assessment Body for Medical Devices Authority
MALAYSIA – TÜV SÜD PSB Malaysia, a globally recognized quality and safety testing, inspection, certification and auditing organisation, is now officially accredited as a Conformity Assessment Body (CAB) for Medical Device Authority (MDA) in Malaysia. This qualification allows TÜV SÜD PSB’s experts to conduct conformity assessments on medical devices quality management systems and product approval reviews in compliance to the Medical Device Act 2012.
In the heavily regulated medical device industry, competency of auditors in carrying out accurate and reliable assessment are key besides having in place a robust system to safe guard the impartiality of a CAB. In order to achieve CAB status, TÜV SÜD PSB Malaysia had to fulfill stringent requirements to gain MDA’s approval. With the accreditation, TÜV SÜD PSB experts are now qualified to provide assessments on Quality Management Systems (ISO13485), Good Distribution Practice of Medical Device (GDPMD) and product approval reviews.
“The Medical Device Authority is charged with the responsibility to protect the public health and safety of consumers by ensuring that medical devices in Malaysia are safe and of high quality. As one of the accredited third-party conformity assessment bodies, medical device manufacturers can now depend on TÜV SÜD PSB for a comprehensive suite of medical devices certification services in compliance to the Medical Device Act 2012. Being the largest notified body in medical device industry, our clients can also tap on our worldwide network of expertise. This will go a long way in safeguarding the brands of medical device manufacturers and assure their clients about the quality and safety of their products,” said Mr. Chia Jen Wen, General Manager, TÜV SÜD PSB Malaysia.