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Search Results for: Medical Device Classification Catalog

NMPA Proposes Updates to Medical Device Classification Catalog

The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7, 2025. Feedbacks need to be submitted by September 10, 2025. The document demonstrates NMPA’s commitment to improve regulatory clarity and align the risk-proportionate oversight with global regulatory best practices. For the medical device classification catalog,

CFDA New Medical Device Classification Catalogue Effective August 1st, 2018

CFDA Medical Device Classification Catalog draft was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the new classifications. After the release of the initial Catalog in 2002, CFDA has made several modifications to standardize the classification and streamline the registration process. The new Catalog is the

CFDA announced the new “Medical Device Classification Catalogue”!

On August 31, CFDA announced the new “Medical Device Classification Catalogue”. This new catalogue will be implemented on August 1ST, 2018. The revised medical device classification directory has significant implications for medical devices registrations or renewals. It is more robust and comprehensive as compared to its 2002 classificaiton version. We have summarized below the key points, revision background and comparision with the

NMPA Sets Classification and Naming Standards for BCI Medical Devices, with Class II Exception for Non‑AI Stroke Rehab

The NMPA issued “Guideline on Product Classification of Brain-Computer Interface (BCI) Medical Devices” and “Guideline on Nomenclature of BCI Medical Devices” on June 30, 2026. These documents apply exclusively to active medical devices that measure neural signals from the central nervous system (CNS) via invasive or non-invasive means, decode them in real time, and enable bidirectional interaction or closed-loop feedback

NMPA Refines Medical Device Classification Adjustment Framework with Detailed Interpretation

On June 1, 2026, the NMPA released two documents that strengthen its dynamic medical device classification system. The first is the “Classification Adjustment Announcement.” The second is the “Working Procedure for Dynamic Adjustment of the Medical Device Classification Directory.” Together, they establish a clearer, more scientific, and risk-based approach to adjusting product categories, management attributes, and risk classes. In practice,

NMPA Refines Medical Device Classification Adjustment Framework with Detailed Interpretation

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. non-medical device), and risk classes.

NMPA Official Interpretation Provides Regulatory Clarity for IVD Staining Reagents Classification

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, please click HERE China cuts

NMPA Down-Classified Delivery Guide Devices and Certain Inner Ear Prostheses

The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification Catalog” on January 4, 2026. The adjustments are aimed to keep up with the international recognized requirements and further lessen the manufacturers’ regulatory burden. For updates to Medical Device Classification Catalog in 2025, click HERE For the latest NMPA classification results, click HERE Full List

NMPA Device Classification: A Rapidly Searchable and Updated Catalogue Available Now

Accurate medical device classification is the foundation of regulatory compliance, registration strategy, clinical planning, and market access in China. NMPA Classification Catalog was published in August 2017. After the release, several modifications have been made and many classification results have been issued reflect the latest technology and regulatory changes. China Med Device, LLC has consolidated the catalogs and results to

Shanghai Issues New Rules for Transferring Registered Medical Devices into Local Production

The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” on August 14, 2025. The regulation will take effect on October 1, 2025. This marks a significant step in aligning Shanghai’s local regulatory framework with national policy, and in facilitating the localization of already registered medical devices. Guangdong province has

Insights from the 2024–2025 Classification Results: Opportunities for Imported Combination Products Entering China

NMPA Center for Medical Device Standardization Administration released “Drug-Device Combination Products Classification Results (June 2024 to May 2025) on July 7. The document identifies 7 drug-led combination products and 46 device-led combination products. For combination products classification procedure, please click HERE For our white paper on combination products, click HERE Classification Results of Imported Combination Products Several imported products have

NMPA Classifies Non-Laser Light Source Device for Myopia and Amblyopia as Class II Device

NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline offers regulatory clarity for market entry of ophthalmic devices that use light to manage myopia or treat amblyopia. For international manufacturers, this marks a key opportunity to align with Chinese regulations and meet rising demand

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