On April 9, 2020, NMPA announced that 12 medical device industry standards and an amendment have been approved. Details about the standards and amendment is listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines.
China released the results of urgent approved clinical trials of medical devices against COVID-19.
No. | Approval Number | Clinical trial name | Applicant | Approval Date |
1 | 国科遗办审字〔2020〕CJ0004YJ号 | Clinical trial of 2019-nCoV IgM antibody detection reagent (magnetic particle chemiluminescence method) | Zhongnan Hospital of Wuhan University | March, 2020 |
2 | 国科遗办审字〔2020〕CJ0005YJ号 | Clinical trial of 2019-nCoV IgG antibody detection reagent (magnetic particle chemiluminescence method) | Zhongnan Hospital of Wuhan University | March, 2020 |
3 | 国科遗办审字〔2020〕CJ0006YJ号 | Clinical trial of 2019-nCoV antibody detection reagent (colloidal gold method) | Zhongnan Hospital of Wuhan University | March, 2020 |
4 | 国科遗办审字〔2020〕CJ0007YJ号 | To verify the clinical safety and effectiveness of the gene sequencer in the clinical trial of 2019-nCoV nucleic acid detection | The First Affiliate Hospital of GUANGZHOU Medical University | March, 2020 |
5 | 国科遗办审字〔2020〕CJ0008YJ号 | Clinical trial of 2019-nCoV nucleic acid detection reagent (reversible terminal termination sequencing) | The First Affiliate Hospital of GUANGZHOU Medical University | March, 2020 |
6 | 国科遗办审字〔2020〕CJ0009YJ号 | Clinical trial of 2019-nCoV nucleic acid analysis software | The First Affiliate Hospital of GUANGZHOU Medical University | March, 2020 |
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 20, 2020, CMDE released an announcement to approve two innovative medical devices, i.e., “coronary artery blood supply function evaluation software” and “MRI System” from Ruixin Intelligent Medical and Zhongke Jihua respectively. We have helped four innovative medical devices entry China. Please do not hesitate to contact us if you need any help via info@inspirativemed.com
Link: https://www.cmde.org.cn/CL0004/20648.html
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.
This device has been applied in Leishenshan Hospital, Wuhan, China with intended use for various infectious procedures to protect the operators. This product is classified as Class I in China. more…
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.
Link: http://www.nhc.gov.cn/xwzb/webcontroller.do?titleSeq=11252&gecstype=1
In order to encourage artificial intelligence industry, the Ministry of Science and Technology of the People’s Republic of China promotes the establishment of the “New-Generation AI Innovation and Development Pilot Zones” in different areas of China, so as to stimulate the deep integration of artificial intelligence with real economy, and push forward the artificial intelligence technology innovation and industrial development. Up to now, 11 cities/areas have already been approved for the construction of the Pilot Zone. more…