(I) Acceptance :
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center according to the requirements of the "Acceptance standards for domestic Class III and overseas medical device registration application dossiers"(SFDA Department of medical device supervision [2005] No. 111). Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.
(II) Review :
Once accepted, Administrative Service Center shall deliver the application dossiers to the Center for Medical Device Evaluation (CMDE) for technical review, which includes product testing and expert review, and shall not exceed 60days. But the time for the applicant’s rectification, which is based upon opinions after expert review, shall not be included in the time frame for licensing.
(III) Licensing decisions :
Upon receipt of the dossiers after CMDE technical review, CFDA shall make a decision for registration within 30 days, and written explanations shall be made for rejection of registration.
(IV) Delivery :
Within 10 days from the date of decision making of administrative examination and approval, CFDA Administrative Service Center shall deliver the decision to the applicants.
