In February, Vietnam issued new labeling requirements for goods including medical devices via Decree 111. Medical device labels in Vietnam must include both the owner (name and address) and the owner of the registration number (name and address). If the device does... Read More
The United States Trade Office released its annual report in February. In the report, they discuss the fact that China is not being open to trade for medical devices and strongly supports locally made products. The report focused on volume-based procurement (VBP) and how China... Read More
On March 1, the Japanese cabinet issued a draft bill which creates an emergency approval system for devices and drugs. The draft will make it easier for these medical products to receive approvals based on presumed efficacy if there is an emergency. For... Read More
Due to the COVID-19 pandemic several years ago, The Korean Ministry of Food and Drug Safety (MFDS) stopped its on-site inspections of drug maker’s foreign manufacturing plants. In March 2022 however, the Ministry announced that it was going to resume in-person inspections from April to November this year. Around 50... Read More
A unique confluence of key factors fuels China’s leadership and momentum ahead of the US in AI health technology. A combination of massive data availability, low-cost labor to prepare this machine learning information, and the need to offset doctor shortages contribute to growth in this... Read More
In an effort to expedite the device registration process, the Thai FDA has ended the pre-submission stage of the Thai application process. Previously, applicants for Thai device approval had to provide basic information about the product and wait for the TFDA’s response to determine its specific grouping and classification. However, today with the... Read More
Malaysia’s MDA regulatory body, founded a decade ago, has concluded the public comments period for parties interested in submitting feedback on its new medical device guidance, MDA/GD/0009. Offering numerous examples, MDA/GD/0009 provides classifications of medical devices known as active, invasive and noninvasive,... Read More
A Chinese government program to buy pharmaceuticals and medical devices in bulk has been expanded to include a larger selection of devices, putting fierce competitive pressure on foreign medical device companies seeking to tap into the vast country’s market. First launched in 2018... Read More
Japan is way behind the US and EU for approving medical devices with AI. In September 2020, Japan introduced the IDATEN system (improvement design with approval for timely evaluation and notice) which was designed to quickly allow partial modifications of approvals for... Read More
Multinational pharmaceutical firms are taking advantage of fledgling low-cost commercial insurance initiatives in China to more readily access the country’s vast and rapidly growing market for their products—and to price them more competitively. Under strict eligibility rules on pharmaceuticals and medical... Read More