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Australia: TGA released guidance to clarify the regulatory obligations of sponsors and manufacturers with exempt medical devices - August/September 2024

Australia: TGA released guidance to clarify the regulatory obligations of sponsors and manufacturers with exempt medical devices - August/September 2024

  • 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

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China: New NMPA and NHC Guidelines Streamlining Temporary Importation of Urgently Needed Medical Devices in China's Clinical Settings  - August/September 2024

China: New NMPA and NHC Guidelines Streamlining Temporary Importation of Urgently Needed Medical Devices in China's Clinical Settings - August/September 2024

  • 2024-09-17 05:26:27

The National Medical Products Administration (NMPA) and National Health Commission (NHC) have issued guidelines for the temporary importation of urgently needed medical devices in clinical settings. The regulation streamlines import processes while ensuring compliance with safety standards, allowing medical institutions to quickly access essential, unregistered devices. It aligns with NMPA Orders No. 47 and 48, emphasizing patient safety and timely access to critical medical equipment.

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HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

  • 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

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