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Medical Devices – USA, Europe, Asia and ROW Regulatory News – Apr 2024

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USA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog



EUROPE



CHINA



FINLAND



GERMANY

  • Reports of serious incidents in accordance with Article 87 MDR by manufacturers (for medical devices excluding in-vitro diagnostics)
  • Reports of serious incidents in accordance with Article 82 of Regulation (EU) 2017/746 – IVDR (for in-vitro diagnostics)


HONG KONG



HUNGARY

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

From 31 January 2025 onwards sponsors are requested to transition to the legal framework of the CTR the ongoing clinical trials that are currently under the regime of the Clinical Trials Directive (CTD) and expected to be ongoing after 30 January 2025.



PORTUGAL



PHILIPPINES



SAUDI ARABIA

Update: Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use

The updates in this version are as follows:

  • Create a new email to receive application Hajj@sfda.gov.sa
  • Change the email to Hajj@sfda.gov.sa
  • Applications will be received via External Hajj Unified System of the Ministry of Hajj.


SOUTH KOREA



SPAIN



SRILANKA



SWITZERLAND

Information sheet Medical Device Software



THAILAND



UNITED KINGDOM

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