Latest Clinical Exemption Catalogue Released! 2021-09-18 On September 18, 2021, NMPA has released measures for medical devices and IVD respectively. According to the Measures… Results Of Sampling Inspection On Medical Devices Released 2021-09-17 On September 15, 2021, NMPA issued the results of sampling inspection on medical devices. A total of 12… Oral Implant Surgery Navigation And Positioning Device Approved For Listing 2021-09-16 On September 14, 2021, NMPA has announced the approval of an innovative oral implant surgery navigation and positioning… Draft Guidance For The Preparation Of Product Technical Requirements And The Submission Of Clinical Trial Data Released 2021-09-15 Recently, CMDE of NMPA issued two new guidelines, including Guidelines for Registration Review of Preparation of Product Technical… A New Guideline For Intravascular Catheters Issued! 2021-09-08 On September 7, 2021, the NMPA released the Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of… A New Draft Guideline On Additive Manufacturing Metallic Implants Issued! 2021-09-07 Your feedback counts! On September 6, 2021, NMPA’s CMDE published the Draft Guideline for Registration Review on Quality Uniformity… Two Provisions For Medical Device Registration And Filing Issued In One Day! 2021-09-02 On August 31, 2021, China issued the Provisions for Medical Device Registration and Filing and the Provisions for… Five Products Enter The Pathway For Innovation And Priority Review 2021-09-02 On August 30, 2021, 5 products were approved by NMPA (former CFDA) to enter the innovation pathway and… NMPA AE And Recall Report In August 2021 2021-09-02 In August, NMPA has released 28 medical device recalls, 14 of which are imported products. The table below… Two Nomenclature Guidelines For Medical Devices Issued By NMPA 2021-09-01 On August 23, 2021, NMPA issued the Nomenclature Guidelines for Neurological and Cardiovascular Surgical Devices and the Nomenclature… Analysis For Registration Of Plastic Surgery Implants 2021-09-01 Plastic surgery implants are generally made of polytetrafluoroethylene (PTFE) and silicone rubber, which are used for filling the… China NMPA Released The Draft Guidance For Tissue Engineered Medical Products For Public Comments 2021-08-18 Your feedback counts! China NMPA technical review guidance documents tend to be more prescriptive. Once issued, all manufacturers… « Prev...246...1213141516Next