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SFDA’s Project Draft Guidance of Import / Re-export Requirments for Medical Imaging Materials.

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  • SFDA’s Project Draft Guidance of Import / Re-export Requirments for Medical Imaging Materials.

SFDA has recently published the Draft Guidance of Import / Re-export Requirements for Medical Imaging Materials; Click here to read the official document.

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Highlights from this Document

This guidance is intended to clarify SFDA Requirments of importation and re-exportation of medical imaging materials.

This guidance is applicable to:

  • Imaging materials used in medical applications (diagnostic/therapeutic).
  • Importers and exporters of these materials and health service providers.

Page 4 in the DRAFT guidance states all the requirements needed to obtain approval for import or re-export of imaging materials used in medical applications.

Page 6 and 7 in this DRAFT guidance states all the required documents that is needed to obtain approval for import or re-export if imaging materials used in medical applications.

Application form for permission to import and re-export electronic medical imaging materials in the unified system.

Disclosure form of Radioactive Materials, Narcotic Substance or Chemicals subject to public security control.

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