• Medical Devices – Regulatory Updates – January Volume 1

    6 January 2021 Regulatory Updates
    Europe | US FDA | CANADA (HC) | Australia (TGA) | China (CMDE) | India (CDSCO) EUROPE 1. ...
  • Medical Devices – Regulatory Updates December Volume 1

    3 December 2020 Regulatory Updates
    Europe | Australia (TGA) | Philippines (FDA) | China (CMDE) EUROPE 1. Converting ...
  • EU MDR Implementation Extension – helps in Compliance Planning

    26 November 2020 EU MDR
    As the extended transition deadline 26 May 2021 is approaching, we should be ready for ensuring ...
  • Medical Devices – Regulatory Updates – November Volume 2

    20 November 2020 Regulatory Updates
    Europe | US FDA | Australia (TGA) | Malaysia (MDA) | Japan (PMDA) EUROPE 1.MDCG releases ...
  • PMS Planning and Challenges under EU MDR

    15 October 2020 EU MDR
    While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device ...
  • Device Label Externalizing or Outsourcing

    7 October 2020 Labeling
    If you are single product Device Company or single country multi-product company or a company ...
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