Ann: Company Update, page-152

NMPA (CFDA) changes still being implemented and one can only imagine how much back and forth there must be to meet guidelines / approvals with the ever changing updates to the approval process, never mind having our lead rep suddenly pass away in the process.

NMPA (CFDA) issued “Notice on Requirements for Medical Device Electronic Submission” on July 10. It lists three requirements which are to be implemented on August 1, 2019.When registering imported device, only the probative documents, declaration of conformity and labels shall contain the notarized documents issued by the notary body at the place where the applicant is located;Considering the folder structure of Regulated Product Submission Table of Contents (RPS ToC), the page number of the registration materials under the heading of any level can be compiled separately;The Technical Requirements in the electronic registration application materials should be contained in a single copy.The electronic Regulated Product Submission (eRPS) has taken into effect on June 24, 2019. The system affects domestic class III, imported class III and imported class II medical devices and IVDs. The scope includes initial registration, supplement, renewal, modification, type test request, high-risk Class III devices’ clinical trial request, modification of Instruction for Use (IFU), Innovation Approval application, etc.




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