Overview

Malaysia medical device industry is booming as the Malaysian government making it conducive for global players. The country greatly relies on foreign manufacturers for high-end Medical Devices. They are regulated by Malaysian Medical Device Authority (MDA) functioning under Ministry of Health Malaysia (MoHM). The Regulatory sieving begins with classification as A, B, C or D based on risk of the device followed by review by MDA authorized conformity assessment bodies (CAB). Procuring a dependable local agent with an establishment license, and maintaining post-approval activities actively are tasks that further burden manufacturers with huge investments.

Freyr extends auxiliary support for manufacturers with Device Classification, conformity assessment for certification and extends support throughout the Regulatory process. Freyr helps foreign applicants to procure a suitable local agent with industry relevance. Freyr, with long-standing experience, effectively handles the post-marketing surveillance activity of Medical Devices in Malaysia.

Malaysia Market Entry for Medical Devices - Process Flow