NMPA issued the “Clinical Evaluation Guideline with Predicate Comparison of Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) Equipment (Draft)” for feedback on February 18,...
The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report.
These published review...
The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical...
NMPA published the “Draft Guideline on Clinical Trial of Peripheral Drug-Coated Balloon Catheters” on February 5, 2024 for feedback. Feedback needs to be submitted...
Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the...
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and...
NMPA affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform summarized six AI related guidelines released in 2023. These documents are “based on the characteristics...
As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...
The NMPA granted innovation approvals to Zap Surgical’s head and neck X-ray stereotactic radiosurgery system and issued a review report.
It is the seventh imported...
