China released the results of urgent approved clinical trials of medical devices against COVID-19.

On March 26, 2020, NMPA approved Allergan, Inc.’s registration of glaucoma implant, which is the first manufacturer to gain the approval with real world data in China. In June 2019, NMPA and Hainan Provincial Government jointly ran Hainan’s clinical real-world data pilot application. The real world data are used to justify the ethnic differences between China population and overseas population. The principle of real world data is focused on patient follow up data and the sample size is very small based on overseas clinical data. Bradynuoen is helping another client following Hainan pathway to get approval. Please do not hesitate to contact us if you need any help.

In February, 2020, NMPA has approved a total of 170 medical devices. 118 of them are domestic Class III medical devices, 16 of them are imported Class III medical devices, 32 of them are imported Class II medical devices and 4 of them are Hongkong, Macao or Taiwan medical device.

On March 24, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from March 3, 2020 to March 16, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction.

On March 20, 2020, NMPA released a notice about collecting comments for amending Medical Device Classification Catalog. Some products are downscaled from Class III to Class II, such as video scope. Relevant comments shall be submitted by April 20, 2020. Bradynuoen can help manufacturers to submit the comments to CMDE.

On March 20, 2020, NMPA released an Administrative Regulations for Expanded Clinical Trials of Medical Devices (Trial) in order to further encourage the innovation of medical devices and support expanded clinical trials of medical devices. The expanded clinical trials of medical devices aim to the patients with life-threatening diseases that do not have effective treatments, and the non-approved medical devices can be used in the clinical trial bases.

On March 17, 2020, NMPA released a Guidelines for Quality Management System Inspection on Medical Device Registration in order to further strengthen the its surveillance on medical device registration. Bradynuoen suggest manufactures to follow the new QMS requirements to do relevant manufacturing and registration. Since China NMPA enhances the registration and product surveillance, Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines.

In order to reduce the risk of infection for doctors fighting against COVID-19, Bradynuoen designed and manufactured the INTUBATION PROTECTIVE SYSTEM based on the inspiration from the front-line doctors in Leishenshan Hospital, Wuhan, China. This device will block the sputtering of droplets and suck out the aerosol by negative pressure for harmlessization.

Considering the vital role of sophisticated medical devices, such as ventilators, ECMO, mobile P3 laboratory and mobile CT in the battle against COVID-19, National Health and Family Planning Commission of PRC is studying to provide a long-term mechanism of medical device reserve. It is a great opportunity for medical device manufacturers to enter China market, due to the constant purchase for long-term reserve in China.

On March 13, 2020, NMPA updated the new regulation: Measures for the Management of Medical Device Quality Audit. Meanwhile, the Administrative Regulations on Quality Supervision and Audit of Medical Devices (食药监械监[2013] No. 212) and the National Medical Device Audit Work Procedure (食药监械监[2014] No. 213) issued by NMPA shall be abolished. The new regulations include seven chapters: general rules, protocols, audit sampling, audit management and report delivery, re-inspection and disposal, surveillance and management, and supplementary provisions. China is enhancing the post-market surveillance since the latest two years. Bradynuoen as a qualified legal agent of overseas manufacturer can help the communication with NMPA, handle AE, recall, inspection etc.