Malaysia’s medical device regulatory framework, governed by the Medical Device Authority (MDA), continues to evolve with increasing emphasis on pre- and post-market compliance. Whether you are registering a low-risk (Class A) product or a moderate-to-high-risk (Class B, C, or D) device, understanding... Read More
In recent months, China has proposed and implemented several key reforms to its medical device regulatory framework, indicating a broader strategy to reshape how foreign and domestic medical products are evaluated, approved, and monitored. These changes reflect an ongoing effort by the... Read More
Over the past year, Japan has introduced a series of regulatory reforms aimed at modernizing and accelerating the approval and reimbursement pathways for medical devices, especially Software as a Medical Device (SaMD) products. These reforms are part of Japan’s broader effort to... Read More
In the past year, Korea has launched an ambitious suite of pharmaceutical regulatory reforms designed to accelerate drug approvals, foster innovation, and improve patient access to essential medicines. As the Ministry of Food and Drug Safety (MFDS) faces criticism over protracted review... Read More
Japan’s pharmaceutical regulatory landscape is undergoing significant transformation in 2025, driven by a collective push to reduce Japan’s drug lag, enhance clinical trial systems, modernize post-approval processes, and support innovative therapies. These changes – initiated by the Ministry of Health, Labour and... Read More
China’s pharmaceutical sector has been undergoing significant transformations in the past year, with sweeping reforms affecting drug reimbursement, approval processes, market access pathways, and the oversight of pharmaceutical representatives. Together, these policy shifts aim to enhance access to high-quality treatments, increase efficiency... Read More
Japan’s healthcare system is known for its efficiency and centralized regulation, which also extends into its medical device reimbursement process. For foreign and domestic manufacturers alike, understanding Japan medical device reimbursement framework is essential for successful market entry and sustained commercial success.... Read More
Japan maintains one of the most rigorous and structured Good Manufacturing Practice (GMP) compliance frameworks globally. Designed to ensure the safety, efficacy, and quality of drugs and quasi-drugs, Japan’s GMP regime is enforced by the Pharmaceuticals and Medical Devices Agency (PMDA), under... Read More
South Korea has long stood at the forefront of technological advancement in Asia, with a robust healthcare system and a rapidly growing digital health ecosystem. In line with its reputation as a global innovator, South Korea has recently introduced several major regulatory... Read More
Introduction Singapore’s medical device regulatory framework is considered one of the most transparent and robust systems in the Asia-Pacific region. Managed by the Health Sciences Authority (HSA), the regulatory process aims to ensure the safety, efficacy, and quality of medical devices entering... Read More