GE Healthcare Finland Oy and Datex-Ohmeda, Inc voluntarily recalled its Patient Monitor and two anesthesia systems due to the breathing module sensor may be invalid. Relevant recall information has been released with Recall Level 2 on November 4, 2019, but now the recall level is changed to Level 1. Recall Level 1 is the most serious case. Since China NMPA enhances the post-market surveillance, Bradynuoen can help manufacturers handle AE and recalls in compliance to China regulations. more…
We often encounter the word “agent” when registering medical devices no matter at home or abroad. What exactly does it mean and what is required of an “agent”?
Here are the relevant requirements for medical device “agents” in Chinese, US and European regulations.
On February 25 and 26, 2020, NMPA announced that 13 new medical device industry standards have been approved as well as a medical device industry standard amendment. 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.
On February 26, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from February 4, 2020 to February 17, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
In January, 2020, NMPA has approved a total of 120 medical devices. 72 of them are domestic Class III medical devices, 27 of them are imported Class III medical devices, 20 of them are imported Class II medical devices and one of them is Taiwan medical device.
Link: http://www.nmpa.gov.cn/WS04/CL21
Please find the approved imported medical devices in Jan., 2020 as below. If you want to know more about your device category, clinical pathways, predicate information and other related to your China business, please do not hesitate to contact us info@chinameddevice.cn.
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Amid the COVID-19 crisis, China NMPA has taken many measures to handle its insufficient medical resources. Along with emergency approval procedures and the importation of non-NMPA approved devices, expect additional reforms to be triggered by this crisis and potential new opportunities for medical device manufacturer to accelerate China registration: more…
Real-world data (RWD) is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings. Real-world data refers to observational data as opposed to data gathered in an experimental setting such as a randomized controlled trial (RCT). more…
In this article we will provide a general introduction about Clinical Evaluation Report (CER) for medical devices registration and application in China. Current regulations in both China and EU require CER for medical device registration. In this article, we will cover the CER document requirements by China’s NMPA (CFDA) as well as differences between EU and China in CER requirements. more…
To help contain the novel Coronavirus (“2019-nCoV”), NMPA issued the Notice of Importing None-NMPA Approved Medical Devices on Jan 27, informing provincial counterparts to allow import none-NMPA approved devices but have FDA approval, CE mark, or Japan approval.
It further specifies that “the provincial NMPA shall cooperate with local departments of Industry and Information Technology, Health and Customs to ensure smooth importation and customs clearance. Provincial NMPA shall issue the Certificate of Import License if needed.”
As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, with focus on protective supplies, sterilization and ventilation devices.
For the three prerequisites for Emergency Approval, and the category of urgently needed medical supplies, please contact us. more…
While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, dozens of essentials detection kits, medical devices and supplies received accelerated regulatory approval.
Thankfully, the outbreak appears to be contained and could be over by April, according to Academician Zhong Nanshan in a February 11 Reuters interview. As the crisis winds down, this incident may have a variety of implications on medical device manufacturers, including lessons for expedited market entry, a greater push for electronic document submission and challenges to ongoing clinical trials. more…
