In a much-awaited update, Malaysia’s Medical Device Authority (MDA) has launched a streamlined online registration system designed to make it simpler and more efficient for foreign manufacturers to register their medical device products to access the country’s market.
The updates to the MDA’s online application portal, MeDC@St, went into effect on February 1. The updates allow applicants to use the same submission identification number for various product categories and offer simpler forms for submissions. Payment, until now required via bank draft and FPX, will now facilitate credit cards, and applicants will be able to report progress on device studies via the online system.
The updates are a significant advance to an outdated application and reporting system that had caused massive backlogs since the country’s medical device regulatory system was first established on a voluntary basis in 2012. The first mandatory device licenses were issued by Malaysia in 2016.
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://assets.kpmg.com/content/dam/kpmg/jp/pdf/2020/jp-medical-device-apac-en.pdf