Intelligent Allocation of Evaluation on Medical Device Registration Achieves Initial Success

  • 2020-05-29

On June 24, 2019, the electronic Regulated Product Submission (eRPS) system for medical devices was officially launched. Application items for medical device registration, including product registration, changes in licensing items, renewal of registration, and clinical trial approval, can be submitted online through the eRPS system. With the implementation of electronic submission, the new evaluation system optimized and reconstructed by the Center for Medical Device Evaluation of NMPA (hereinafter referred to as the Center) has been put into operation during the same period. The new evaluation system takes the new evaluation process as the main line, implants the intelligent allocation procedure for evaluation items, organically integrates the design of a series of crucial system designs of evaluation and approval reform, such as the classification of simple evaluation items and complicated evaluation items, division of stages of clinically-oriented evaluation, evaluation of the principal, evaluation of project team and filing evaluation.

By April 30, 2020, the eRPS system had received a total of 22,773 applications for registration of various types, of which 19,640 applications were submitted online, accounting for 86% of the total submissions. The number of online submissions has maintained steady growth, basically realizing the transition from paper-based submission to electronic submission. Faced with such a huge amount of submissions, the eRPS system and the new evaluation system have withstood the test and operated steadily, and the registration items of various medical devices are basically in good circulation. The intelligent allocation procedure for evaluation items has played a key role in the whole process. The system, in accordance with the preset allocation rules, automatically assigns evaluation items to reviewers with corresponding evaluation qualifications through the intelligent allocation procedure, effectively improving the efficiency of evaluation and approval.

Center for Medical Device Evaluation of NMPA

For original text and document, please refer to original Chinese website