The NMPA released two documents to enhance the dynamic management of medical device classification on June 1, 2026. Issued as “Classification Adjustment Announcement” and the “Working Procedure for Dynamic Adjustment of the Medical Device Classification Directory”, these updates establish a more scientific, transparent, and risk-proportionate system for adjusting product categories, management attributes (medical device vs. […] The post NMPA Refines Medical Device Classification Adjustment Framework with Detailed Interpretation appeared first on China Med Device.

To support the implementation of the IVD Reagent Classification Catalog issued in May 2024, NMPA issued a detailed interpretive guideline specifically for staining solutions. This guidance provides regulatory clarity for foreign manufacturers seeking to register their high-quality staining products in China. For “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” issued in April 2026, […] The post NMPA Official Interpretation Provides Regulatory Clarity for IVD Staining Reagents Classification appeared first on China Med Device.

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies 11 Class III Devices and 66 IVDs to be Newly Exempted from Clinical Trial NMPA published the “Clinical Evaluation Exempt Draft […] The post NMPA Roundup June 2026 appeared first on China Med Device.

NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, taking effect on November 1, 2026. This marks the most substantial update to China’s device manufacturing regulation since the original 2014 version. Since our comprehensive analysis on the new GMP published, there has been some confusion around the status of […] The post China’s Medical Device GMP Overhaul: Transition, Clarifications, and Key Compliance Upgrades appeared first on China Med Device.

NMPA published seven guidelines on post-market surveillance for medical device manufacturers in April 2026. 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. This article provides an […] The post NMPA’s 2026 Post-Market Vigilance Framework: Essential Compliance Guide for Overseas Medical Device Manufacturers appeared first on China Med Device.

The NMPA granted innovation approval to B.Braun Avitum’s CRRT hemofilter and issued a review report. The published review reports like this one serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review […] The post NMPA Review Report Released for B.Braun Avitum’s CRRT Hemofilter appeared first on China Med Device.

NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” on April 30, 2026. Feedbacks need to be submitted by May 29, 2026. It proposes to newly-include 11 Class III medical devices and 66 Class III IVDs into the exemption list. Implementing risk-based clinical […] The post 11 Class III Devices and 66 IVDs to be Newly Exempted from Clinical Trial; Feedback until May 29 appeared first on China Med Device.

NMPA published 5 medical devices final guidelines on April 30, 2026. They are aimed 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. Why Overseas Manufacturers Should […] The post NMPA Clinical Updates: What Overseas Manufacturers Need to Know About the 5 New Class III Devices Guidelines appeared first on China Med Device.

NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices. The revisions are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission. Significance of NMPA Guidelines The guidelines are introduced by NMPA Center of Medical Device […] The post NMPA: 56 Class III Devices impacted by 2026 Guidelines Revisions Plan appeared first on China Med Device.

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies As China Overhauls GMP, KARL STORZ’s High-frequency Surgery System Faces Import Suspension Over QMS Failures The NMPA issued a remote […] The post NMPA Roundup May 2026 appeared first on China Med Device.