Digital CA certification adjustment notice of electronic declaration information system for medical device registration

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Digital CA certification adjustment notice of electronic declaration information system for medical device registration

Aozida medical technology service release date:2020-04-08

Notice on adjusting the handling method of digital authentication (CA) certificate business of electronic declaration information system for medical device registration (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 following adjustments shall be made to the handling method of applying for digital certification (CA) certificate of information system:
1、 The applicant submits the CA certificate application normally according to the CA application operation process described in the notice on matters related to the application for digital authentication (CA) certificate of medical device registration electronic declaration information system.
2、 From now on to the date of the epidemic situation, after the application has been reviewed, the on-site audit and Ca distribution will be changed from on-site processing to mail processing. The specific way is to log in to the "medical device registration enterprise service platform" after the applicant receives the SMS approved by the application data( https://erps.cmde.org.cn , hereinafter referred to as the service platform), the only date specified by the reservation platform (this date is only for appointment use, and has nothing to do with the release date), prepare the paper certification documents according to the page prompt (see Annex 1 for details), and send them within two weeks Send it to the business hall of our center by EMS or SF express, and mark "Ca handling information" in the mail message. After receiving the paper certification documents, our center conducts background audit on them. After the audit is passed, the corresponding CA certificate media will be mailed to the address provided by the applicant. The applicant shall ensure that the receiving address, the recipient (CA certificate administrator himself) and other information provided are true and valid (see Annex 2 for details).
3、 After receiving the CA certificate media (USB key), the applicant should first click "CA certificate application environment" in the upper right corner of the login page of the service platform, insert the CA certificate media into the computer after installation, and select the "digital certificate" login method to 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's information, input the CA certificate administrator's SMS verification code, and then 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 e-mail, and wait for our center to deal with it.
5、 The way of Ca information change or replacement that needs to be handled on site is the same as above. In case of application for CA information change, the change person shall mail the original CA certificate media together with paper documents to our center.
Mailing address: Building 1, yard 50, Fengqi Road, Haidian District, Beijing
Attn: business hall of Audit Center
Tel: 010-86452929
Post code: 100081
E-mail: qmdivision@cmde.org.cn
The time for CA certificate business to resume normal arrangement shall be notified separately according to the national requirements for epidemic prevention and control.
Notice is hereby given.

Medical device technical evaluation center 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 drugs and 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) of the State Drug Administration will be put into trial operation in the near future. According to the law of the people's Republic of China on network security, the law of the people's Republic of China on electronic signature and other relevant regulations of e-government, in order to ensure the security of user's account and carry out electronic signature on electronic documents, medical device manufacturers need to adopt the digital authentication (certificate) supporting the ERPs system Authority (CA) certificate was registered in the electronic declaration information system of medical devices. We hereby inform you of the following matters concerning the application and use of CA certificate:

  一、自2019年5月10日起,醫療器械申請人/注冊人可以通過eRPS系統開始申領CA證書。CA證書申領人/持有人應是境內第三類醫療器械申請人/注冊人或者進口醫療器械生產企業的代理人。每個企業僅限申領一個具有簽章功能的CA證書。
  二、申領人進入醫療器械注冊企業服務平臺(平臺網址:http://erps.cmde.org.cn)進行用戶注冊后,即可使用賬號密碼登錄,進入“CA證書申領”模塊。關于CA申領操作流程和管理有關事宜的說明詳見附件。
  三、使用CA證書的單位應當建立制度,明確CA證書的實際保管人(CA證書管理員)、使用權限、用途、登記等內容。CA使用單位應當妥善保管我中心發放的數字證書、私鑰及保護密碼,避免泄漏、轉讓、轉借他人。如因用戶保管不善導致CA遭盜用、冒用、偽造或者篡改以及由此帶來的不良后果,由用戶自行承擔相關法律責任。
  四、器審中心建立了電子申報系統運行服務保障小組,對企業在使用電子申報系統及CA證書認證過程中出現的問題提供有效的幫助。申請人/注冊人可通過熱線電話、在線QQ交流群獲得遠程幫助,也可在器審中心業務大廳獲得現場指導。
Address: Building 1, yard 50, Fengqi Road, Haidian District, Beijing
Post code: 100081
Technical support: 13391835251
Feedback: 010-86452952, 010-86452740
QQ communication group: 961097116
Medical device technical evaluation center of State Drug Administration
May 7, 2019
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