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Special Review and Approval Procedure for Innovative Medical Devices (interim)

Article 1 

In order to ensure the safety of medical devices,  to encourage research and innovation in medical devices effectively, promote the popularization and application of new technologies, and promote the development of the medical equipment industry, formulated according to “Regulations for the Supervision and Administration of Medical Devices”, “Medical Devices Registration Administration Method” and other laws and regulations.

Article 2

CFDA administrative department will start the review and approval process according to this procedure for those medical devices which meet all followingrequirements.

1. The applicant, through his/her technological innovation activities, possess a core technology invention patent of the product by Chinese law, orpossess invention patents or the right to use by transferring; or core technology patent is published by the Patent Administration of the State Council.
2. The main mechanism of the products is initiated in china, and the performance or safety of the products has been greatly improved compared to similar ones. The technology of the products is in the international advanced level, and has significant clinical application value.
3. The applicant has completed preliminary research and has the basic product sample, all research work real and controlled, research data integratedand traceable.

Article 3

FDA at all levels and relevant technical institutions, according to their respective duties and requirements of the process, shall give priority to handle cases of innovative medical device under principles of “early intervention, individually assigned responsibility, scientifically approval procedure”, and the premise of “no lowered standard, no compromised procedure”, and stay close communication with applicants.

Article 4

Applications for special approval of innovative medical devices, should fill in the "Innovative Medical Devices special approval application form" (see Annex 1), and submit all supporting materials in comply with the procedural requirements of Article II. Materials should include:

1. The applicant enterprise legal person qualification certificate.
2. Products’ intellectual property rights and supporting documents.
3. Summary of the developing procedure and results of the products.
4. Technical documents, shall at least include:                                                                                                                                   4.1.    The intended usage of the product;                                                                                                                                       4.2.    Working principle / mechanism;                                                                                                                                         4.3.    The main technical specifications and their basic reasons, specific requirements for main raw materials and key components, main manufacture process and flow chart, testing methods for main technical specifications index.
5. Supporting documents for product innovation, include at least:                                                                                                     5.1     Investigation report issued by information or patent reference institute;                                                                             5.2     Academic papers, monographs and documents review which are published by core journals and can fully explain the clinical application value of the product.                                                                                                                                                     5.3     Analysis and comparison of similar products which are already on the market at home and abroad (if any).               5.4     Innovation contents of the product and its significant value in clinical application.
6. Product risk management report.
7. Product specification (sample).
8.  Other materials which help to prove the product complies with article 2.
9. Overseas applicant shall entrust business entity in China as its agent, or its agency  in China,  to apply for the registration, and submit the following documents:                                                                                                                                                               9.1     Power of attorney of overseas applicant entrusted agent or its agency in China to apply for innovative medical device special approval process.                                                                                                                                                                       9.2     Letter of commitment from agent or working body agency (organization) in China.                                                   9.3     Agent business license or registered certificate of applicant’s agency in China.
10. Statement of authenticity for all submitted materials

 Application materials should be in Chinese. If the original language is in foreign language, it shall have Chinese version.

Article 5

A domestic applicant shall apply for special approval of innovative medical devices from local provincial FDA. The provincial FDA should conduct the first review to check whether the application conforms to article2 inthis procedure, and issue preliminary opinion within 20 working days. The provincialFDA shall notify the applicant if the application does not meet the requirements of Article 2 in the first trial. For those which meet the requirements of Article 2, the provincial FDA should submit all information and preliminary observations to the CFDA administrative acceptance service center.

The foreign applicant shall submit application to CFDA for special approval of innovative medical devices. CFDA service center shall conduct formal examination of the application upon receiving, and accept only those complying with the procedural requirements of Article 4.

Article 6

Administrative acceptance service center of CFDA shall issue an accepting number to application for special approval, with accepting number formatted as:械特××××1-×××2, in which “××××1 ”is the year of application, and “×××2”is the serial number of the product.

Article 7

CFDA medical device technical approval center set up a review office for innovative medical devices (Hereinafter referred to as Innovative medical instrument examination office), it shall review innovative medical device special approval application.

Article 8

After CFDA accepts the “innovative medical device special approval application”, Innovative medical device examination office will call on experts to conduct a review, and give out opinions within 40 workdays of acceptance.

