In May 2019, the issuance of digital certificates (“CA certificates”) for use with the electronic registration platform system (eRPS) was launched. To better align with current CA certificate management needs, optimize CA certificate-related workflows, and facilitate medical device registration applicants in applying for, changing information, renewing, and reissuing CA certificates, the following adjustments have been made:

1. Effective April 15, 2024, the management of CA certificate is transferred to the CA certificate issuing authority (Beijing Digital Authentication Co., Ltd.). Medical device registration applicants are required to handle CA certificate applications, changes to information, renewals, and reissuances through the platform of the CA certificate issuing authority and bear the associated costs.
2. Cases under the following criteria will stick to the original procedure:

• Applicants who submitted CA certificate applications in eRPS before April 15, 2024
• CA certificates that are due for renewal before the expiration date on April 15, 2024.

 

Reference:

Notice on the Adjustment of Digital Certificate Management for the Electronic Registration Platform System for Medical Device Registration (eRPS) (No. 16 of 2024)