Recently, the National Health Commission released a notice about its adjustment of the large medical device allocation plan from 2018-2020. The new plan will increase the number of large medical devices by 2,671, more…
On August 21, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Cryptococcal Antigen Detection Reagent (draft). The “cryptococcal antigen” referred to in these guidelines is “cryptococcal capsular polysaccharide antigen”. more…
In July 2020, NMPA has approved a total of 102 medical devices. 73 of them are domestic Class III medical devices, 11 of them are imported Class III medical devices, 17 of them are imported Class II medical devices and one of them is a Taiwan medical device. more…
On August 20, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Rotavirus Antigen Detection Reagent (draft). This Guideline applies to reagents that qualitatively detect rotavirus in human stool samples or other applicable samples on the basis of antigen antibody reaction. more…
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…
