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Australia’s Therapeutic Goods Administration has revised its guideline on how manufacturers should classify in vitro diagnostics based on risk. Read More
Ethics codes have been getting more attention this year in Europe and the Asia-Pacific region, with industry groups adopting new business practices standards in the medical device sector. Read More
The Indian Pharmacopoeia Commission has released a proposed template for manufacturers or medical personnel to report adverse events involving medical devices. Read More
Singapore’s Health Sciences Authority has updated its guidance on how manufacturers should notify the agency of modifications to registered medical devices. Read More
Calling it a first for Japan, Cyberdyne has revealed that the country’s Ministry of Health, Labour and Welfare has approved the HAL for medical use, a robotic therapeutic device to improve patients’ walking function. Read More
AdvaMed has signed a strategic cooperation agreement with the government of Xining municipality in Qinghai province in China, in a deal designed to encourage scientific research, cooperation and exchanges. Read More
There is a big market in China for medical technology, such as orthopedic implants and spine devices, particularly as the population ages. Still, many of the multinational corporations have a corner on the premium market in more cosmopolitan areas over local rivals. Read More
For those manufacturers and other stakeholders wanting more information in English from Japan’s Pharmaceuticals and Medical Devices Agency, your wait may soon be over. Read More
The China Food and Drug Administration has issued four guidelines that give additional information for devicemakers awaiting good manufacturing practices inspections. Read More