Good Manufacturing Practice (GMP) compliance is required for drug registration approval in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) conducts GMP inspections at foreign manufacturing sites to verify adherence to Japan’s GMP ordinance (MHLW Ordinance No. 179, 2004). This article provides... Read More
Japan’s medical device regulatory landscape underwent a significant transformation with the revision of its Quality Management System (QMS) requirements under the Pharmaceutical and Medical Device Act (PMD Act) in 2015. The updated QMS ordinance introduced new inspection types, registration requirements, and harmonization... Read More
India’s rapidly growing healthcare sector and large population present significant opportunities for global medical device manufacturers. However, navigating India’s regulatory landscape, particularly the requirements of the Central Drugs Standard Control Organization (CDSCO), is critical for market entry and long-term success. As the... Read More
Regulatory Authorities and Legal Foundations Indonesia’s medical devices and in vitro diagnostics (IVDs) are regulated by the Indonesian Ministry of Health (MoH), specifically its Directorate General of Pharmaceutical and Medical Devices. Registration and licensing are required for all imported or domestically manufactured... Read More
Vietnam’s pharmaceutical sector has experienced consistent growth over the past decade, spurred by rising healthcare demands, government initiatives to modernize the healthcare system, and increased foreign investment. For international pharmaceutical companies aiming to enter this emerging market, a deep understanding of Vietnam’s... Read More
As medical technologies evolve at lightning speed – integrating artificial intelligence, wearable tech, and patient-directed innovations – regulatory agencies worldwide are working to keep pace. Thailand is no exception. Over the past decade, the country has introduced reforms to its medical device... Read More
Vietnam is one of the fastest-growing healthcare markets in Southeast Asia, making it an attractive destination for global medical device manufacturers. With a population exceeding 98 million and a healthcare system undergoing modernization, the demand for advanced medical technologies is rising steadily.... Read More
Introduction Japan’s pharmaceutical market remains one of the largest and most attractive healthcare markets globally, presenting unique opportunities as well as specific regulatory challenges for foreign pharmaceutical companies looking to enter or expand their presence there. Successfully navigating the intricacies of drug... Read More
Thailand’s pharmaceutical sector is expanding rapidly, fueled by a growing healthcare market and an evolving regulatory environment that aims to balance safety, innovation, and accessibility. For companies seeking to enter the Thai pharmaceutical market, understanding the regulatory framework is crucial – particularly... Read More
Singapore continues to assert itself as a regional leader in medical device regulation, innovation, and cybersecurity preparedness. Over the past year, the Health Sciences Authority (HSA), along with other regulatory and policy bodies in Singapore, introduced and revised several key platforms governing... Read More