We are a Swiss-based manufacturer of a single-use, sterile medical device for which we hold a Chinese registration certificate for Class III imported medical devices.
For various reasons, we would like now to ship in bulk (the import license includes bulk packaging) and do the final packaging configuration and labeling in China. We would like to do this in mainland China (not in a bonded zone).
Our current understanding is that finished products that have been imported in China under an import license cannot be repackaged in China. Semi-finished products can be imported as raw materials and manufactured to final products in China. These products can be registered with a domestic license. However, for this to be possible, the main manufacturing process must be done in China. Final packaging does not qualify as main manufacturing process and therefore this pathway does not seem possible in our case. It seems that we have come to a dead-end.
I would be grateful for any suggestions of regulatory options allowing us to import bulk product, perform final packaging in China and sell it locally.
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Andrea Sparti
Head of Regulatory Affairs
Ypsomed
Switzerland
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