An alternative way for NMPA registration if device does not have FDA approval

Hi Everyone,

Is there a alternative route to get the NMPA registration when the company the product does not have the FDA approval. The device is manufactured in the USA.

Thanks

Nope. When you apply to NMPA for an imported license, one of the requirements is regulatory approval in country of origin, i.e. approval from FDA.

Shimon

I echo what has been said above. Most of the applicable regulatory requirements for market applications require market approval / clearance in the home country of the manufacturer. Generally speaking if the company is a US company and wants to commercialize abroad, in most cases, but not necessarily all, home-country clearance / approval of the product is required. There are a few exceptions. You may want to look into the Country of Chile, and some of the Caribbean nations which don't all require home-country approvals.

What if the company manufactures the device in the USA, not for sale in the US, and it is an export-only product? Can we get the Certificate of Foreign Government (CFG), section 801(e)(1) and apply for NMPA registration ?