One, the project name: Class II medical devices (general products) quasi-production registration
Two, the license content: Shandong Province, "Class II Medical Device Registration Certificate" of the quasi-production registration
Three, the legal basis: "Supervision and Administration of Medical Devices Regulations", "Measures for the Administration of Medical Device Registration" (State Food and Drug Administration Decree No. 16) Drug Administration Decree No. 16).
Four, fees: No
V. Quantity Limit: No quantity limit
Six, the submission of materials directory:
1. "Shandong Province, the second class of medical device registration application form";
2. Medical device manufacturer qualification certificates, including the "Medical Device Manufacturing Enterprise License" and "industrial and commercial business license" copy copy;
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3. product technical reports;
4. safety risk analysis report;
5. the use of product standards and instructions;
6. product performance self-test report;
7. medical device testing organizations issued by the product registration test report;
8. medical device clinical trial data or its supporting materials;
< p>9. medical device manual in duplicate;10. product production quality system assessment (certification) of the valid documents;
11. food and drug supervision and management department that should be submitted to other materials.
Seven, the material format requirements:
(a) a copy of the declaration materials in one form, using A4-size paper printing or copying, the content is complete, clear, not altered, in accordance with the sixth item of these instructions to submit the materials in the order of the directory.
(ii) Copies of the declaration materials must be clear.
Eight, the application process:
Application → SDFDA Acceptance Center form of review and acceptance (5 days) → SDFDA Evaluation Center technical review → SDFDA review and decision (14 days) → SDFDA Acceptance Center to serve the decision (10 days).
9, licensing procedures:
(A) Acceptance:
Applicant to the SDFDA acceptance center to apply, in accordance with the sixth item of this notice to submit materials directory of the requirements of the application materials, the SDFDA acceptance center of the form of application materials for review. Application matters are not required by law to obtain administrative licenses, the applicant shall be immediately informed of inadmissibility; application matters do not fall within the purview of the administrative organ, it shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative organ; application materials can be corrected on the spot, the error, the applicant shall be allowed to correct on the spot; application materials are incomplete or do not meet the statutory form, it shall be On the spot or within five days to inform the applicant of all the contents of the need to make corrections, late notification, from the date of receipt of the application materials shall be accepted; application matters within the purview of the administrative organ, the application materials are complete, in line with the statutory form, or the applicant in accordance with the requirements of the administrative organ to submit all the corrections to the application materials, the application for administrative licenses shall be accepted.
(B) Review:
SDFDA acceptance of the materials accepted by the Center, will be sent to the SDFDA Evaluation Center for technical review in accordance with the prescribed procedures.
(C) Decision:
SDFDA receives the technical review materials completed by the SDFDA Review Center, and then makes a decision on whether to permit or not within 14 days.
(D) delivery:
SDFDA acceptance center within 10 days from the date of the administrative licensing decision to the applicant.
X. Commitment time limit: 14 working days from the date of acceptance of the administrative licensing decision.
xi, the implementation of the authorities: Shandong Provincial Food and Drug Administration
xii, the validity and renewal: medical device product registration certificate is valid for four years. The licensee should be in the product registration certificate expires within six months before the expiration date, apply for re-registration.
Thirteen, Consultation and Complaints:
Consultation: Shandong Provincial Food and Drug Administration Medical Device Supervision Department
Complaints: Shandong Provincial Food and Drug Administration Supervision Office