How To Define The Indication For Your Product In China?


To successfully obtain the NMPA approval, one must provide an indication for your product that the NMPA reviewer can accept. As a foreign product, the NMPA reviewer usually asks you to provide the same indication as your home country’s approval. For example, a device using US FDA as home country clearance/approval shall not submit indications using for European approval unless the US and EU indications are the same, or the EU indication is more accurate than the US indication. NMPA reviewer does not accept indication that is out of the scope of your home country approval.
Takeaway: Green Innovation Registration Pathway does not require home country approval for the products