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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926957/