The Center for Medical Device Evaluation (the “CMDE”) recently clarified its requirements on supplementary information for medical device evaluation in connection with the registration of domestic Class III medical devices and imported medical devices with the China Food and Drug Administration (the “CFDA”).
Beginning June 1, 2013, when the CMDE requires supplementary information, it will notify the applicants of all requested documents in one notice. The applicants must submit all requested documents within 60 working days, unless the CMDE approves an extension. The extension may be given only once and will not be longer than 60 working days. However, a second notice may be issued by the CMDE for additional explanatory or demonstrative documents addressing outstanding questions arising from the review of supplementary information and the applicant must provide such additional information within 15 working days. Failure to provide all requested documents within the timeline or to provide satisfactory documentation will lead to CMDE’s proposal to the CFDA to disapprove the registration application.
To ensure correct interpretation and understanding of CMDE’s request for supplementary information, the CMDE will publish the contact information of the reviewers and offers access to the reviewers and their supervisory officials to allow telephone or face-to-face meetings, or written correspondence between the applicants and the CMDE. Should the applicants have any dissenting opinion on the request for supplementary information, they may file a written complaint to the general office under the CMDE to which the CMDE must respond after its review.
If you would like to discuss the foregoing or any other related matter, please contact Katherine Wang or your usual Ropes & Gray advisor.