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Global Registration
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Canada - MDEL, MDL
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Israel - AMAR Registration
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Brazil - INMETRO, ANVISA
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Japan - MHLW, PMDA, Categories: Todokede, Ninsho, Shonin
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China - CFDA (now NMPA)
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Other LATAM countries (Argentina, Mexico, Pero etc); other APAC countries (S Korea, Singapore, Vietnam etc)
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Australia - TGA
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Middle East countries
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Define the specific in-country' regulatory requirements including labeling & GUI language.
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Working directly with local authorities, distributors or Marketing Authorization Holder to register the product.
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Preparation of Summary Technical Documentation (STED).
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Design the clinical study when required to support local registration.
Global Registration
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