Innovative priority medical devices

Code of practice for communication and exchange of registered technical review

Article 1 To implement the reform requirements of medical device review and approval system,Encourage medical device innovation,Guarantee the clinical use demand of medical devices,Strengthen the technical evaluation center of medical devices Hereinafter referred to as the center Communication with the applicant,basis Special review procedure for innovative medical devices Announcement of the State Drug Administration2018Year83number and Priority approval procedure for medical devices Announcement of the former State Food and Drug Administration2016Year168number ,Develop this specification.

Article 2 Innovative medical devices and priority approved medical devices in this specification refer to those that have agreed to Special review procedure for innovative medical devices Hereinafter referred to as the special review procedure Innovative medical devices and devices reviewed in accordance with Priority approval procedure for medical devices Approved domestic category III and import Category II Class III medical devices.

Article 3 Communication referred to in this specification,It refers to the innovative medical device after the publicity of the review results,Review department and clinical and biostatistics Department Hereinafter referred to as clinical department Propose active communication with the applicant,And before accepting the application for registration of innovative medical devices Technical review stage and technical review stage of giving priority to the approval of medical device registration application,At the request of the applicant,Communication between the evaluation department and the clinical department and the applicant on the matters of registration application.

Article 4 For innovative medical devices,The comprehensive business department shall publish the review results after the publicity5Within working days,Confirm the personnel of the review team according to the qualification of the reviewers,Products involving the Yangtze River Delta and Dawan District,The review team shall allocate qualified reviewers from the Yangtze River Delta sub center for technical review and inspection of medical devices of the State Food and Drug Administration and Dawan sub center for technical review and inspection of medical devices of the State Food and drug administration,At the same time, inform the corresponding evaluation department and clinical department of the product information and review results.After receiving the review results, the review department and clinical department shall timely organize the first communication with the applicant In principle, no more than10Working days ,The review department shall take the lead in formulating the form and time of communication and exchange meeting.

Article 5 The contents of the first communication meeting shall include

one Understand product development progress
two Understand the major technical problems encountered by the applicant at this stage
three Understand the work arrangement of the applicant's registration and declaration
four Formulate the next communication work plan and work tasks of both parties.

Article 6 The review department and clinical department shall record the contents of the first communication meeting,And before applying for registration of the product,Actively communicate with the applicant at least once a year1second,Understand product progress.

Article 7 The applicant shall designate at the first communication meeting1Contacts,The contact person should be familiar with medical device registration regulations.The applicant shall communicate with the project manager through the contact person,The project manager only contacts this contact person.If the contact changes,The applicant shall inform the project manager in time.

Article 8 Before acceptance of innovative medical device registration application Technical review stage and technical review stage of giving priority to the approval of medical device registration application,When the applicant needs to communicate relevant technical issues,You can log in to the medical device technical evaluation and consultation platform-Innovation priority communication Hereinafter referred to as the consulting platform ,Fill in the application form as required,Check the corresponding column according to the type of consultation question Non clinical evaluation problems Clinical evaluation problems ,List specific communication issues one by one,And submit relevant materials.

Article 9 For general technical issues,Applicants can use the telephone Communicate with the corresponding departments of the center by e-mail.

Article 10 Communication application under the following circumstances,After being reviewed and approved by the corresponding department,Communication meetings can be held
one Major technical issues
two Major safety issues
three Clinical trial protocol
four Summary and evaluation of phased clinical trial results
five Special communication on the contents of information supplement and correction notice
six Other important issues requiring communication.

Article 11 The project management department is responsible for the comprehensive management of innovation priority medical device registration technical review and communication and the technical support of the consulting platform,The evaluation department and clinical department are responsible for communication within the scope of their responsibilities.

Article 12 After the consultation platform receives the communication application,The question type checked in the application form will be automatically identified,And related to the project manager information of the corresponding project in the review system.If it is only a clinical evaluation question,The consulting platform will automatically assign the application to the project manager of the clinical department If it is only a non clinical evaluation question,The consulting platform will automatically assign the application to the project manager of the review department If both clinical evaluation questions and non clinical evaluation questions are included,The consultation platform will automatically assign the application to the project managers of the evaluation department and the clinical department at the same time.

Article 13 For communication applications involving only clinical evaluation issues or non clinical evaluation issues,After receiving the communication application,The project manager of the corresponding department shall review the application form and data submitted by the applicant,Whether to hold a meeting Meeting data requirements Meeting date place Agenda and full consultation between participants and applicants.

Article 14 It is considered necessary to hold a communication meeting after review,The project manager shall fill in the approval form on the consulting platform,The meeting can be organized and held after being approved by the main person in charge of the Department.It is considered unnecessary or disagreed to hold a communication meeting after review,The reasons shall be indicated in the approval form,Reviewed by the principal of the Department,Approved by the director in charge.

