Announcement on the Consultation Arrangement for Pre-acceptance Technical Questions on Medical Device Registration (July–August 2026) – No. 19 of 2026

Time:2026-07-07

The Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) officially released the Announcement on the Arrangement of Preapplication Technical Consultation for Medical Device Registration (JulyAugust 2026)(No. 19 of 2026) on June 16, 2026, with the public notice posted on its official website the following day. This regular update gives medical device manufacturers a clear view of which review departments will be on duty for onsite consultations over the next two months, helping them better prepare their presubmission technical questions.

 

According to the schedule, the rotating duty teams for Friday afternoons are as follows: July 3, July 24, and August 14 will be covered by Review Department I, Review Department II, and Clinical and Biostatistics Department I; July 10, July 31, and August 21 by Review Departments III, IV, and V; and July 17, August 7, and August 28 by Review Department VI, Clinical and Biostatistics Department II, together with the General Business Department. This rotation ensures that applicants can directly engage with the specific review divisions most relevant to their product types.

 

Each consultation day offers 20 onsite slots, which must be reserved in advance following the procedures set out in the Centers earlier Notice No. 30 of 2025 (issued on December 23, 2025). For those who fail to secure an onsite appointment, the CMDE also accepts written inquiries via email, providing a convenient alternative. Notably, while the branch centers follow the same consultation hours as the headquarters, they are not bound by the department rotation, giving applicants in those regions greater flexibility to seek assistance from any division as needed.

 

Consultations are held every Friday from 1:30 PM to 4:30 PM (excluding statutory holidays), and applicants are reminded to take a queue number before 3:00 PM. The venue is located at 1/F, Building 2, Zone 1, No. 22 Guangde Street, Beijing EconomicTechnological Development Area.