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…
NMPA CMDE (Center for Medical Device Evaluation) published Evaluation Reports for 23 innovative devices in 2019, aiding manufacturers on the vital points to obtain market approval, while committing itself for greater transparency and efficiency. more…
NMPA announced seven recalls in January 2020:
For causes and model numbers of the recalls in January, please email info@inspirativemed.com
For Decree 29 Measures for the Administration of Medical Device Recall, please email us also. We charge nominal fees for the translation.
China has accelerated the Emergency Approvals under the threat of Novel Coronavirus (“2019-nCoV”). National NMPA granted seven Emergency Approvals to Coronavirus Nucleic Acid Detection Reagent manufacturers in January, while provincial NMPA offices paid all-out efforts to help contain the virus. more…
From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu provincial NMPA issued the Test Report for the First Novel Coronavirus Nucleic Acid Detection Kit, describing the procedure of expedited regulatory process in the coronavirus pandemic: more…
NMPA (CFDA) published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. The draft guideline was issued on August 14, 2018. more…
