Malaysia MDA Product Classification: Mandatory Online Submissions by August 2026

Medical Device Global Market Access · Jul 29, 2026 · 4m

Malaysia's Medical Device Authority (MDA) is mandating fully online submissions for all medical device product classification applications starting August 1, 2026. This episode details the transition to the new Product Classification Application System (PCAS), explains the impact on manufacturers seeking market access in Malaysia, and provides practical steps for regulatory teams to prepare for this digital-only process to avoid delays. Key Questions: - What is the new requirement from Malaysia's Medical Device Authority (MDA)? - When does the mandatory online submission for product…