Jul 8, 2019

Emergo by UL has learned additional details regarding the China National Medical Product Administration’s (NMPA) new electronic medical device registration management (eRPS) system.

Following NMPA’s implementation of the eRPS system on June 24, Emergo by UL consultants attended eRPS training in Beijing. Information learned during the training includes:

  • NMPA’s ePRS system is based on International Medical Device Regulators Forum (IMDRF) guidelines, and its requirements are harmonized with those of other regulators’ electronic registration systems.
  • Registration content requirements set by Order 43 (2014) (link in Chinese) have not changed, but registration file format and order requirements are different under eRPS.
  • Eventually, NMPA will publish new medical device and IVD registration file requirements that will replace Order 43 (2014) as well as Order 44 (2014) (link in Chinese).
  • NMPA plans to cancel across-the-board notarization requirements for foreign registration documents; instead, notarization requirements will be limited to documents such as home country approval certificates and authorizations for Legal Agents.
  • Chinese regulators’ plans to roll out a Device Master File registration filing platform are on track.

eRPS and changes to NMPA registration requirements

Changes related to specific steps in the Chinese medical device registration process were covered during eRPS training:

Document preparation

  • Previously, device registration files had to follow requirements set in Order 43 (2014).
  • Now, registrants must follow technical guidelines for electronic submissions found in Order 29 (2019) (link in Chinese).

Dossier submissions to NMPA

  • Prior to eRPS implementation, registrants were required to submit hard copies of their dossiers to NMPA administrative acceptance service centers via mail or in person; dossiers underwent “simple review” by acceptance service center officers upon receipt.
  • Following the launch of eRPS, NMPA no longer requires hard copies of dossiers in favor of electronic copies. Registrants may still submit hard copies of their dossiers under existing submission processes and formats until November 1, when use of eRPS becomes mandatory. In such cases applicants must also include electronic copies via USB storage devices. Furthermore, dossiers now undergo “strict review” at the Center for Medical Device Evaluation (CMDE).

Technical evaluations

  • Previously, supplementary notices were sent to NMPA acceptance service center directors for double-checking after initial simple reviews.
  • Under eRPS, all reviewers in a department will discuss supplementary opinions before sending supplementary notices to directors.

Supplementary documentation

  • Previous requirements entailed preparation and submission of supplementary documents in hard copy to CMDE in-person or through the mail. CMDE reviewers had the option to request additional supplementary data.
  • Now, supplementary documents must be submitted electronically through the eRPS system. No additional supplementary information may be requested or submitted.

Emergo by UL will provide additional details on China’s new eRPS system as they become available.

Learn more about China’s medical device regulatory system at Emergo by UL:

  • China NMPA medical device registration consulting
  • Assessment support for Chinese medical device clinical and testing requirements
  • Regulatory process chart: China NMPA medical device registration and approval