On August 19, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Genetic Deafness Related Gene Mutation Detection Reagents (draft). The intended uses of this Guideline are: in vitro qualitative detection of hereditary deafness gene mutations in human genomic DNA in peripheral venous blood or dry blood spot samples; more…
On August 19, 2020, NMPA intends to allow the following application to be subject to the innovative green pathway review procedures: In-Hospital Neutron Treatment System made by BCTC, IBS Angel™ made by Biotyx Medical and Aspheric Diffracted Multifocal Intraocular Lens made by Eyebright.
On August 17, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from July 7, 2020 to July 20, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
In July 2020, CMDE has released 1,414 pieces of information related to medical device approval, among which nearly 51% (728) of them are related to imported medical devices. Based on the information collected from the CMDE website, the registration of renewal (364, 50%) accounts for the majority more…
On August 15, 2020, the Innovative Drug Summit was held in Hainan. As the only Pilot Zone for RWD (real world data) research in China, Hainan (Lecheng) has already received 47 product applications from about 30 manufacturers so far. All the applications are targeting to be included in the 2nd batch of the pilot projects. The conduction of clinical real-world research can effectively shorten the time and reduce the cost of global innovative drug and devices entering the China market.
On August 13, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Group B Streptococcus Nucleic Acid Detection Reagents (draft). The Group B Streptococcus Nucleic Acid Detection Reagents mentioned in this guideline refers to the nucleic acid detection technology based on molecular biological methods. more…
On August 13, 2020, CMDE announced its preparation of Clinical Guideline on Companion Diagostics (CDx) for Marketed Anti-tumor Drugs (draft). Companion Diagostics (CDx) for Marketed Anti-tumor Drugs mentioned in this guideline refers to more…
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…
