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Japan’s Pharmaceuticals and Medical Devices Agency has been ramping up its regulatory training activities with overseas regulators, and it inviting international regulators to a medical device seminar in Tokyo, Nov. 6-10. Read More
The FDA added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards. The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities. Read More
Establishments that have applied for registration but have yet to submit complete information should complete the application on or before Oct. 31, 2017, the agency said. Read More
Australia’s Therapeutic Goods Administration is urging devicemakers to meet with the agency before submitting conformity assessment applications. Read More
Sweden’s Medical Products Agency issued guidance on the new EU procedures for appointing a notified body that will go into effect on Nov. 26. The agency promised to issue further updates when there’s “more clarity around notified bodies in the EU.” Read More
China’s high court called for severe criminal punishments for deliberately falsifying medical device clinical trial reports and other related documents,… Read More
Regulatory authorities in Australia, Brazil, Canada, Japan and the United States are concluding a three-year MDSAP pilot before the formal program gets underway. Read More