A generative AI medical device is medical software built on large language models. It can review different types of health information, such as clinical notes, images, and lab results, and produce new content, such as a summary or an answer to a... Read More
China’s National Medical Products Administration (NMPA) has drafted measures to grant market exclusivity to qualifying rare disease and pediatric drugs. During the exclusivity period, NMPA would not approve competing products of the same variety. A rare disease drug would qualify if it... Read More
Singapore’s Ministry of Health (MOH) and Health Sciences Authority (HSA) announced on October 12 several measures to get new drugs and medical devices to patients faster. Starting in early 2027, clinical trial sponsors will get more hands-on help, including earlier regulatory consultations... Read More
Korea’s Ministry of Health and Welfare (MOHW) plans to announce in November which rare disease drugs it has selected for a pilot program to list these treatments on national health insurance within 100 days. Eleven drugs made the shortlist, and three were... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a set of notifications on September 30 to prepare drugmakers for the May 20, 2027 start of new legal rules on risk management plans (RMPs) under the amended Pharmaceuticals and Medical Devices (PMD)... Read More
China’s legislature approved the Healthcare Security Law on August 28, 2026, and it will come into effect at the start of 2027. The law formally brings medical devices and consumables into the national insurance coverage system alongside drugs. Until now, medical device... Read More
On October 5, 2026, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) published an early-consideration guidance on developing companion diagnostics (CDx) in parallel with cancer drugs. Japan already expects a CDx and its matching drug to be filed at about the same time.... Read More
Malaysia’s Medical Device Authority (MDA) announced changes to its Medical Device Product Classification Application System (PCAS) and to how long product classification letters stay valid. The changes took effect on October 1. The upgraded PCAS uses a simplified online form. Applicants now... Read More
In China, a newly registered medical device usually waits one to two years before hospitals can bill for it under insurance. Much of that delay comes from creating a medical service price item, which only begins after product approval. A pilot launched... Read More
Indonesia’s Ministry of Health has published its first guidance written specifically for software medical devices. The guidance explains how developers can obtain a marketing license and covers three groups – standalone software (SaMD), software that runs or controls a physical device (SiMD),... Read More