Comformity Assessment Body (CAB) - Speakers
CONFORMITY ASSESSMENT BODY REGISTRATION UNIT (CABRU)
Conformity Assessment Body Registration Unit (CABRU) is responsible for overseeing the registration, monitoring and continuous compliance of Conformity Assessment Bodies (CABs) designated under the Medical Device Act 2012 (Act 737) and its subsidiary regulations.
CABRU ensures that all designated CABs operate with the highest standards of competence, impartiality and integrity in assessing medical devices within the Malaysian regulatory framework. The unit plays a vital role in maintaining the credibility and reliability of conformity assessment process, thereby safeguarding public health and strengthening confidence in the national regulatory system.
The functions of the CABRU:
Evaluate and process applications for CAB designation in accordance with the Medical Device Regulations 2012 (Fourth Schedule).
Conduct regular inspections and performance review of CABs to ensure ongoing compliance, competence, and impartiality with regulatory requirements.
Contribute to the development of policies, guidance documents and procedures related to CAB registration and operations.
Facilitate stakeholder engagement and capacity-building programmes, such as MDA–CAB dialogues, workshops, training and regulatory reliance initiatives.
Provide technical and regulatory advice to MDA management, committees such as TEKCAB, CABAC and external stakeholders on CAB-related matters.
