Policies
MRI Draft Clinical Evaluation Guideline Released
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging (MRI) System Comparing the Similar Device (draft)” on August 13, 2020.
The guideline says the differences between the device and the predicates shall be provided to demonstrate that the safety and effectiveness of the declared product are not impacted. The non-clinical data, such as laboratory data (e.g. module test) and, if necessary, human image samples shall be provided to confirm the effect of differentiation on image quality to the predicates. Click HERE for full article
China UDI Database Launched: 97,258 Device Identifiers Already Uploaded
NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take effect on October 1, 2020.
The UDI Database page includes the filing entrance, UDI regulations, database operations manual, Q&A, etc. For UDI regulations, first group of UDI devices and the timeline, please click HERE.
NMPA Q&A on IVD equipment and hemodialyzer
NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues. Click HERE for full article
Guidelines
NMPA published seven pathology and clinical chemistry guidelines in August, to direct manufacturers for clinical trial, local type testing and regulatory approval. See all guidelines in August HERE.
Fast-Track Approvals
Two AI Software Approved for Diabetic Retinopathy
NMPA granted Innovation Approvals of two diabetic retinopathy (DR) assistant diagnosis software, to Shenzhen Guiji and Shanghai Yingtong. It is the first time that AI technology is used in ophthalmology diagnosis. For our comprehensive review on the technology involved and the AI guidelines, please click HERE.
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. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.