“Full name” of pre-submission consultation is technical consultation about medical devices registration before application acceptance.
The scope of pre-submission consultation is primarily oriented toward technical issues before application for medical devices registration, excluding associated technical issues throughout the technical evaluation.
2.Application of Pre-submission Consultation
Time: Every Friday from 1:00 pm to 4:00 pm Address: Administrative Service Hall, Dacheng Square, Xuanwumen West Street, Xicheng District, Beijing
Domestic manufacturing enterprises should take the letter of authorization from the registration applicant that specifies the relevant matters entrusted, the valid personnel ID and Registration Form for Consultation of CMDE.
Overseas manufacturing enterprises should take the letter of authorization in which the overseas manufacturing enterprises designate the domestic enterprise legal person as agent, as well as one in which relevant entrusted contents are covered issued by the domestic agent, the valid personnel ID and Registration Form for Consultation of CMDE.
3.Procedures of Pre-submission Consultation
Sign up according to the requirements of NMPA.
Select the reservation channel that corresponds to your application. Currently, there are three reservation channels (I, II, III) available on the online reservation system for pre-submission consultation. The on-line reservation system is available from 7:00am to 23:00pm. Meanwhile, you can fill out the “Registration Form for Consultation at CMDE” and upload the form. Fill out the form accurately with at most five questions concerning the consultation. The questions shall correspond to the responsibilities of the department providing the consultation, and be listed in a simple form of questionnaire.
Be punctual for the consultation as scheduled.
Walk-ins (without prior reservation or reservation is not registered) may take an on-site waitlist number and make an on-site reservation depending on the availability and the schedule of consultation. Complete and submit the “Registration Form for Consultation of CMDE”. CMDE will confirm the reservation by e-mail later.
4.Note
CMDE will issue notices on a regular basis to announce the specific arrangements for Pre-submission Consultation. The administrative counterpart shall select the appropriate department to make a reservation, in accordance with the consultation arrangements.
