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
Medical device licensing is about to get simpler in Vietnam, with the introduction of a new Ministry of Health system that allows registrants to apply for import and product licenses via a single website. Starting January 1 2020, registrants will be able... Read More
Some medical devices already registered for sale in two of the five countries including Australia, Canada, the European Union, Japan or the United States for over one year that have not had serious adverse events will be eligible for quicker approval in... Read More
Moving to improve the safety of clinical trials, China’s Center for Drug Evaluation (CDE) has drafted new regulations on the timing, duration, and manner in which such trials are conducted. Under the new regulations, clinical trials would need to be initiated within... Read More
China’s National Medical Products Administration (NMPA) is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations, updated in October by the Ministry of Justice, reflect changes made to the Drug Administration Law... Read More
Malaysia’s Medical Device Authority in October revised its requirements for the labeling of medical devices. Under the new guidelines, devices must be labeled with a Malaysian medical device registration number within six months from their date of registration. Medical devices for home... Read More
Regulations on in-vitro diagnostic (IVD) medical devices expected to go into effect in 2020 in South Korea will establish a broad set of registration requirements for IVDs as part of a push to improve oversight of their safety and quality, according to... Read More
One year after Japan tightened its drug pricing system in a bid to make cutting-edge treatments more affordable, the restrictions threaten to slow drug sales to the country, a pharmaceutical industry leader warned last month. Under the new policy, announced in 2018,... Read More