NMPA Shortens Time for Supplemental Submissions

For medical device registration in China, after a dossier is reviewed by the CMDE, additional information is almost always requested during the supplemental submission phase. Requested information can include things like additional supporting documents, more technical information, corrections of translations, etc. In January 2020, due to Covid, the NMPA extended the supplemental phase by one year so companies had 2 years to reply to these requests. On February 20 this year, the NMPA reversed this policy and now is only offering a one-year supplemental submission period, similar to the situation before Covid. Thus, for supplementary requests before February 20, 2023, applicants will still have 2 years to respond. But, for supplementary requests after February 20, 2023, the time to respond will only be one year.