China NMPA (CFDA) has implemented electronic Regulated Product Submission (eRPS) system since June 24, 2019, while the regulations for E-submission are still evolving. Below are some new requirements for it.
NMPA 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 ePRS 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.
Do you have questions on applying the Certificate Authority (CA), structuring of Table of Contents and formatting of Chinese / English E-documents? Have you noticed the difference between China's E-submission and those from EU and U.S? Please leave your comments here or email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------