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 Freyr Expertise Regulatory Guidance for Registration Medical Device Classification Malaysian Local Representation Service Regulatory Support in Adhering to Good Distribution Practice Medical Devices (GDPMD) Dossier/Document Compilation Post-Market Surveillance Summary S.No Regulatory Parameter Malaysia 1 Regulatory Authority Malaysian Medical Device Authority (MDA) 2 Regulation Act 737, Medical Device Act 2012 3 Risk Classification Class A Class B Class C Class D 4 Regulatory Pathway Class A Online Application Class B, C & D CAB Review + Online Application 5 Authorized Representative Malaysian Representative required 6 Fee payable Class A $25* Class B $320* Class C $640* Class D $960* 7 QMS Requirement ISO 13485 8 Assessment of Technical Data Conformity Assessment Body (CAB) 9 Validity of License 5 Years 10 Labelling Requirements Schedule VI of Medical Device Rules 2012 11 Submission format Online (MeDC@St) 12 Final Outcome Registration Certificate 13 Timelines 1 - 9 Months 14 Language English *The price is as per records at the time of documentation and is subject to change.