If a foreign medical device company does not have its own office in China and does not want to let their distributor register their product there, registration can be done by an independent third-party company (agent) located in China. In all three cases, the local Chinese entity will act as the local agent.
Updated Chinese regulations that went into effect in May put more onus on local agents in the country to handle registration, monitoring, administration, and distribution of medical devices. While in the past, the legal responsibility of local agents was limited, the new government restrictions mean a significant increase in obligations by Chinese local agents.
The new regulations put local Chinese companies (agents) who hold product registrations in charge of a broad universe of responsibilities associated with quality assurance, etc. Independent third-party agents, acting as liaisons between the medical device regulatory authorities and overseas medical device manufacturers, must assist with product registrations and approvals, report adverse events associated with the medical devices, and cooperate with investigations and product recalls. The new regulations make local agents jointly liable (to a certain extent) with their overseas partners for any product quality or service violations and shorten the time period in which safety problems must be reported. They also mandate the local agents analyze, monitor, and clarify product risks and, in the case of implantable medical devices, retain monitoring records permanently.