In China, combination products are defined as a single entity that consists of both drug and medical devices. If the medical device plays the leading role, it will be classified as a device-based combination product. Otherwise, it will be classified as a drug-based combination product. NMPA has issued a draft guideline for the registration review of Device-based combination products. It is also recommended to submit a request to NMPA to get the official classification for your combination product.
Takeaway: The drug part of the device-based combination product should be already approved in China.
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