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Guideline on Market Access for Medical Device in China is a report drafted by CIRS Group- Medical Device BU to help companies and individuals who would like to sell their medical devices to the People’s Republic of China and get their medical device products registered with NMPA. The guide describes key definitions, main regulations, authorities of the medical devices in China, and also the requirements of the whole life-cycle of medical devices including pre-registration preparatioin, registration process, testing/inspection, clinical evaluation, QMS and post-market management.
Adverse events (AE) refer to unfavorable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices. A serious adverse event (SAE) refers to a death or serious deterioration in health that occurs during a clinical trial, including fatal diseases or injuries, permanent defects in body structure or body function, requiring hospitalization or prolonged hospitalization, and the need to undergo Medical or surgical inte