Hamburg, 20.06.2019, Yue Li
On 31st May 2019, the NMPA (National Medical Product Administration) issued the notice for implementation of the electronic submission, 2019 No. 46 and the technical guideline for electronic submission of medical device registration application as a pilot project.
As of 24th June 2019, the applicants for medical device registration, change registration, clinical trial approval of high-risk class III devices, modification of instructions for use of medical device and innovative medical device application can use the eRPS system for document submission. The main goals for adopting the electronic submission are to reduce the reporting burden of the registrant, improve the quality of the registration materials and optimize the review process. As a member of IMDRF, China is trying to modernize its regulatory mechanism. The detailed requirements on electronic submission are set in the technical guideline. Even though the traditional submission method is still available the NMPA encourages the applicants to conduct electronic submissions. The transition period to the electronic submission is still unclear, nevertheless, as of 1st November 2019, the structure of the paper form submission should meet the structure of electronic submission. In 2019, there are already two public service trainings for electronic submission held and over 800 medical device manufacturers have been trained. More relevant trainings and guidance will be organized in a targeted manner to ensure the transition from paper materials to digitalization.
As a first step for the electronic submission, applicants need a CA (Certificate Authority), which should be applied for online (http://erps.cmde.org.cn) and assigned to the applicant in form of a USB key. The holder of the CA for International manufacturers are usually the authorized representative in China.
For the submission, the applicants should follow the directory hierarchy and relevant requirements. The eRPS system adopted the RPS ToC (regulated product submission table of contents) as suggested by the IMDRF with slight modifications to comply with the China specific regulatory requirements. The differences are mainly reflected in Chapter I, regional regulatory management information and Chapter VI, Quality Management System. The applicability submission of the RPS ToC file includes three categories: mandatory file (R), submission when applicable (CR), and no submission (NR). The applicants should justify whether the CR catalogue is applicable or not.
In order to ensure smooth implementation of the eRPS, CMDE (Center for medical device evaluation) now opens the consultation service regarding the electronic submission and provides training videos on their website. If you have decided to manage your medical device registration in China more efficiently with higher transparency, it is the right time to get familiar with eRPS.