Policies
China New GSP Takes Effect July 1, 2024
NMPA released “Quality Management Measures for Medical Device Operations” on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsoleted.
The GSP addresses the new trends including automated vending machine, multi-warehouse collaboration, direct shipping operation, warehouse and shipping order, transportation process records and after-sales service, etc. Click HERE for our comprehensive analysis.
GSP On-site Inspection Draft Guideline Issued
NMPA published the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management (Draft)” on June 27, 2024. Feedback needs to be submitted by July 15, 2024.
The draft document deliberates the details of on-site inspection requirements in tabular forms, including QMS establishment and improvement, responsibilities and systems, key positions and duties, quality records and documentation, personnel and training requirements.
For our article on the GSP on-site inspection draft guideline, please click HERE
Checkpoints Reveal How NMPA Inspects Your Clinical Trial
NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” for feedback. It proposed regulations on on-site inspection key issues of clinical trial, including institutional requirements, device and facility Standards, researcher qualifications, contracts and documentation, ethical review, informed consent, protocol deviations, data integrity, records and data storage etc.
For our comprehensive analysis please click HERE.
Guidelines & Standards
List of Medical Device Mandatory Standards Released
NMPA issued the “List of Mandatory Standards Applicable to Medical Devices” on June 13, 2024. Over 400 mandatory national and industry standards are included, such as laser surgery equipment, high-frequency surgical equipment, radio frequency ablation equipment, argon coagulation equipment, electrodes and catheters for high frequency/radio frequency, perfusion pumps for RF ablation equipment, etc.
Click HERE for the full list of mandatory standards.
Fast-Track Approvals
Review Report Released for Roche’s Vitamin K Antagonist Self-Test
The NMPA granted Class II approvals to Roche’s Vitamin K Antagonist Self-Test, the combination of CoaguChek INRange and CoaguChek XS PT Test PST, and issued two review reports. Please click HERE for review report of the IVD part.
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.
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- Source: https://chinameddevice.com/nmpa-july-2024/