On October 29, 2020, CMDE announced a Notice for the registration of urgent clinically needed medical devices. These medical devices are used for the treatment of diseases that are seriously life-threatening and for which there is no effective treatment. more…
On October 30, 2020, CMDE announced its preparation of Performance Evaluation for Framework Guidelines for Pathological Image AI Analysis Software and Clinical Evaluation for Pathological Image AI Analysis Software. more…
On October 19, 2020, NMPA released an Announcement Regarding the Pilot of Electronic Registration Certificate (2020, No. 117). The electronic registration certificate of medical devices will be piloting from October 19, 2020 for providing more efficient and convenient government services. more…
On October 15, 2020, CMDE announced its preparation of Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of Intravascular Catheters (draft). “Intravascular catheter” in this guideline refers to the partial or entire insert or implanted cardiovascular system, more…
On October 13, 2020, CMDE announced its preparation of National Medical Device Quality Audit Procedure (draft). This Procedure includes the following steps: protocol formulation, implementation and sampling, audit, re-audit, audit result release, more…
