Notice on digital CA certification adjustment of medical device

Aozida medical technology service release date: April 8, 2020

Circular on adjusting the handling method of digital certification (CA) certificate business of medical device registration electronic declaration information system (No. 12, 2020)

Issued on April 7, 2020

       Novel coronavirus infection is a comprehensive implementation of joint prevention and control measures to reduce the flow of people, to prevent the spread of the spread of the epidemic channels, protect the lives of the people, and to ensure the smooth progress of the registration of medical devices to the greatest extent, and to support the orderly resumption of medical equipment manufacturing enterprises. The application information system digital certification (CA) certificate business processing method shall be adjusted as follows: 
       1、 The applicant shall normally submit the application for CA certificate according to the operation process of Ca application described in the notice on application for digital certification (CA) certificate of medical device registration electronic declaration information system. 
       2、 From now on to the date of the termination of the epidemic situation, after the application has been reviewed and approved, the on-site audit and Ca issuance shall be adjusted from the on-site handling to the mail handling. The specific method is that after the applicant receives the short message of the application materials, he / she logs in to the "medical device registration enterprise service platform" (https://erps.cmde.org.cn, hereinafter referred to as the service platform), the only date specified by the appointment platform (the date is only for appointment use, not related to the date of issuance), prepares the paper supporting documents according to the page prompts (see Annex 1 for details), and within two weeks Send it to the business hall of our center by EMS or SF express, and indicate "Ca handling information" in the postal information. After receiving the paper supporting documents, our center will conduct background audit on them, and mail the corresponding CA certificate media to the address provided by the applicant after passing the audit. The applicant shall ensure that the information such as the receiving address and the recipient (CA certificate administrator himself) provided by him is true and effective (see Annex 2 for details). 
       3、 After receiving the CA certificate media (USB key), the applicant shall first click download "CA certificate application environment" in the upper right corner of the service platform login page, insert the CA certificate media into the computer after installation, select the "digital certificate" login mode, and confirm whether the user name displayed on the service platform is the name of the enterprise. 
       4、 If the applicant confirms that the CA certificate information is correct, use the "certificate unlocking" function to complete the CA certificate administrator information, input the CA certificate administrator s SMS verification code, and set the CA login password; if the CA certificate information is wrong, the applicant needs to mail the CA certificate media back to our center in time, and explain the situation through email, to be processed by our center. 
       5、 The change or supplement of Ca information to be handled on site is the same as above. In case of application for CA information change, the changed person shall mail the original CA certificate media together with paper certificate documents to our center. 
Mailing address: No.1 building, No.50 yard, Qixiang Road, Haidian District, Beijing 
Attention: business hall of equipment audit center 
       Tel: 010-86452929 
       Post code: 100081 
       The time for the resumption of normal operation of CA certificate shall be notified according to the requirements of the state for epidemic prevention and control. 
       Notice is hereby given. 

Technical Evaluation Center for medical devices of State Drug Administration

April 7, 2020

Policy Review

       According to the requirements of the opinions on deepening the reform of the review and approval system and encouraging the innovation of medical devices (Ting Zi [2017] No. 42) issued by the general office of the CPC Central Committee and the general office of the State Council, the electronic declaration information system for medical device registration (ERPs system) of the State Drug Administration will be put into trial operation in the near future. In accordance with the network security law of the people s Republic of China, the electronic signature law of the people s Republic of China and other relevant provisions of e-government, in order to ensure the security of user accounts and electronic signature of electronic documents, medical device manufacturers need to adopt the digital certification (certificate) which is used in combination with the ERPs system The certificate of authority (CA) is registered in the electronic declaration information system of medical devices. We hereby inform you of the application and use of CA certificate as follows:

  1、 From May 10, 2019, medical device applicants / registrants can start to apply for CA certificate through the ERP system. The applicant / holder of CA certificate shall be the applicant / registrant of class III medical devices in China or the agent of the manufacturer of imported medical devices. Each enterprise can only apply for a CA certificate with signature function.

      2、 After entering the medical device registration enterprise service platform (website: http://erps.cmde.org.cn) for user registration, the applicant can log in with the account password to enter the "CA certificate application" module. Please refer to the appendix for the details of the operation process and management of Ca application.

      3、 The unit using CA certificate shall establish a system to clarify the actual custodian (CA certificate administrator), use authority, purpose, registration and other contents of CA certificate. CA users shall keep the digital certificate, private key and Protection Password issued by our center properly to avoid leakage, transfer and lending to others. If the CA is misappropriated, fraudulently used, forged or tampered due to the improper storage of the user, and the resulting adverse consequences, the user shall bear the relevant legal liabilities.

      4、 The equipment audit center has established the operation service guarantee group of the electronic declaration system, which provides effective help for the problems in the process of using the electronic declaration system and CA certificate certification. Applicants / registrants can get remote help through hotline and online QQ communication group, and can also get on-site guidance in the business hall of the equipment audit center.

      Address: No.1 building, No.50 yard, Qixiang Road, Haidian District, Beijing

      Post code: 100081

      Technical support: 13391835251

      Feedback: 010-86452952, 010-86452740

      QQ communication group: 961097116

Technical Evaluation Center for medical devices of State Drug Administration
May 7, 2019