Guidelines & Standards
Clinical Guideline Issued for AI Detection Software
NMPA released the “Clinical Evaluation Guideline on Artificial Intelligence-assisted Detection Medical Devices (Software)” on November 7, 2023.
AI-assisted detection devices refer to computer-based AI algorithms that can include functions such as pattern recognition and data analysis. They can be standalone software or embedded software. They are Class III devices. Common examples include those for the detection of lesions or anomalies related to lung nodules, breast nodules, fractures, vascular narrowing, colon polyps.
This document mainly describes the Clinical Trial Design, Non-diagnostic Functions, IFU related to Clinical Evaluation
The guideline also gives colon polyps electronic endoscopic image-assisted detection products and pulmonary nodule CT image-assisted detection products as clinical evaluation examples as an annex. Click HERE for our comprehensive review.
Eighteen Standards Issued in One Day
Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. It includes four mandatory standards, on hemodialysis liquids, polymer-based dental restorative materials, titanium and titanium alloy dental implants, surgical masks, and polymer-based restorative materials.
For the complete list, please click HERE.
Innovation Approvals
NMPA Review Report Released for Varian’s Proton Therapy System
The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. As NMPA standardizes and streamlines the review process for fast-track approval, it is vital for manufacturers to comply with requirements of pre-clinical, clinical trial, and risk-benefit assessment if you have similar equipment entering China market.
Click HERE for our comprehensive analysis.
Two Additive Manufactured Devices Gain Innovation Approvals
The NMPA granted Innovation Approval to five medical devices in November 2023, including two additive manufactured devices. For more information click HERE.
Manufacturing & QMS
Three Imported Contact Lens Found Defects in Inspection
NMPA conducted quality inspection on eleven types of medical devices and released the result on November 14, 2023. Twenty manufacturers are found incompliance, including three overseas companies making soft contact lens. For more information please visit 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, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, 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.
