The application process for the discontinuation of the three classes of medical devices

In the medical industry, according to the different degree of danger to the human body and the level of management needs, the medical equipment in accordance with the three categories of different respectively. Correspondingly, each category has its own provisions of this category, the more dangerous then the provisions and requirements are more stringent, so the approval process for Class III medical devices is how?

First, acceptance

1. Acceptance of the path

through the medical device registration electronic filing information system declaration, without submitting paper information, the application information should be consistent with the corresponding medical device registration application electronic submission of technical guidelines.

The submission of paper information should be consistent with the corresponding medical device registration application electronic submission of technical guidelines for electronic filing of catalog form, while the need to submit the corresponding information electronic documents.

2. Acceptance of the audit

State Drug Administration Medical Device Technical Review Center in the acceptance of the link, the product registration, change of registration, clinical trial approval application matters in accordance with the requirements of the file review of the corresponding application for registration application information for review, the corresponding registration application information into the technical review of the completeness of the link, compliance, consistency of the judgment. The rest of the application matters in accordance with the form of audit requirements for review.

(1) The applicant to submit the registration application information for signing, and according to the acceptance of the audit specifications for the distribution of acceptance and review path.

(2) According to the acceptance of audit specifications, the application matters to carry out the audit. Product registration, change of registration, clinical trial approval application matters by the reviewer according to the appropriate file review standards for acceptance and review. For other applications by the reviewer according to the form of audit requirements for acceptance and review.

(3) the application belongs to the terms of reference of the administrative organs, application information is complete, in line with the requirements for acceptance, to be accepted, issued a "Notice of Acceptance", the need for the applicant to pay fees, issued a "Notice of Payment", "Notice of Acceptance" "Notice of Payment" should be stamped with a special chapter of the administrative organs and indicate the date.

(4) application information can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot.

(5) application information is incomplete or does not meet the admissibility requirements, the applicant should be informed of the need to make corrections within five working days of all the contents, and issue a "Notice of Corrective Material", the late notification, since the date of receipt of the application information is admissible.

(6) of the application does not fall within the purview of the administrative organ, it should be made immediately inadmissible decisions, issued a "notice of inadmissibility", stamped with the special seal of the administrative organ and indicate the date.

(7) Since the date of acceptance of the application within three working days, the State Drug Administration Medical Device Technical Review Center to carry out technical review.

Second, the technical review (60-90 working days)

1. Review

(1) Responsibility: According to the technical review of the department's operating specifications determined by the technical review staff.

(2) the main review requirements and responsibilities: in accordance with relevant laws and regulations, statutory procedures and technical review requirements, according to the applicant's application, the safety, effectiveness and quality of products to be marketed for systematic evaluation of the study and its results, to determine whether the content of the registration is in line with the relevant provisions of the product registration of medical devices, and issue a review opinion; change of the content of the registration of medical devices for review to determine whether the content of the change of registration is in line with the change of registration. Change the content of registration to determine whether the change of registration is consistent with the relevant provisions of the change of registration, the issuance of review comments; the continuation of the content of the registration to determine whether the continuation of the registration of the relevant provisions of the issuance of review comments; the approval of clinical trials in accordance with the "Supervision and Management of Medical Devices Regulations" Article 27 of the comprehensive analysis, the issuance of review comments.

2. Review

(1) Responsibility: State Drug Administration Center for Technical Review of Medical Devices review department or its entrusted personnel.

(2) review requirements and responsibilities: the review of the review, if necessary, review the registration application information, to determine the completeness of the review comments, standardization and accuracy, and put forward the review. Determine the review process in line with the provisions of the relevant review procedures, to achieve a consistent review scale.

3. Issuance

(1) Responsibility: State Drug Administration Medical Device Technical Review Center in charge of the director or authorized personnel.

(2) issuance requirements and responsibilities: review and review of the review comments, confirm the conclusions of the review, the issuance of review reports.

4. Other requirements

(1) technical review process, if necessary, access to the original research data and other required information.

(2) need to correct the information, the State Drug Administration Center for the Technical Review of Medical Devices should inform the applicant once the need to correct all the contents. The applicant should be in accordance with the requirements of the corrective notice within 1 year to provide additional information; State Drug Administration Center for Technical Review of Medical Devices shall receive additional information from the date of 60 working days (40 working days for the approval of clinical trials) to complete the technical review.

(3) should be carried out in accordance with the quality management system verification, according to the relevant provisions of the start.

Third, the administrative approval (20 working days)

which change the registration, continuation of registration, clinical trial approval of the administrative approval by the State Drug Administration Medical Device Technical Review Center, in accordance with its operational specifications. Evaluation report issued after the completion of the administrative approval.

For the administrative approval of product registration, the requirements are as follows:

1. Audit

(1) the responsible person

State Drug Administration Medical Device Registration Management Division of the registration office audit staff.

(2) audit requirements

to determine the application belongs to the department's approval of the scope of responsibility; review procedures in line with relevant regulations and work procedures; technical review report is complete and standardized; review time frame is in line with statutory requirements; technical review of whether the conclusion is clear.

(3) duties

According to the audit requirements, put forward the audit opinion, fill out the administrative review record of the technical review report, administrative review record to the approving officer.

2. Approval

(1) Responsible

State Drug Administration of Medical Devices Registration and Management Division or the head of the Division.

(2) approval requirements

review of the audit opinion issued by the reviewer; determine whether the product is registered in this application for registration.

(3) job responsibilities

The import of Class II medical device registration application project meets the approval requirements, the head of the Division to put forward the approval of the opinion, fill out the administrative review record will be the technical review report and administrative review of the record sent to the head of the Division.

To meet the approval requirements of the domestic and imported Class III medical device registration applications, the Division head of the approval of the opinion, fill out the administrative review record will be reported to the competent bureau chief after the review record.

For those who do not meet the approval requirements, the approval of the opinion, fill in the review record will be returned to the review of the technical review report, review records.

3. Validation

(1) Responsible

State Drug Administration of Medical Devices Registration Management Division or the State Drug Administration in charge of the leadership of the Bureau.

(2) validation requirements

on the approval of the approved personnel issued by the approval of the review; final approval of the application for registration of the product is registered.

(3) Job responsibilities

State Drug Administration Medical Device Registration Division is responsible for the import of Class II medical device registration applications, in line with the validation requirements to make the decision to approve the registration or not administrative licensing, the issuance of relevant documents.

The State Drug Administration is responsible for the leadership of the territory and the import of Class III medical device registration applications, in line with the validation requirements to make the approval of registration or not administrative licensing decisions, the issuance of relevant documents.

Fourth, the approval (documents) production (10 working days)

1. Approval (documents) production requirements

(1) the production of "medical device registration certificate" "medical device registration changes (for the record) document" content is complete, accurate and error-free, stamped with the administrative organs of the special chapter is accurate and error-free.

(2) the production of the "decision not to administrative license" must be written in the reasons for not administrative license, and indicate the applicant's right to apply for administrative review or administrative litigation according to law, as well as complaint channels.

(3) other licensing instruments should be consistent with the relevant requirements of the official documents.

2. Duties

The permit is granted, the production of "medical device registration certificate" or "change of registration of medical devices (for the record) file", stamped with the administrative organs of the special seal.

For non-permit, the production of "no administrative license decision", stamped with the administrative organs of the special seal.

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