Source: CFDA

Notice of the General Office of the State Food and Drug Administration on Enabling the Subsystem of Acceptance, Certification, Technical Evaluation and Administrative Approval of the Medical Device Registration Management Information System

Food and Drug Administration Machinery Management Letter [2015] No. 804

December 15, 2015

Food and Drug Administration of the review center, acceptance and reporting center, information center:

In order to do a good job in the informatization of medical device registration management and improve the supervision efficiency, the Food and Drug Administration has organized and developed the "Medical Device Registration Management Information System Acceptance and Certification, Technical Review, and Administrative Approval Subsystem" (hereinafter referred to as the review and approval subsystem). The relevant matters are hereby notified as follows:

1. The review and approval subsystem was officially launched on December 20, 2015, and is used to handle the registration, change registration, renewal registration, and cancellation of domestic third-class, imported second and third-class medical devices.

2. please accept and report center issued a notice to inform enterprises in the medical device registration application when using the system. Enterprises using the system to handle related business need to submit paper application materials at the same time. Relevant supervisors and corporate personnel can click on the "Medical Device Registration Management Information System" in the "Online Service" column of the Food and Drug Administration Home (http://www.cfda.gov.cn). Operating manuals and demonstration videos can be downloaded from the system.

All relevant units in the 3. should attach great importance to it, strengthen the training of operators and use management, and coordinate and cooperate to solve the problems in use in a timely manner. If you have any questions, please contact the medical device registration department of the food and drug administration, the information center or the technical support personnel of the software module in time.

Medical Device Registration Division: Zhang Hao
Contact number:(010)88331469

General Administration Information Center: Zhang Yue, Lu Ying
Contact number:(010)88330138,88330130

Software module technical support: Li Youxiang, Duan Shaojie, Wang Tao
Contact number:18910681032,18810208401,18611115033

Annex: Medical Device Administrative Licensing Information Management System Acceptance and Certification, Technical Review, Administrative Approval Subsystem Launch Instructions

General Office of the Food and Drug Administration

December 15, 2015

Attachments:

Medical device registration management information system acceptance and preparation, technical review, administrative approval subsystem start-up instructions

The subsystem of medical device registration management information system for acceptance, certificate preparation, technical review and administrative approval (hereinafter referred to as this system) is an information platform that supports the business management of the declaration, acceptance, technical review, administrative approval and certificate preparation of medical device registration-related matters of the Food and Drug Administration, the main functions include the whole business process, information inquiry and statistical analysis of the declaration of the registration of imported second, third and third types of domestic medical devices. The users of this system include: relevant leaders of the Food and Drug Administration, the Medical Device Registration Management Department and the Medical Device Technical Review Center, the Administrative Matters Acceptance Service and Complaint Reporting Center, the Information Center and related enterprises.

1. System Login

The login address of this system: http:// 125.35.24.156; Or from the "online service" column of the website of the food and drug administration, log in to the "medical device registration management information system".

2. User Registration

General Administration end: user accounts, passwords and permissions of the General Administration end are uniformly allocated and maintained by the system administrator. In order to ensure information security, please modify the login password in time after the permission is assigned.

Enterprise side: enterprises that use the system for the first time must complete the user name registration through the "user registration" function before they can submit the declaration online. Enterprises that have already used the filing subsystem of the medical device registration management information system for filing declaration do not need to register again, and can continue to log in with the original account number and password. It is recommended that "one enterprise, one account" be used to facilitate the unified management and maintenance of all registration and filing related matters.

If the user forgets the password when logging in, please click the "Forgot Password" function and enter the E-mail and user name filled in when the user registers to find it.

In order to ensure the normal use and safety of the system, please remember the user name and password, and do not disclose the user name and password to others.

3. registration certificate number initialization

Considering the continuity of the registration certificate number, before officially using the system, please contact the system management personnel at the general administration end in time and initialize the registration certificate number so as to effectively connect with the original business.

4. the connection between the old and new systems

After the system is put into use, new application items are submitted and declared online through the system.

In the original administrative licensing management information system (including enterprise-side medical devices and in vitro diagnostic reagent registration electronic reporting software), applications that have not yet been completed will continue to be completed in the original system.

5. System Online Help

If the user encounters operation problems, he can log in to the system, click the "system help" function button, download the user operation manual and demonstration video, and operate the system according to the operation manual.

6. user feedback

During the probation period, for any problems and opinions in the use of this system, the interface personnel of the Medical Device Registration Management Department, the Medical Device Technical Review Center, the Administrative Matters Acceptance Service and the Complaint Reporting Center of the General Administration are requested to collect opinions and give them back to the technical support personnel for processing. The enterprise side can feedback the opinions13366059951@163.comE-mail.

7. technical support personnel contact information

Subsystem of acceptance, certificate preparation and administrative examination and approval: Duan Shaojie18810208401

Li Youxiang18910681032

Technical review subsystem: Wang Tao18611115033

[This article is reproduced, and the company does not guarantee its accuracy, reliability, completeness, and is not responsible for its views.]