On December 7, 2020, CMDE released five nomenclature guidelines on different kinds of medical devices. Products may be affected are: orthopedic surgery devices; blood transfusion, dialysis and extracorporeal circulation devices; passive surgery devices; more…
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by December 15, 2020. more…
On November 30, 2020, six overseas manufacturers voluntarily recalled seven different medical devices. The recalls are Class II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. For more information about the recall products, more…
On December 1, 2020, CMDE announced its preparation of Technical Guidelines on the Registration of Degradable Magnesium Orthopedic Implants (Draft). According to the current market research and development of degradable magnesium orthopedic implants, the Guidelines take magnesium metal bone screws as an example. more…
NMPA (CFDA) issued the “Guidelines on Product Adverse Event Risk Assessment for Medical Device Registrants” (No. 78 of 2020) on November 27, 2020. Based on the Guidelines, risk assessment of medical devices mainly includes but is not limited to the following aspects: more…
On December 1, 2020, NMPA granted Innovative Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise. This product can be used for the display, processing, measurement and analysis of chest CT images. more…
On November 23, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from September 7, 2020 to October 29, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
On November 26, 2020, CMDE issued a notification that the “Hepatitis B Virus (HBV) Nucleic acid Quantitative Detection Kit (PCR-Fluorescence method)” of Suzhou Tianlong Bio-technology Co.,Ltd. is proposed to obtain the priority pathway approval because it is listed in the national science more…
