Regulatory Insights & Updates

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MDCG 2022-16 Guidance for Authorised Representatives (AR)
Medical Devices and IVDsOctober 27, 2025

MDCG 2022-16 Guidance for Authorised Representatives (AR)

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How to Appoint a Local Authorized Representative in South Korea?
Medical Devices and IVDsOctober 27, 2025

How to Appoint a Local Authorized Representative in South Korea?

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Field Safety Corrective Action (FSCA) – Swiss
Medical Devices and IVDsOctober 27, 2025

Field Safety Corrective Action (FSCA) – Swiss

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Corrective And Preventive Action (CAPA)
Medical Devices and IVDsOctober 27, 2025

Corrective And Preventive Action (CAPA)

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How Saudi Arabia Regulates Software as a Medical Device (SaMD)?
Medical Devices and IVDsOctober 27, 2025

How Saudi Arabia Regulates Software as a Medical Device (SaMD)?

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New MIR Form 7.3.1 Accepted by Swissmedic: Key Updates for Medical Device Manufacturers
Medical Devices and IVDsOctober 27, 2025

New MIR Form 7.3.1 Accepted by Swissmedic: Key Updates for Medical Device Manufacturers

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