Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective... Read More
India’s health ministry has put together a proposal to overhaul the country’s pharmaceutical rulebook, much of which has been in place since 1940. The draft Drugs, Medical Devices and Cosmetics Bill 2026 will reshape how the country brings new drugs and devices to market and manages... Read More
India’s Central Drugs Standard Control Organization (CDSCO) released its finalized Guidance Document on Medical Device Software (The Guidance Document) on July 21, 2026. The Guidance Document provides comprehensive guidance dedicated to the regulation of medical device software (MDSW) under India’s existing Medical... Read More
India’s Ministry of Health and Family Welfare has proposed amendments to the 2017 Medical Devices Rules to simplify and speed up the licensing process for medical device manufacturing. A draft notification was published in the Official Gazette for public comment, with the... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) revised its digital medical device labeling guidelines on June 10. The update follows industry difficulties after the Digital Medical Products Act took effect in January 2025. Key changes include a grace period permitting previous... Read More
India is taking efforts to strengthen the safety oversight of healthcare products. One key initiative is the establishment of a national registry for implantable medical devices, such as cardiac stents and orthopedic implants. The registry will allow regulators and healthcare providers to... Read More
India’s Central Drugs Standard Control Organisation (CDSCO) has announced that product applications will be rejected if applicants fail to respond to official regulatory queries within 90 days of receiving the first reminder. The CDSCO aims to clear long-pending applications across drugs, medical... Read More
In late December, Malaysia’s Ministry of Health (MOH) announced a new requirement regarding the use of a FarmaTag hologram security label on drug products. The measure is intended to strengthen labeling and authentication requirements. Also, it will enhance safeguards against counterfeit medicines and improve... Read More
India’s Department of Biotechnology (DBT) is developing plans to introduce “regulatory sandboxes” for the pharmaceutical sector to fast-track approvals and shorten drug development timelines. A sandbox would allow innovators to test drug products with more relaxed regulatory requirements. The goal of this initiative... Read More
India’s Central Drugs Standard Control Organization (CDSCO) has released the final list of risk classifications for oncology-related medical devices. The classification system, published on January 2, 2026, improves transparency concerning the regulation of cancer med-tech devices. It gives manufacturers of oncology devices... Read More