Yes, when applying for NMPA (National Medical Products Administration) registration in China, you may need to provide evidence of sales or market presence in China as part of the registration process. This is particularly relevant for certain types of medical devices, especially if they have been previously marketed in other countries.
Evidence of sales can help demonstrate the product's safety, effectiveness, and acceptance in the market. It may include:
- Sales Data: Documentation showing sales volume, revenue, and market penetration.
- User Feedback: Reports or testimonials from healthcare professionals or patients using the product.
- Clinical Evidence: Data from clinical trials conducted within China or internationally that supports the product's performance and safety.
The specific requirements can vary based on the device classification and its intended use, so it's important to consult the latest NMPA guidelines or work with a regulatory expert familiar with the Chinese market.
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