Medical devices in Thailand will be classified in accordance with the risk they pose to patients and the public, under a new categorization system announced by the Ministry of Public Health. The move to create four categories each for both in vitro... Read More
This article was originally published on MedTech Intelligence. Driven by an aging population with growing needs for new medical technologies—and more means to pay for them—governments and hospitals in China, Japan, Singapore, Thailand and Korea are joining forces to purchase an increasing... Read More
Some medical devices already registered for sale in two of the five countries including Australia, Canada, the European Union, Japan or the United States for over one year that have not had serious adverse events will be eligible for quicker approval in... Read More
Fueled by high sugar diets, processed food, misinformation and a dearth of early intervention, the prevalence of Type 2 diabetes is a persistent public health crisis in Southeast Asia. One of every 14 people in Indonesia, Malaysia, Singapore, and Thailand has some... Read More
In Thailand, medical devices are categorized in 1 of 3 classes in accordance with the ASEAN Medical Device Directive (AMDD). Sometimes, it is difficult to tell if a product is a medical device or not. In some cases, devices may have drug... Read More
The Thai Food and Drug Administration (FDA) in June issued a series of amendments to its Medical Devices Act, which regulates the use and sale of medical devices in the country. Among the 16 new clauses enacted in June are prohibitions on... Read More
As demand skyrockets for healthcare in Southeast Asia, remote medical provider technologies are becoming increasingly popular. The technologies, which include app-based medical consultations and other telehealth options, allow doctors to reach more patients, especially in remote areas where access to healthcare providers... Read More
Thailand’s Food and Drug Administration is tightening requirements and raising fees for the registration of new drugs. The changes were published in Thailand’s Government Gazette in April as Drug Act (No. 6) B.E. 2562 and go into effect in October, 2019. They... Read More
This article was originally featured on Medtech Intelligence. As Asia’s prostate cancer burden grows, so do opportunities for Western medical device companies with products to diagnose and treat the disease. Leading Western medical device firms are moving into markets across the Asian... Read More
With rates of hepatitis B infection higher in Asia than anywhere else on the globe, deaths from liver cancer are an overwhelmingly Asian phenomenon. Almost 80 percent of cases and deaths from liver cancer occur on the Asian continent, according to the... Read More