Malaysia Now Offers New Medical Device Consultation Services

In the past, it was not possible to meet Malay MDA officers face-to-face. They were always resource-constrained and did not have time. However, on August 2, Malaysia’s MDA announced new consulting services for device manufacturers seeking medical device registration approval in Malaysia. Two types of regulatory consulting services are now available – 1. Consulting package services and 2. Non-package consulting services. For the consulting packaging services, applicants must fill in an application form and choose between five package offerings including – 1. Development of GDP for medical devices, 2. Establishment License application, 3. Medical device registration online application via Medic@st System PAC, 4. Medical device exemption notification, and 5. Medical device risk classification and grouping. For non-package consulting services, some of the same services are offered plus other topics like medical device advertising regulations, labeling, etc. Consultations can be done in person or online, and each service has a specific government fee that will need to be paid.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://portal.mda.gov.my/industry/pre-market-consultation.html