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The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.
The US FDA announced that it has launched a pilot program designed to help medical device premarket reviews become more efficient.
The UK’s MHRA invited public comment regarding its proposed fee increases.
The US FDA released a list of guidances it plans to issue over its 2023 fiscal year.
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
Health Canada finalized guidance on clinical evidence requirements for medical devices.
Health Canada reminded manufacturers of EHR-based medical devices to obtain a medical device license and/or establishment license.
Malaysia’s MDA published draft guidance that provides a notification process for manufacturers of custom-made medical products when seeking Malaysian market access.
Europe’s Medical Device Coordination Group (MDCG) has issued guidance on the responsibilities of authorized representatives.
The US FDA has issued draft guidance on select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility.
The FDA released its 2023 medical device user fees and some have increased sharply since last year.
Taiwan’s MOHW has issued a draft revision of UDI requirements and a draft amendment of the charge standards of administrative fees for medical devices.
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