Quick Asia Regulatory Updates (April 2026)

A new trade agreement between the United States and Taiwan includes measures to expedite the regulatory review of innovative pharmaceuticals and medical devices manufactured in the US. Under the agreement, approval from the US Food and Drug Administration may be used as key supporting evidence when applying for marketing authorization with the Taiwan Food and Drug Administration (TFDA). While Taiwan will continue to conduct its own regulatory review, this approach is expected to streamline the evaluation process and enable faster patient access to innovative therapies and medical technologies. The agreement also calls for greater transparency and predictability in reimbursement under Taiwan’s National Health Insurance system. These changes are expected to improve patient access to new treatments while strengthening pharmaceutical and medical device cooperation between the two countries.

Korea’s Ministry of Food and Drug Safety (MFDS) has revised its Guideline on Classification and Class Designation for Digital Medical Devices to support earlier prediction of device classification during development. Digital medical devices are categorized into four classes (1–4) based on patient risk, impact on diagnosis and treatment, and potential harm if performance declines. The updated guideline clarifies classification criteria by incorporating examples from recent approval cases. For instance, emergency decision support for acute myocardial infarction and stroke is classified as Class 4. Applications such as sleep apnea screening and insulin dose recommendations are designated as Class 2. The revision also introduces a flowchart to streamline the classification process. The MFDS noted that the update will enable developers to determine device class more efficiently at early stages.