Article 9

After being reviewed by the Innovative medical device examination office, the applicant and product name will be published on the website of medical device evaluation center. The publishing time should be no less than 10 workdays. If there is any objection, the objection shall be evaluated before a final decision is made.

Article 10

After the Innovative medical device examination office makes final decision, the review result shall be sent to applicant by written notice. For domestic applicant, one copy shall also be sent to applicant’s provincial supervision and management of food and drug administration (format is in attachment 2).

Article 11

During the review of “innovative medical device special approval application”, the Innovative medical instrument examination office should also classify the medical devices. For domestic application, if the product is classified as Class I or Class II, relevant “Provincial supervision and management of food and drug” can go on the follow-up work and review according to this process.

Article 12

For those innovative medical devices which can be approved according to this procedure, applicant’s “provincial supervision and management of food and drug administration” shall assign a person to communicate with the applicant and provide guidance as applicant required and put priority to handle it once receiving application for inspection and Quality management system from the applicant.

Article 13

For innovative medical device, the medical device testing institute, when conducting registration tests, shall evaluate the registration product standard submitted by manufacturer, and if there are any questions, shall provide amending advice to manufacturer timely.

Article 14

Medical device testing institute shall give priority to do medical device registration tests after getting the test samples, and give out test reports. Registration products standards (which is pre-evaluated by medical device testing institute) and “pre-evaluate feedback forms of medical device which is intended to register” shall also be given out and with stamp of testing institute.

Article 15

Clinical trials for innovative medical device shall conduct according to requirements of medical device clinical trial related regulations. The food and drug supervision and administration department shall make supervision and inspection according to the process of clinical trials.

Article 16

If innovative medical device clinical study work need significant modification, such as amendment of clinical trial protocol, adjustment of usage, specification and models, intended use, scope of application and target users, applicant shall evaluate the influence on medical device’s safety, effectiveness and quality controllability. If the main working principle or mechanism of action has changed, shall reapply for “the innovative medical device special approval application” according to this approval procedure.

Article 17

For innovative medical device, before the acceptance of product registration application and during the technical review, CFDA shall assign specially-assigned person to communicate with applicant according to their requirement, provide guidance, and discuss relevant technical questions together.

Article 18

For innovative medical device, applicant can fill an application form about innovative medical device exchange and communication. Then apply for communicating the following issues with CMDE/CFDA.

1. Significant technology issues.
2. Significant safety issues.
3. Clinical trail proposal.
4. Periodic summary and evaluation of clinical trials results.
5. Other important questions need to be discussed with CMDE.

Article 19

CMDE (CENTER FOR MEDICAL DEVICE EVALUATION. CFDA) shall review Communication application and relevant materials submitted by applicant in time, and inform applicant the review result (see attachment 4). If CMDE agrees to communicate, shall inform the applicant for questions need to be discussed, and agree the communication form, time, site, participants with applicant. A record shall be made for the communication and be signed by both sides, and it would be regard as reference for follow-up study and review of this product.

Article 20

After CFDA accepting innovative medical device registration application, shall mark the registration application Article as “innovative medical device”, and conduct registration documents moving in time.

Article 21

The accepted innovative medical device, CMDE-CFDA shall give priority to technical review.  After the technical review, CFDA shall give priority to administrative examination and approval.

Article 22

Belongs to one of the following circumstances, CFDA can terminate the program and inform the applicant:

1. The applicant voluntarily request to terminate.
2. The applicant did not perform the corresponding obligations according to the stipulated time and requirements.
3. Applicant provide fake and false information.
4. After experts review meeting, confirm the product shall not be managed according to this procedure.

Article 23

During carry out this procedure, CFDA shall enhance communication and exchange with every departments of the State Council, understand research and development progress of innovative medical equipment in time.

Article 24

Emergent public health event emergency required medical device, shall according to “medical device emergency examination and approval procedures” to conduct.

Article 25

Medical device registration management requirements and regulations, this procedure is not involved, shall conduct in accordance with “Medical Devices Registration Administration Method” and other relevant provisions.

Article 26

This process will be put into force since March 1^st, 2014

  

Attachment:

Attachment 1: Application form for special approval procedures of innovative medical equipment.

Attachment 2: Review notice for innovative medical device special approval application.

Attachment 3: Communication application form of innovative medical device.

Attachment 4: Reply notice of communication for innovative medical device.