Acceptance scope: to re-registration of the domestic third class of medical devices and overseas medical device registration certificate extension application.
Fee basis: no fee
Processing conditions:
I, has been accepted for re-registration of the project technical review more than the prescribed time limit (60 working days).
Second, has been accepted or not accepted the re-registration project, due to the testing center causes the statutory registration of the relevant product testing more than the normal testing cycle.
Three, has been accepted or not accepted re-registration project, due to the relevant product quality management system assessment time delay.
Requirements for application materials:
I, stamped with the official seal of the manufacturer's application for extension, the application content should be clear and complete.
Two, stamped with the official seal of the issuing unit of other relevant supporting information.
Three, stamped with the official seal of the manufacturer's commitment to the enterprise in the original certificate of registration within the validity of the relevant products without major quality incidents and serious adverse events.
Four, stamped with the official seal of the manufacturer of the relevant product re-registration acceptance of a copy of the notice (limited to the relevant products have been accepted for re-registration of the extension of the application program).
Procedures:
An administrative acceptance of the service center in accordance with the appropriate acceptance criteria for the extension of the enterprise registration certificate application information for formal review, for compliance with the acceptance criteria, should be in accordance with the provisions of the relevant transfer procedures, the application information will be transferred to the Medical Devices Technology Evaluation Center or the Bureau of Medical Devices Division of the Product Registration Department.
(A) has been accepted for re-registration of the extension application should be transferred to the Medical Device Technical Review Center after acceptance to continue to review. The review is as follows:
1. For the review of more than the prescribed time limit, verify the registration acceptance time.
2. For registration testing more than the normal testing cycle, verify the testing center issued by the seal to confirm the relevant information.
3. For the quality management system assessment of the delay in the case, verification of the provincial bureau issued by the relevant information confirmed by the seal.
4. Verify whether the official seal of the production company submitted to the seal of the commitment to the enterprise in the original certificate of registration within the validity of the relevant products without major quality accidents and serious adverse events.
5. Verify whether the official seal of the manufacturer submitted a copy of the relevant product re-registration acceptance notice.
(ii) not accepted for re-registration of the extension application should be transferred to the Division of Medical Devices after acceptance of the product registration to continue to review. The review is as follows:
1. For registration testing more than the normal testing cycle, verify the testing center issued by the seal to confirm the relevant information.
2. For the quality management system assessment of the delay in the case, verify the provincial (autonomous regions and municipalities directly under the Central Government) Bureau issued by the relevant information confirmed by the seal.
3. Verify whether the official seal of the production company submitted to the seal of the commitment to the enterprise in the original certificate of registration within the validity of the relevant products without major quality accidents and serious adverse events.
Second, the Medical Device Technical Review Center reviewers since the receipt of the extension application information, should be based on the review criteria within 20 working days to review the application information, the extension of the approval of the proposal. To agree to the extension, it should be issued comments, transferred to the Division of Medical Devices for review.
Audit the following:
1. Confirmation of the review beyond the prescribed time limit (60 working days), or other documents provided by the enterprise to support the extension.
2. Confirmation of the enterprise to apply for an extension of the project re-registration of the quality management system assessment conclusions qualified.
3. Confirmation of the enterprise has committed to the original certificate of registration within the period of validity of the relevant products without major quality accidents and serious adverse events.
Has entered the administrative approval stage of the registration declaration project, to the Division of Medical Devices to inform the situation, transferred to the Division of Medical Devices for review.
Third, the Division of Medical Devices since the receipt of the extension application information, should be within 20 working days with reference to the audit criteria for the validation of the opinion, and the extension of the approval of the document transferred to the Administrative Acceptance Service Center, the Administrative Acceptance Service Center to continue to complete the extension of the approval of the printing and production of the documents and fulfillment of the delivery process.