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The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
The new assay makes use of “micro-neutralization” technology, which monitors antibodies’ ability to restrain viruses from reproducing themselves in animal cells. Read More
Companies will need to report within 48 hours from discovery if a medical device sold in Malaysia presents a serious threat to the public health according to new requirements released by Malaysia’s Medical Device Authority. Read More
A new study of the four biggest makers of pacemaker systems found thousands of software vulnerabilities, highlighting an industry-wide problem with software security updates. Read More
Both houses of Australia’s Parliament passed a new law to amend the Therapeutic Goods Act 1989 to enable certain variations that do not impact quality, safety or efficacy to be made by notification to the Therapeutic Goods Administration. Read More
How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans? Read More
As of June 1, South Africa has its first regulatory system for medical devices and in vitro diagnostics, which will include new quality management requirements. Read More
Following a spate of superbug outbreaks and deaths from contaminated duodenoscopes and similar devices, the FDA will soon have tougher validation requirements for certain new devices. Read More
In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More
The Dutch medical device authority has reached a voluntary agreement with industry on the use of UDI codes for medical devices, using FDA’s UDI system as a template. Read More