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• 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.