It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.
The US Food and Drug Administration has failed to meet yet another internal deadline for publishing a draft of its overhauled Quality System Regulation. The agency has been harmonizing its QSR with international quality systems standard ISO 13485 for nearly three years now.
The FDA’s February 2021 target for releasing the draft, set by the agency in December, is the fifth...
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MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.
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European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.
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