Beginning in September, Japan will enforce recently codified amendments to its Pharmaceutical and Medical Device Act, affecting quality management, device registration, the regulation of medical software and third-party certifications. The new requirements, designed to guard against health problems associated with poorly regulated... Read More
Two years after Taiwan’s Food and Drug Administration first proposed establishing dedicated regulations on medical devices, efforts to separate oversight of the growing industry from that of pharmaceuticals remain stalled. Since 1973, when Taiwan established the Pharmaceutical Affairs Act, regulations of medical... Read More
As China’s drug market grows exponentially, more foreign API, excipient and drug packaging material companies look to sell their products in China. In August 2016, to simplify the drug review procedure, the former CFDA announced that the review and approval of APIs,... Read More
Seeking to improve the safety, effectiveness, and oversight of medical devices, India’s government is again considering a series of laws that would establish a regulatory framework for medical technologies. But government health officials remain divided over which course to take to tighten... Read More
Healthcare facilities in Malaysia would be required to notify government authorities if they employ medical devices whose registration has lapsed, under a new guidance drafted by the country’s Medical Device Authority. The use of such “orphan” devices has been a recurring issue... Read More
Seeking to more effectively manage, distribute and ensure the efficacy of publicly funded vaccines, Chinese health authorities plan to institute a web-based national vaccine tracking system in the next three months. The system, piloted in seven major provinces last year, is designed... Read More
New drug therapies to treat serious and life-threatening diseases would be reviewed more quickly under draft regulations under consideration by China’s Center for Drug Evaluation (CDE). The proposed guidelines would allow for priority review and conditional approval of pharmaceuticals deemed to have... Read More
Medical device manufacturers could find doing business in Malaysia more costly if new registration fees currently under consideration by the country’s Medical Device Authority (MDA) are adopted. On the table are higher registration fees for all classes of medical devices, as well... Read More
Continuing its push to encourage the development of artificial intelligence (AI) products, South Korea is making it simpler for manufacturers to secure government approval of AI-based medical devices. In October, the Ministry of Food and Drug Safety announced that it would ease... Read More
Pushing to increase the ability of China’s medical institutions to conduct much-needed medical device and drug trials without sacrificing safety or quality, the National Medical Products Administration added more than 150 medical institutions to the list of those certified to host clinical... Read More