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 a Rapidly Searchable Classification Catalogue, providing a comprehensive, structured, and practical reference for manufacturers navigating China’s increasingly refined medical device regulatory system. Covering thousands of device entries, the Excel-based catalogue consolidates official classification information released by NMPA and presents it in a format that is optimized for fast retrieval, comparison, and decision-making.
For the Rapidly Searchable Classification Catalogue, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For the 2017 classification catalog, please click HERE
For the latest changes on the catalog, click HERE
For the renewed classification rules, click HERE
Overall Structure and Scope of the Catalogue
The catalogue is organized according to China’s 2027 classification framework and includes:
- Primary product categories (Level I), such as active surgical instruments, passive implants, in vitro diagnostic devices, medical imaging equipment, and rehabilitation devices
- Secondary product categories (Level II) that further refine device functions, use scenarios, and technical characteristics
- Product descriptions summarizing intended use, working principles, and core components
- Regulatory classification levels, indicating whether a product is regulated as Class I, II, or III
- Regulatory references and links, including classification determination notices, historical decisions, and official regulatory texts
- Annotations and highlights, where color coding is used to flag classification determinations, classification adjustments, or special regulatory notes
With more than 6,000 rows of data, the catalogue reflects both the breadth of China’s medical device ecosystem and the granularity of regulatory expectations.
Emphasis on Classification Determination and Regulatory Evolution
One of the most valuable features of this catalogue is its systematic inclusion of classification determination results. These entries reflect official regulatory interpretations issued when a product’s classification was unclear or disputed. Such determinations are critical in practice, as they often dictate:
- Whether a device requires clinical evaluation or full clinical trials
- The applicable registration pathway and review authority
- Timelines, costs, and documentation requirements
The catalogue also highlights classification adjustments, indicating areas where regulatory thinking has evolved over time. This is particularly important for innovative devices, combination products, and technologies imported from overseas markets, where assumptions based on U.S. FDA or EU MDR classifications may not directly translate to China.
By integrating historical and recent classification outcomes, the document allows users to identify regulatory trends and anticipate how new products may be treated.
Practical Value for Regulatory Strategy and Lifecycle Management
Beyond being a static reference list, the catalogue functions as a decision-support tool. Users can quickly assess:
- Whether a product has precedents in China
- How similar products have been classified
- What regulatory risks may arise due to ambiguity or past reclassification
This is especially useful during early-stage feasibility analysis, licensing negotiations, or investment due diligence. A seemingly minor difference in classification—such as Class II versus Class III—can significantly affect development timelines, budget allocation, clinical requirements, and commercialization strategies.
For overseas manufacturers entering the Chinese market, the catalogue helps bridge regulatory knowledge gaps and reduces the risk of costly misclassification.
Based on the practical needs revealed by such classification data, China Med Device, LLC will be able to deliver a comprehensive, execution-oriented services across the medical device lifecycle.
What We Provide
China Med Device, LLC focuses on comprehensive medical device services, including:
- project feasibility and risk assessment
helping you evaluate regulatory risks, determine whether a project can move forward, estimate timelines and costs, identify potential obstacles, and design optimal regulatory submission pathways);
- establishment of domestic and international medical systems
with successful regulatory inspections and assessments as the ultimate goal;
- medical device project advancement under the PMBP model
we act as your project manager and drive execution using your defined objectives as the final acceptance criteria);
- medical device clinical trials
including scientific and exploratory clinical studies, support for investigator-initiated trials [IITs], GCP-compliant clinical trials, protocol development, and data management;
- medical device registration and certification support
assisting you throughout the regulatory approval and licensing process;
- precision marketing support for medical devices
building practical bridges between major hospitals and distribution channels in China, with clearly defined points of contact. For inquiries or further information, please contact info@ChinaMedDevice.com.