Friday, 10, April, 2026 / Published in Blog, Malaysia, Medical Devices, Pharma & Biotech

Malaysia Drug–Medical Device Combination Products: A Guide to Classification & Regulatory Pathways

Drug–medical device combination products present a unique regulatory challenge in Malaysia because they combine two product categories that are traditionally…

Tuesday, 3, February, 2026 / Published in Blog, Malaysia, Medical Devices, Medical Devices, Medical Devices, Singapore, Vietnam

Medical Device Market Access in ASEAN: Malaysia, Singapore, and Vietnam Compared

Medical device market access in ASEAN has become a strategic priority for international manufacturers seeking sustainable growth in Southeast Asia.…

Monday, 13, October, 2025 / Published in Blog, Malaysia, Medical Devices

Malaysia Conformity Assessment Body Explained: Key Insights into Medical Device Approval

Expanding into Malaysia’s growing medical device market offers tremendous opportunities. However, depending on your device’s classification, success can hinge on…

Friday, 12, September, 2025 / Published in Blog, Indonesia, Malaysia, Medical Devices, Medical Devices, Medical Devices, Medical Devices, Medical Devices, Medical Devices, Singapore, Thailand, The Philippines, Vietnam

Understanding Medical Device Registration Validity in Southeast Asia

Medical device registrations across Southeast Asia are subject to strict validity rules and renewal requirements, with timelines ranging from two…

Thursday, 11, September, 2025 / Published in Blog, Cosmetics & Ingredients, Malaysia

Malaysia Cosmetic Product Registration: NPRA Notification Process

Cosmetic product registration in Malaysia is explained in this guide, which details the end-to-end pathway for manufacturers to place a…

Tuesday, 26, August, 2025 / Published in Blog, Indonesia, Malaysia, Medical Devices, Medical Devices, Medical Devices, Singapore, Thailand, The Philippines, Vietnam

Fast-Track Medical Device Registration in Southeast Asia with Timelines and Market Entry Strategies

Medical device registration in Southeast Asia is often a major challenge for manufacturers from the US, Europe, and other regions,…

Tuesday, 19, August, 2025 / Published in Blog, Malaysia, Medical Devices

Medical Device Registration in Malaysia: A Practical Guide for Foreign Manufacturers with Latest Timelines, Fees & Tips

Malaysia’s medical device registration framework, built around the Medical Device Act 2012 and overseen by the Medical Device Authority (MDA),…