China medical device market eRPS data error correction matters will be incorporated into the business scope on April 20, 2023. The Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) has issued (No.11-2023) the notice on April 19, 2023, for adjustments to the scope of business of the electronic declaration information system for medical device registrations.
Since its launch in 2019, the eRPS system has facilitated the registration of domestic Class III and imported Class II and III medical devices, registration changes, renewal of registration, notification of changes in instructions, and special review of innovative medical devices. The system has been running smoothly overall, and this new adjustment aims to further improve the online government service system for medical device registration.
The NMPA encourages eligible registration applicants to handle relevant business online through the eRPS system. The system’s expansion will allow applicants to correct errors in their medical device registration certificates using electronic versions of information. The Centre has created an electronic directory folder structure for reporting information on medical device registration certificate error correction, which will help guide registration applicants to prepare electronic versions of information.
Notice No. 11 of 2023 specifies the types of error correction declaration data in the Medical Device Registration Certificate Electronic Catalogue and what should be submitted. The data types include the Chapter Table of Contents, Application form, Certificate of Free Sale/Certificate of Listing, and Power of Attorney, among others. For example, the table of contents must include all titles and subtitles of this chapter, indicating the serial number of the table of contents, the title of the table of contents, the applicable conditions, the name of the uploaded document, the page number of the uploaded document, and the page number of each content in the table.
The application form should be filled in according to the requirements and uploaded with correct signature and seal. The Certificate of Free Sale/Certificate of Listing should include copies of the medical device registration certificate and its attachments. The Power of Attorney should clearly include the matters entrusted to handle error correction. If the power of attorney is newly issued, it should be the original and notarized. If the power of attorney containing the corresponding contents has been submitted at the time of application for registration, a copy of the power of attorney may be submitted.
In conclusion, the NMPA’s Notice No. 11 of 2023 is a significant step towards improving the online government service system for medical device registration in China. By expanding the eRPS system’s business scope, eligible registration applicants can easily correct errors in their medical device registration certificates using electronic versions of information. This will lead to greater efficiency and convenience for registration applicants while ensuring that medical devices are safe and effective.
Further information
Read the original CMDE announcement on the adjustments to the scope of business of the electronic declaration information system for medical device registrations.
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