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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Eight innovative technologies selected under IDAP pilot phase

MHRA launched Innovative Devices Access Pathway (IDAP) back in September 2023 to help streamline applications for innovative medical technologies. Today, MHRA have announced that eight innovative medical device technologies are selected for the IDAP. The eight selected innovative devices are: Blood test for Alzheimer’s disease: Roche Diagnostics Ltd has developed an Amyloid Plasma Panel which could help clinicians decide if…
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February 14, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Health Canada: Draft guidance on how to interpret ‘significant change’ of a medical device

This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand…
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February 14, 2024