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ARQon (Asia Regulatory & Quality Consultancy) assist medical device and drug companies in product registration, in-country license holding, product technical / clinical evaluation documentation and regulatory / quality / distribution management. Countries expertise:
ASIA – Australia TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN – Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS – Brazil ANVISA, Health Canada, Colombia INVIMA, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE – Notified Bodies Approval
MIDDLE EAST – Emirates MOH, Saudi Arabia FDA Approvals