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Medical Device Consulting Services for Hong Kong
Hong Kong is a Special Administrative Region of China but has its own legal and regulatory system. Hong Kong's Medical Device Control Office (MDCO) - not the China Food and Drug Administration (CFDA) - oversees medical device regulations in Hong Kong. Although no mandatory regulations are currently in place for importation, distribution, or sale of medical devices in Hong Kong, new rules are anticipated. Medium and high risk devices may be registered voluntarily; this is highly recommended for manufacturers intending to sell to private and government hospitals. Emergo’s team in Hong Kong has the expertise to help you navigate the developing regulatory system.