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
Several years after it piloted a MAH system for medical devices in 4 locations in China, the government is expanding the pilot to 21 provinces/municipalities. The expanded Medical Device Marketing Authorization Holder (MAH) program will offer scientists and pharmaceutical research and development institutions... Read More
Broadening its oversight of clinical trials for which it has become a regional hub over the past decade, South Korea this August announced a five-year plan to broaden testing opportunities for new drugs while better protecting the rights of patients participating in... Read More
As electronic labeling of pharmaceuticals and therapeutic products becomes more prevalent, Singapore’s Health Science Authority this summer issued guidelines to ensure the labeling systems provide needed information to consumers and regulators. The electronic labels—often dependent on USSD codes that link to labels... Read More
China’s Center for Medical Device Evaluation (CMDE) has expanded the number of medium and high-risk medical devices exempt from clinical requirements. The new list includes 142 more medical devices than were previously exempted. Manufacturers of Class II and Class III medical devices... Read More
A growing number of Association of Southeast Asian Nations (ASEAN) member states are coming into compliance with medical device requirements they first pledged to work towards in 2015. Under the ASEAN Medical Device Directive (AMDD), the 10 ASEAN nations agreed to bring... Read More
Moving to centralize decision-making on drug reimbursement practices, China’s National Healthcare Security Administration has drafted a plan to decrease the ability of provincial governments to make adjustments to the prices of pharmaceuticals. The agency, which since its formation last November has played... Read More
Four years after China established a pilot program enabling drug license holders to use third parties to manufacture their products, the National Medical Products Administration in August launched a database to allow drug makers and the public to more easily access information... Read More
A pilot program to streamline approvals of some medical devices will kick off this September, according to Hong Kong’s Medical Device Control Office (MDCO). Under the trial program, Class II, Class III and Class IV general medical devices will be eligible for... Read More
Moving to put the brakes on soaring medical device costs, India’s health ministry is floating a proposal to cap prices on commonly used products including stents, catheters, and some medical implants. If the changes under study are approved, price controls would be... Read More