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The National Medical Products Administration (formerly China Food and Drug Administration, CFDA for short) certifies and approves all medical devices entering into Chinese market. All medical devices, in-vitro diagnostic reagents, and drugs must be filed or registered by the Chinese regulator—the National Medical Products Administration (NMPA).
The local representative is known as the NMPA Legal Agent. The NMPA Legal Agent has an increasingly important role to play as the regulatory emphasis evolves from point-in-time registration focus to whole of lifecycle supervision.
Product technical requirements are one of the most important documents in medical device registration and are implemented throughout the entire life cycle of medical devices.
On August 31, 2018, the official website of the National Medical Products Administration issued the "Administrative Measures for Monitoring and Re-evaluation of Medical Device Adverse Events" (State Administration for Market Regulation Order No. 1) (hereinafter referred to as the "Measures"). The Measures put forward a series of new work requirements for medical device registrants, including writing regular risk assessment reports for post-market medical devices.
Clinical trial of medical device refers to the process of confirming the safety and effectiveness of medical devices (including in vitro diagnostic reagents) to be applied for registration under normal use conditions in qualified medical device clinical trial institutions.
Food for Special Medical Purposes (hereinafter referred to as FSMP) refer to formula foods specially processed and formulated to meet the special needs of nutrients or meals for people with dietary restrictions, digestion and absorption disorders, metabolic disorders or specific disease states.
