Electronic Registration System in China

Electronic regulated product submission (eRPS) in China

Electronic regulated product submission in China

Overview of eRPS at NMPA


eRPS stands for electronic regulated product submission. In accordance to guidance “Non-In vitro Diagnostic Device Market Authorization Table of Contents” at International Medical Device Regulators Forum (IMDRF), NMPA published in 2021 guidelines for electronic submissions with requirements aligning with international table of content for all submission format. The new electronic submission format applies to:

 

  • Class II and III medical device in all types of registration (initial-, change- and extension registration)
  • Change notification in instruction for use
  • Change notification in NMPA certificate
  • Application of clinical trial of high risk medical device
  • Application of innovative medical device
  • Reissue of certificate of medical device
  • Cancellation of certificate of medical device


 

Backstage behind new requirements of eRPS


As of 01. 11. 2019 all submission dossiers have to be transferred through registered eRPS system to NMPA. No hard copy is required any more. China is second country after Canada to strengthe a clear table of content of submitted documents in electronic format. 


The Chinese entity or Chinese agent of overseas manufacturer should apply for "Certificate Authority" to log in eRPS. The eRPS system is independent from products. If Chinese agent take over this role, he can use one eRPS system to submit dossiers of diverse products and for different legal manufacturers.


Altogether there are 6 chapters instead of old 12 chapters in term of table of content. Below are the main documents matching each chapter listed. For overseas manufacturers it means re-structure of submission dossiers, as well the communication by means of new eRPS channel to receive and response acceptance- and additional request after  review by NMPA. It is also economically and ecologically a good example without submitting hard copy. From the view of authority, they have an electronic back up of documents of approved medical device to trace easily later on.


Documents needed for new table of content through eRPS:

  • CH.01 Administrative information

    • Application form
    • ISO 13485 certificate
    • Declaration of conformity as in EU (home country approval)
    • Declaration of conformity of standards and regulation

  • CH.02 Summary Materials

    • Device description
    • New: Worldwide notifiable incidents
    • New: Worldwide marketing history

  • CH.03 Non-clinical information

    • Risk management file
    • Product technical requirement
    • Type testing report
    • Software file
    • Pre-clinical study as biocompatibility report
    • Essential safety and effectiveness requirements
    • Shelf life and packaging verification


  • CH.04 Clinical research data

    • Clinical evaluation
    • Clinical study 

  • CH.05 Instructions for use and labels

    • All marketing materials
    • IFU
    • labels

  • CH.06 Quality management system

    • General production information
    • New: quality manual, quality objective and quality policy
    • New: resource procedure
    • New: Product realization procedure
    • New: Design and development procedure
    • New: Procurement procedure
    • New: Production and service control procedure
    • New: Monitoring and measuring procedure
    • New: Measurement, analysis and improvement procedure
    • New: QM system (personal, organ chart, layout plan of production site)
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