1. Routes of Submission
Online: Applicants/registrant may submit the electronic dossiers that meet the requirements of CMDE (Note: the filing of Class I Imported Medical Devices, Application for Re-issuance, Error Correction, Initiative Cancellation,Initiative Revocation of Registration Application and Medical Device Registration Designated Tests are not included in the business scope of eRPS system for the time being).
Offline: The paper dossiers can be submitted to the Administrative Service Hall either by post or on site.
2. When and Where
(1). Online
Upload and submit can be done anytime and anywhere through eRPS system.
(2). Offline
When: Working day(9:00am-11:30am;13:00pm-16:00pm).
Service Hall closed on Wednesday and Friday afternoons.
Where: Administrative Service Hall (1/F, Unit 3, Dacheng Plaza, No.28 Xuanwumen West Street, Xicheng District, Beijing).
3. Preparation
(1). Online
Electronic declaration materials in the form of RPS ToC.
Obtain a Certificate Authority(CA) in conjunction with the eRPS systemin advance.
(2). Offline
Paper registration dossiers and a USB flash disk containing RPS ToC form registration dossiers.
The signed “paper version and electronic version of the document conformance statement” (one copy of the paper version and one electronic scan).
Power of attorney from the Applicant (consistent to the seal affixed on the application form) to the agent and for the matters to be handled.
The original and photocopy of identification certificate of the applicant or its agent.
4. Procedures
(1). Online
Application for CA: enter the Enterprise Service Platform of Medical Device Registrationfor user registration and enter the module of “CA certificate application”.
Online submission: it can be done through the website or the eRPS client.
(2). Offline
Applicant/ registrant can log in the Online Reservation System for reservation from 7:00am to 23:00pm every day. Besides, applicant/registrant may also take a waiting list number from the Administrative Service Hall instead of reservation online.
On-site handling:Applicant/registrant wait for their number to be called.Priority is given to those with online reservation.
5. Signing, acceptance and payment
Signing and receiving: for the application for registration of medical devices submitted offline (including on-site and post), the staff will upload the application dossiers on USB flash disk to eRPS system.After the electronic dossiers submitted online or offline are successfully uploaded, they will be automatically transferred to the signature link of the system, and the successful receipt will be informed to the applicant/registrant by SMS.
Acceptance: the center will conducts a review of the application dossiers to decide whether or not to accept the application or to issue a deficiency letter.If the application dossiers meet the requirements, the center will officially accept the application and issue “Notice of Acceptance” and “Bill of Payment”. If not, the dossiers willbe returned together with a “Deficiency Letter” or “Notice of Rejection”.
By default, the center will send the administrative acceptance documents to the applicant/registrant by mail, but at the same time, if the registration application is submitted online, the applicant/registrant can check the electronic documents by logging in the medical device registration enterprise service platform with CA. For those who submit offline and didn’t choose to mail the registration application, they can go to the Service Hall to get the administrative acceptance documents.
Payment: Applicant/registrant shall pay the service fee timely upon receiving the “Bill of Payment”.
