On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”). The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the “Prior Guidance”). There are three major changes under the New Guidance: (i) The scope of these inquiries is narrower; (ii) In-person inquiries are limited to three times per application; and (iii) Two new inquiry channels were added—an online platform and “CMDE FAQs.”
Under China’s medical device regulations, a “technical review” is CMDE’s substantive review of the marketing application (or subsequent amendment/renewal). CMDE does not grant formal meetings as a matter of right, unless the applicant is admitted to a prior pathway, such as the innovative device pathway (see our prior entry here). Applicants are, however, permitted to make short inquiries regarding their applications via different channels. The New Guidance provides for the channels to include in-person (on-site) inquiries at the agency, online platforms, and telephone inquiries.
Narrowed Scope of Inquiries
Previously, the scope of an inquiry in any matter related to technical review, i.e., the substantive review of a marketing application for a Class II or III device. Under the New Guidance, the scope of inquiry is limited to the content of a request for supplemental information issued by CMDE with respect to the marketing application of a medical device. This request usually requires additional documentation or data (mostly from a technical perspective) to further support the market application of a medical device. The applicant may make the inquiry before submitting the materials required if the request is unclear.
Three On-site Inquiries
Previously there was an “Open Thursday” for on-site inquiries. Applicants could go to a designated site and ask representatives their CMDE questions. They were not limited to the number of questions.
The New Guidance instructs the applicant to make an appointment through CMDE’s online platform, which specifies the content requirement for the inquiries. The New Guidelines further limit the number of inquiries to three. CMDE will allocate no more than thirty minutes for each on-site inquiry.
In general, the onsite inquiry occurs within twenty business days from the date of the appointment.
Online Inquiries Permitted
The New Guidance states that online inquiries are intended for those relatively simple and easy-to-answer inquiries. If CMDE believes that an on-site inquiry will be more efficient, the online inquiry will be shifted to an on-site inquiry.
Feedback to the online inquiry is required to be provided within twenty business days from CMDE’s receipt of the said online inquiry.
New CMDE FAQs
CMDE FAQs will focus and provide feedback on some common questions from on-site, online and telephone inquiries. CMDE will release FAQs on a quarterly basis.
No Change for Telephone Inquiries
The process for telephone inquiries remains relatively unchanged. The scheduled time is still between 3:30 pm to 4:30 pm every Monday and Wednesday. Telephone inquiry is more focused on the content of the correction notice rather than the detailed technical review. CMDE may guide the applicant to make an on-site inquiry if the telephone inquiry is not adequate.
The New Guidance indicates that CMDE is reforming and expanding its meeting practices. Applicants should continue to examine the availability of different types of meetings to assist with their applications.