In the context of medical device registration with the NMPA (National Medical Products Administration) in China, it is typically not a requirement to submit evidence of prior sales in the Chinese market. However, some specific circumstances or regulatory pathways may involve such documentation, particularly if:
Market Authorization Transfer: If you're applying for a transfer of market authorization for a device previously approved in China, you may need to provide proof of prior sales or a market history to support the application.
Clinical Trials or Data Requirements: If you are required to submit clinical trial data, the NMPA may ask for evidence of sales in other markets as part of the risk analysis, especially if the device is marketed in multiple countries. However, this is usually more about providing evidence of product performance and safety rather than directly proving sales in China.
Foreign Manufacturer’s Experience: In some cases, foreign manufacturers may be asked to submit evidence that their devices are in use or have been sold in other regulated markets (e.g., EU, US, Japan) to demonstrate that the product is already accepted in other major regulatory jurisdictions. This can sometimes serve as a proxy for establishing the device’s safety and efficacy.
In general, the NMPA focuses on ensuring that the product meets Chinese regulatory standards (including safety, efficacy, and quality) rather than focusing on sales history within the country.
For more detailed and specific requirements, especially if you're dealing with a particular class of medical device, you may want to consult the most recent NMPA guidance or work with a regulatory consultant who specializes in Chinese medical device registration.
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