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Global Registration

Global Registration 

  • Canada - MDEL, MDL

  • Israel - AMAR Registration

  • Brazil - INMETRO, ANVISA

  • Japan - MHLW, PMDA, Categories: Todokede, Ninsho, Shonin

  • China - CFDA (now NMPA)

  • Other LATAM countries (Argentina, Mexico, Pero etc); other APAC countries (S Korea, Singapore, Vietnam etc) 

  • Australia - TGA

  • Middle East countries 

  • Define the specific in-country' regulatory requirements including labeling & GUI language.

  • Working directly with local authorities, distributors or Marketing Authorization Holder to register the product.

  • Preparation of Summary Technical Documentation (STED).

  • Design the clinical study when required to support local registration.

Global Registration

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