Article 15 The project manager of the review department or clinical department shall apply for approval at the communication meeting3Notify the applicant of the results within working days,And fill in the reply form on the consulting platform.Determine the need for a communication meeting,Indicate the topic of communication Meeting time Location, participants and other information,And inform the project manager of the Cooperation Department of the registration application,The project manager of the cooperation department may decide whether to participate in the communication meeting according to the actual situation Determine whether they do not agree to hold a communication meeting,The reasons for disagreeing with the communication shall be indicated,And inform the applicant of the results.

Article 16 For communication applications involving both the evaluation department and the clinical department,The project managers of the two departments shall review the data within their respective responsibilities,Whether to hold a meeting Meeting data requirements Meeting date place Agenda and full consultation between participants and applicants,The project managers of the two departments shall fill in the approval form respectively.If a meeting is required, the meeting can be held with the approval of the main person in charge of the Department If it is not necessary or agreed to hold a meeting, it shall be reviewed by the main person in charge of the Department,Approved by the director in charge.

Approved communication application,The project managers of the two departments shall fill in the reply form in accordance with Article 11.The project manager of the review department shall inform the applicant of the results.

After consultation, only the evaluation department or clinical department needs to hold a communication meeting,According to Article 13 Article 14 implementation.

Article 17 Determine the of holding communication meeting,The communication meeting is generally arranged after the communication application is approved20Held within working days Except that experts need to be invited .To ensure the quality and efficiency of communication meetings,The project manager of each department shall fully negotiate with the applicant.Participants of the center shall review the meeting materials before the communication meeting,And form preliminary opinions.For those involving both the evaluation department and the clinical department,The project manager of the review department shall take the lead.

Article 18 The applicant shall submit the paper or electronic data required for the communication meeting to the project manager as required,Electronic data shall be submitted to the work mailbox of the project manager.The project manager shall review the data within the corresponding scope of responsibility,In case of any deficiency, the project manager can ask the applicant to supplement more sufficient technical data according to the product situation,To ensure the quality of communication.

Article 19 For the communication meeting to be attended by experts,Follow the following procedure
one For cases involving only the evaluation department or clinical department,The project manager of the corresponding department shall apply and fill in the approval form,List specific issues that need to be communicated,Formulate the professional direction of the members of the expert group If any, designated professionals and experts,It shall be indicated in the approval form Number of people,Experts and institutions to be avoided,Suggested meeting time period.Reviewed by the principal of the Department,After being approved by the director in charge, it shall be transferred to the comprehensive business department For cases involving both the evaluation department and the clinical department,After full consultation between the project managers of the two departments,Fill in the approval form on the consulting platform according to the requirements of the preceding paragraph,reference resources Expert consultation meeting of medical device technical evaluation center/Operation specification of expert public demonstration meeting Handling procedures specified in Article 4.Inviting experts to the communication meeting does not need to be considered by the sub Technical Committee.
two After receiving the approval form, the comprehensive business department,Randomly select experts from the expert advisory committee according to the proposed professional direction,Experts designated by the application department if there be Merge to form an expert group,And organize the meeting according to the suggested meeting time After determining the duration of the session,The general business department shall inform the project manager of the application department of the meeting time.
three After receiving the notice from the comprehensive business department,The project manager of the application department shall fill in the reply form in accordance with Article 11,Inform the applicant and the project manager of the Cooperation Department of the results,At the same time, inform the applicant to bring the information required for the meeting to the meeting site.Involving two departments,The project manager of the review department shall take the lead.

Article 20 The communication meeting is generally presided over by the project manager Involving review department and clinical department,It is presided over by the project manager of the review department ,Follow the pre-determined agenda of the meeting,In principle,Members of the review team shall participate in the whole meeting,A specially assigned person shall take minutes of the meeting.

Article 21 After the communication meeting,The meeting minutes shall be written in time according to the requirements of the meeting minutes template,The project manager or review team member of the corresponding department shall be responsible for writing the meeting opinions on the corresponding topics within the responsibility scope of the Department,It shall be reviewed and confirmed by the main person in charge of the Department,Involving only the evaluation department or clinical department,The meeting opinions are the minutes of the meeting Involving both the evaluation department and the clinical department,The review department shall summarize and form the meeting minutes.

Article 22 After the meeting, the project manager shall20Send the meeting minutes to the applicant within working days,Signed and retained by both parties,The electronic version is uploaded to the consulting platform by the project manager,As an important reference and record for follow-up technical review.

For the problems with clear opinions and suggestions, there will be no repeated communication and exchange.

Article 23 Application form related to this specification Approval form See the template of reply sheet and meeting minutes for details Regulations on management of communication meeting system between medical device technical evaluation center and registration applicant .

Article 24 This specification is interpreted by the medical device technical evaluation center.

Article 25 This specification shall come into force as of the date of promulgation.2020year1month10Issued on Regulations on management of technical review, communication and exchange of innovative priority medical device registration (Approval and issuance of drug supervision equipment 2020 2number)Repeal at the same time.