On July 16, 2020, CMDE announced its preparation of 14 technical guidelines and a list of all these guidelines are listed below.
CMDE is collecting information from domestic and foreign manufacturers, universities, research institutes and clinical institutions, etc. who have relevant research experience. more…
On July 15, 2020, CMDE announced its preparation of the Technical Review Guidelines of Vision Screening Device (Draft). These guidelines apply to vision screening devices but not to optometrists (including desktop and handheld optometrists). more…
On July 14, 2020, CMDE announced its preparation of Technical Review Guidelines of Electronic Upper Gastrointestinal Endoscope (Draft). These guidelines are applied to electronic upper gastrointestinal endoscopes (excluding electronic duodenal endoscopes). more…
On July 10, 2020, CMDE announced its preparation of Framework Guidelines for Evaluating the Safety and Effectiveness of Nanomaterials Used in Medical Devices.
CMDE is collecting information from domestic and foreign manufacturers, universities, research institutes and clinical institutions, etc. who have relevant research experience. more…
In March 2018, the transformation from CFDA to NMPA, which emerged into State Administration for Market Regulation (SAMR), was to make the linkage between pre-market approval and post-market surveillance, to strengthen the market supervision for pharmaceutical and medical device products’ lifecycle, and to utilize the administrative resources in SAQSIQ to prevent bribery. more…
The unapproved devices can be clinically used in Hainan to collect real world data (RWD) and support its regulatory approval from NMPA. Under the policy, the scale-up usage and clinical data collection plan for Juvéderm VOLUX, an Allegan manufactured injectable dermal filler, was launched in Hainan Boao Medical Pilot Zone on July 3, 2020. more…
In responding to the COVID-19 epidemic, all countries urgently established their green pathways for the emergency approval of medical devices. Both the medical device emergency approval process in China and EUA authorization in the US are special evaluation systems established in response to major emergencies. Both have similarities and differences, as shown in the table below. more…
On June 28, 2020, the implantation of Artificial Iris produced by a German company – Human Optics is completed in Boao Lecheng, which is the first Artificial Iris implant operation in China. This Artificial Iris implant product is recently imported from the German company – Human Optics based on an Early and Pilot Implementation policy in Lecheng, Hainan. more…
