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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
The proposed amendment to the country’s Food & Drugs Act would require full incident reports to Health Canada from any hospital that provides acute care products. Read More
The Dutch Minister of Health signed the agreement in late June, in collaboration with healthcare providers and device distributors and manufacturers. Read More