TÜV SÜD Malaysia, a globally recognized quality and safety testing, inspection, certification and auditing organization, is now officially accredited as a Conformity Assessment Body (CAB) for Medical Device Authority (MDA) in Malaysia. This qualification allows TÜV SÜD’s experts to conduct conformity assessments on quality management systems for Medical Devices and product approval reviews in compliance with the Medical Device Act 2012.
In the heavily regulated Medical Device industry, key factors include the competency of auditors in carrying out accurate and reliable assessments and the existence of a robust system to safeguard the impartiality of a CAB.
In order to achieve CAB status, TÜV SÜD Malaysia had to fulfill stringent requirements to gain the MDA’s approval. With the accreditation, TÜV SÜD experts are now qualified to provide assessments on quality management systems (ISO 13485), 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. Medical Device manufacturers can now depend on TÜV SÜD Malaysia as an accredited third-party Conformity Assessment Body for a comprehensive suite of Medical Device certification services in compliance with the Medical Device Act 2012.