On August 13, 2020, CMDE announced its preparation of Technical Guideline on the Clinical Evaluation of Medical Magnetic Resonance Imaging System with the Same Variety (draft). This guideline applies to common MR systems as well as MR components of multimodal systems such as PET/MR systems. more…
On August 10, 2020, NMPA approved the registration of two “Diabetic Retinopathy Diagnostic Software with Fundus Photograph” produced by SiBionics and Airdoc respectively. Though the name of the two products are the same,the product compositions and intended uses of them are slightly different. more…
On August 4, 2020, CMDE announced its preparation of Technical Guideline on Human Parvovirus B19IgM/IgG Antibody Detection Reagents (draft). This Guideline covers general requirements for Human Parvovirus B19 IgM/IgG antibody detection reagents. more…
On August 4, 2020, CMDE announced its preparation of Technical Guideline on Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents (draft). The detection reagent for mycoplasma pneumoniae IgM/IgG antibody described in this Guideline refers to the reagent used for qualitative detection of mycoplasma pneumoniae IgM and/or IgG antibody in human serum, more…
Supplementary data pre-review service, is a consultation service provided by CMDE, whose application scope extends to initial registration, changes in licensing and approval of clinical trials of high-risk medical devices. Given the applicants only have one chance to submit the supplementary data, more…
On July 29, 2020, the medical device standard management center released a notice about information collecting on six medical device industrial standards (draft). All the six standards are listed in the table below. Opinions or suggestions are all welcomed to be filled in the information collection and registration form and submit it to the standard management center before September 30, 2020, via email. more…
On July 29, 2020, CMDE released a notice about information collecting on medical device of soft tissue repair biomaterial. This is the first batch of collection which mainly focuses on the Hernia Mesh and Dura Substitution. CMDE is collecting information from relevant units and institutions in this field, more…
On July 29, 2020, CMDE released its revision of the New and Revised Catalog of Medical Devices and ICD Products Exempted from Clinical Trials in 2020 (Draft). Devices such as Fluoroscopy Radiography X-ray Equipment, Disposable Aortic Punch, Surgical Zipper, etc. are all exempted from clinical trials now. more…
On July 29, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from June 9, 2020 to July 6, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
