Policies
New China Device GMP Regulations: Key Changes and Industry Impact
NMPA published the new draft “Medical Device Manufacturing Quality Management Standards”. The proposed standards require enterprise digitalization systems to ensure regulatory compliance and data integrity. It mandates risk-based validation for critical facilities, equipment, and processes. The draft also details validation requirements and the need for a master validation plan. Contract manufacturing regulations ensure comprehensive quality management and effective communication. Click HERE for the detailed changes.
Guidelines & Standards
85 NMPA Standards to be Revised in 2025: By Indications
NMPA issued the “2025 Medical Device Industry Standards Revisions Plan” on February 24, 2025. Six mandatory and seventy-nine recommended standards will be revised or established.
The 85 standards cover medical fields like anesthesiology, cardiovascular, dentistry, and more. They specify requirements for devices such as implants, radiology equipment, and diagnostics, ensuring safety and efficacy. For the full list categorized by indications, please click HERE
139 Standards Issued in 2024, Elevating Medical Device Regulations to Global Excellence
The NMPA released 49 national standards and 90 industry standards for medical devices and in vitro diagnostics (IVDs) in 2024. These standards were revised or newly established to assist manufacturers in local type testing, clinical evaluation, and regulatory submissions, etc. Click HERE for the list of national and industry standards
Fast-Track Approvals
NMPA Review Report Released for MediBeacon’s TGFR System
The NMPA granted innovation approvals to MediBeacon Inc.’s transdermal GFR measurement system (TGFR).
The product consists of a main unit, a sensor, and a fixation patch. It is used in conjunction with the company’s Remapizine injection, primarily for assessing patients’ glomerular filtration rate (GFR).
This product utilizes a non-invasive fluorescence tracer measurement method with diffuse reflectance correction and background separation correction. By obtaining time-varying optical fluorescence signal attenuation data from the skin surface, it enables continuous GFR measurement. It offers advantages such as ease of use, non-invasiveness, speed, accuracy, and repeatability, benefiting more patients in clinical diagnosis and treatment who require renal function monitoring. Click HERE to read the NMPA review report.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides 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 you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.