According to the request of General Office of the Communist Party of China and General Office of the State Council, National Medical Product Administration (NMPA) has begun the trial operation of electronic regulated product submission (eRPS) with the aim to protect the security of user account. Starting from May 10, 2019, applicant/registrant of Starting from May 10, 2019, applicant/registrant of Class III domestic product or China agent of the imported medical device manufacturer can apply for CA through the enterprise service platform for medical device registration (Link: http://erps.cmde.org.cn). Every enterprise is limited to possess one CA certificate.
For enterprise who are interested in understanding the requirements and the necessary documents for the CA application, please reach us at global@osmundacn.com and we will provide relevant information and support you throughout the process.
The workflow for initial application of CA is depicted as following:
Useful link: http://erps.cmde.org.cn
Original article: https://www.cmde.org.cn/CL0004/19109.html