TÜV SÜD Malaysia is a licensed CAB under Malaysia’s MDA, authorised to evaluate and certify applications for medical device registration in Malaysia.
We offer technical file review by Full Conformity Assessment or Conformity Assessment by Product Verification, and we are qualified to conduct audits of a manufacturer’s quality management systems, as required by the provisions of the MDA which include Good Distribution Practice of Medical Device (GDPMD) and ISO 13485.
Besides, our ISO 17025 and GLP certified laboratories provide biocompatibility studies, product safety and reliability testing for medical devices according to relevant standards. We also conduct factory audits to test compliance with international standards for other quality management systems, including ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 27001, IATF 16969, ESD 20.20, and others.
We are a trusted service provider for companies ranging from global manufacturers to regional and local firms. Our extensive international network makes us an effective partner for manufacturers seeking global market access for their products. A Regulatory Foreign Affairs and Clinical Centre of Excellence adds to our expertise.
Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees. TÜV SÜD is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognized Notified Body, while our testing services are conducted through TÜV SÜD Testing Labs.