Fees to register and obtain licenses for the sale of medical devices in Taiwan will increase next year, the country’s Food and Drug Administration (TFDA) announced in August. Under the new fee structure, registration fees for Class I devices will increase from... Read More
Medical software programs used to prevent, manage, or treat diseases based on clinical evidence are subject to new guidelines for obtaining the approval of regulators in Korea. The guidelines on the Korean digital therapeutics programs cover their definition and scope, criteria for... Read More
This article was originally published on MedTech Intelligence China In China, where the vast medical device market was valued at more than $40 billion in 2019, authorities have moved to secure the safety and efficacy of medical devices while at the same... Read More
Background information Japan is the third-largest drug market in the world with a market size of about $95 billion in 2019. With about 30% of the population over 65 years old, it has a very large number of people who need drugs. Healthcare... Read More
Introduction to China’s Drug Market Everyone has been talking about opportunities in China’s drug market the last 5 years. While the size of the drug market in China varies, we estimate it at about $140 billion dollars now and growing about 10%... Read More
Medical device manufacturers seeking to market devices in China will be required to adhere to new guidelines in the risk assessments they submit to authorities, the National Medical Products Administration (NMPA) announced in August. The periodic risk assessment reports, which outline possible... Read More
Changes to pharmaceutical registration regulations in China that went into effect July 1 make clear that Market Authorization Holders designated by the country’s regulatory authority to market or distribute a product are responsible for the safety, quality, and efficacy of that product... Read More
In the wake of a 2019 antibiotic shortage which cast light on the country’s dependence on overseas suppliers of the essential drugs, Japan’s Ministry of Health, Labor and Welfare is proposing a series of measures to ensure stability in its supplies of... Read More
South Korea is pushing to standardize international regulations on medical devices fueled by artificial intelligence technologies and to eliminate structural barriers to marketing those and other innovative medical device technologies. In July, Eui-Kyung Lee, who heads Korea’s Ministry of Food and Drug Safety, pushed... Read More
In a bid to better standardize its assessment of medical devices, China’s Center for Medical Device Evaluation has published revised catalogs of medical devices and in vitro diagnostic reagents that are exempt from clinical trials. The “New and Revised Catalogue of Medical... Read More