• Medical Devices USA/Europe Regulatory Updates round up, June 2021

    7 July 2021 Regulatory Updates
    EUROPE | US FDA | CANADA (HC) EUROPE 1. Questions and answers on obligations and ...
  • Medical Devices – Regulatory Updates – Asia Round Up – Jun 2021

    5 July 2021 Regulatory Updates
    Singapore (HSA) | Malaysia (MDA) | JAPAN (PMDA) | Kazakhstan (NDDA) | AUSTRALIA (TGA) | ...
  • Devices: Real world data for premarket and post-market usage

    28 June 2021 RWD/RWE
    Real-world data (RWD) can be collected from a diverse array of sources, such as electronic health ...
  • TGA’s Reclassification of Medical devices around the corner. Ready?

    24 June 2021 EU MDR
    The New Reclassification system for medical devices is round the corner to its effective date (25 ...
  • MHRA: Registration requirements for IVDs

    10 June 2021 IVDR
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance on ...
  • Revised Chinese Medical Device Regulations by NMPA

    9 June 2021 EU MDR
    On 18Mar2021, from NMPA published the final version of "Regulations on the Supervision and ...
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