Amid the novel Coronavirus (COVID-19) outbreak, we deliver the Coronavirus Special Roundup to give you insights on the measures China NMPA has taken to handle its insufficient medical resources and accelerate Emergency Approval. Forward this newsletter to a colleague and opt-in here.
Two Major Guidelines Published for Coronavirus Diagnostics
NMPA issued the Guideline on Coronavirus Nucleic Acid Detection Reagent and Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent, addressing the urgent needs of virus diagnostics.
The two guidelines cover the eight parts respectively: Application Scope, Performance Evaluation, Type Testing, Determination of Positive Test Results, Main Raw Materials, Production Processes and Reaction Systems, Stability study data and Clinical Evidence.
As of March 1, National NMPA granted 14 Emergency Approvals to diagnostics including 10 employing the nucleic acid method and 4 utilizing antibodies. Among them, it only took 4 days for the first four reagents to go to market.
For the summary of the Guideline on Coronavirus Nucleic Acid Detection Reagent, please click HERE;
For Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent, click HERE.
Urgent Device Needs for Coronavirus Identified
One-hundred categories of medical devices, with focuses on diagnostics, protective supplies, sterilization, ventilation, and ICU care, have been identified by the China Medical Equipment Association. The group issued three batch of “Urgently Needed Medical Devices Index for Novel Coronavirus Prevention and Treatment”, listing specific device names and models, manufacturers, origin countries and models.
Around one-third of the devices listed in the Index are produced by manufacturers outside of China. Read full article
How to Get Emergency Approval Via Provincial NMPA?
Back in January, the national NMPA authorized the provincial counterparts’ import of non-NMPA approved medical devices to combat COVID-19, provided that the devices met certain standards. China Med Device called Beijing NMPA on provincial Emergency Approval, asking the procedure
As of approval, the device usage after the infection period, and if the devices are still needed given that the outbreak is contained in some areas of the country. Read Full Article
NMPA Changes Amid Coronavirus Outbreak
Along with emergency approval procedures and the importation of non-NMPA approved devices, foreign manufacturers shall expect additional reforms, such as expedited use of E-submission and changed clinical trial process, to be triggered by this crisis and potential new opportunities to accelerate China registration. Read Full Article
First Unapproved Cosmetic Device Enters Hainan
Unapproved but urgently-needed medical devices can be used in Hainan province, the China State Council announced in April 2018. As of September 16, 271 medical devices went through the special pathway to be clinically used in Hainan, according to the State Council Information Office news briefing.
A focused ultrasound stimulator, an FDA-cleared, non-invasive procedure, became the first aesthetic device to benefit from the Hainan policy. Read Full Article
23 Evaluation Reports Guide Manufacturers for Market Entry
NMPA CMDE (Center for Medical Device Evaluation) published Registration 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.
The Evaluation Reports, ranging from 20 to 60 pages, contain the information including device description, summary of pre-clinical research, summary of clinical research, IFU analysis and risk-benefit analysis.
The 23 innovative devices, produced by domestic and overseas manufacturers, covering a range of indications, such as cardio-pulmonary, oncology, neurology, orthopedic and immunology. Read Full Article
Two Domestic IVD Companies Obtained Innovation Approval
NMPA granted Innovation Approvals for the Pre-implantation chromosome aneuploidy detection kit, by Suzhou Beikang, and the Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 gene mutation detection kit, by Xiamen Feishuo.
For NMPA comments about the two Innovation Approvals, please Read Full Article.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.