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…
On September 29, 2020, CMDE has made further provisions on the trial implementation of electronic signature on registration declaration data of imported medical devices due to the different legal provisions on electronic signature in foreign countries (regions). more…
On September 29, 2020, CMDE announced its preparation of Registration Guideline on Disposable Injection Pen Needle (draft). In this Guideline, needle for injection pen refers to disposable sterile injection needle products used with injection pen, more…
