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SUBMISSION CHANGES IN CHINA: ToCs and the eRPS
Published: April 20, 2020
China NMPA (former CFDA) recently announced that the implementation of Electronic Regulated Product Submission system (e-RPS) will come into effect on June 24, 2019. The format and arrangement of content stipulated are now part of the regulatory requirements to file for NMPA submission.
The e-RPS system was initially proposed by IMDRF (International Medical Device Regulators Forum) work group in March 2012. China, as an IMDRF member and 2018 rotating presidency, agreed to adopt these documents, and adapt them to meet local regulatory requirements where appropriate.
Following the announcement, NMPA issued a series of notices, that further explain the adoption and implementation of the policies and concepts in IMDRF documents within the NMPA’s regulatory framework. These include Notice on Implementation of Electronic Submission System for Medical Device Registration (No. 46, 2019), Technical Guideline on Registration Material Requirements for Electronic Submission System trial version (No. 29, 2019), Notice on Processing of Medical Device Registration Electronic Declaration Information System (No. 4, 2019), and Notice on the structure of folders of RPS ToC (No. 5, 2019).
Changes to NMPA registration requirements
Old System: device registration files had to follow requirements set in Order 43 (2014).
eRPS System: registrants must follow technical guidelines for electronic submissions found in Order 29 (2019).
Dossier submissions to NMPA
Old System: 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.
eRPS System: 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).
Old System: supplementary notices were sent to NMPA acceptance service center directors for double-checking after initial simple reviews.
eRPS System: all reviewers in a department will discuss supplementary opinions before sending supplementary notices to directors.
Old System: 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.
eRPS System: supplementary documents must be submitted electronically through the eRPS system. No additional supplementary information may be requested or submitted.