All You Need to Know About the Conformity Assessment Bodies (CABs) for Malaysian Market Access of your Device – Part 1
The Conformity Assessment Body (CAB) plays a vital role in issuing various certifications and carrying out technical assessments required for successful registration and distribution of your medical devices and IVDs.
This part of the blog series introduces the Medical Device Authority (MDA's) requirement for CAB certification. The of the series will take you through the role of CABs in device registration and approval in Malaysia.
The CABs are entitled to perform the assessments under the below regulations -