Policies
11 Class III Devices and 66 IVDs to be Newly Exempted from Clinical Trial
NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” for feedbacks. It proposes to newly-include 11 Class III medical devices and 66 Class III IVDs into the exemption list. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
For the list of Class III devices and IVDs in the draft catalog, please click HERE
NMPA’s Post-Market Vigilance Framework: Essential Compliance Guide for Overseas Medical Device Manufacturers
NMPA published seven guidelines on post-market surveillance for medical device manufacturers. These documents establish a mandatory, risk‑based vigilance system under the Medical Device Vigilance Quality Management Standards (Trial), supported by detailed implementation guides for trend reporting, periodic safety update reports (PSURs), risk evaluation, vigilance planning, and inspection checkpoints.
For our comprehensive analysis on the seven guidelines, click HERE
Guidelines & Standards
56 Class III Devices impacted by 2026 Guidelines Revisions Plan
NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices.
The scope for the Class III devices is broad, including high-risk devices such as implantable neurostimulation electrodes, artificial vascular grafts, left ventricular assist systems, and other cardiovascular and neuromodulation devices; oncological treatment equipment such as picosecond Nd:YAG laser therapy systems and femtosecond laser systems; interventional consumables such as embolic microspheres and intracranial liquid embolic devices; recombinant collagen products for plastic surgery; and various IVD reagents (e.g., HIV self-test kits, cervical cancer methylation test kits, high-throughput sequencing tumor gene test kits, etc.)
Click HERE for the devices list categorized by indications
Five Class III Devices Clinical Guidelines Issued
NMPA published 5 medical devices final guidelines, aiming to facilitate manufacturers with clarity in clinical evaluation requirements. All five guidance documents are directed at Class III devices, which is the fundamental reason why the NMPA imposes strict requirements on clinical trials or same-type clinical evaluations. Click HERE for more information
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.