Here’s the latest regulatory news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here.
How to Get Approval for Coronavirus AI Imaging Software
NMPA published the Review Points of CT Image-Assisted Triage and Evaluation Software for Coronavirus (COVID-19)-Infected Pneumonia on March 5, 2020. The document provides guidance to AI software manufacturers on the application scope, basic requirements, risk management, software research, clinical research, instructions and software renewal.
For four takeaways to register Coronavirus AI Imaging Software, please read full article
Claim Products Domestic-Made with Much Simpler Re-registration Process in China
NMPA published the Draft Document of Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing on March 5, 2020. The announcement encourages foreign manufacturers to localize their approved devices in China. This allows foreign-made products to quickly become China-made and commercialize on the Chinese market a lot simpler and faster. As hospital public tenders encourage more domestic made products, this new NMPA announcement will make product transfer from overseas manufacturing site to China manufacturing site faster and simpler.
For the prerequisite and highlights of the policy, please read full article
More Access to Increase Patient Samples in Clinical Trial
NMPA and National Health Commission jointly issued the Administrative Measures of Medical Device Expanded Access for Clinical Trial on March 20. The document, intended to get clinical trials for patients who are in life-threatening conditions without effective treatment, sets forth the requirements of rights and responsibilities, initiation scenarios, process management, data collection. Read full article
Standards Revisions to Help Type Testing and Registration
NMPA issued the 2020 Medical Device Industry Standards Revisions Plan on March 20, in which 86 medical devices and IVDs are affected. Among them are nine mandatory standards and 77 recommended ones.
Click HERE to see how mandatory standards differ from recommended ones, and the implications for the plan.
Unprecedented Number of Guidelines and Standards in March
Despite the global outbreak of novel coronavirus (COVID-19), NMPA published 16 guidelines and 43 standards in March, guiding manufacturers with type testing and registration.
Among them are Principle of Safety and Efficacy of Medical Device, and regulations concerning specific plastic surgery, cardiovascular and imaging equipment and IVD reagents. Read full list here
Cardio Software and Imaging System Went into Innovation Pathway
Two domestic manufacturers were granted Innovation Status in March:
- Shenzhen Ruixin: Coronary artery blood supply function evaluation software
- Wuhan Zhongke Jihua: MRI imaging system
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 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 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.