China NMPA Medical Device Classification Determination Guide

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 1

When classification determination applies

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 2

An application for classification determination may be made when a medical device product:

Is not explicitly listed in the current Medical Device Classification Catalogue

Or when the manufacturer disputes or is unsure of the product’s classification

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 3

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 4

Details of the classification determination application process

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 5

Core procedure

1. Application: log in to the platform designated by the National Institutes for Food and Drug Control (NIFDC), complete the application information as required and upload the relevant documents.

2. Supplementary documents: if the reviewing department requests additional information, the company must supplement and resubmit the documents within the prescribed time.

3. Issuance of the classification determination: once the review is passed, the competent authority issues a formal classification determination document specifying the product’s classification.

Processing time

Standard review period: 1–3 months (depending on product complexity)

Time spent supplementing documents does not count towards the formal review period

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 6

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 7

Application document checklist and requirements

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 8

I. Basic application documents

Document	Requirement	Purpose
Medical Device Classification Determination Application Form	Must bear the company seal	Records basic product information and the request
Product overview	Detailed description of the development background and technical approach	Helps the reviewing department understand the product’s characteristics
Product technical requirements	Written in accordance with national standard drafting rules	Core basis for determining the product’s technical attributes

II. Documents demonstrating product characteristics

Visual evidence: photos of the product from multiple angles and step-by-step usage diagrams (resolution of at least 300 dpi)

Demonstration materials: video of the product in use (5–10 minutes recommended, with text explanations)

Instructions for use: the version intended for marketing (including complete safety warnings)

III. Documents describing key attributes

Product name (must comply with the Medical Device Naming Rules)

Intended use (clearly stating the clinical application)

Target population (restrictions such as age and disease state)

Structure and composition (with exploded diagrams of components and a bill of materials)

IV. Conformity documents

Declaration of conformity (declaring compliance with relevant national standards)

Supporting evidence (such as patent certificates and test reports)

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 9

Notes

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 10

Check documents for completeness before submission to avoid review delays due to missing information

Technical parameters described must be consistent with the data in test reports

The validity of the classification determination is linked to the product registration cycle; please manage timelines accordingly

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 11

More articles:

NMPA Announcement on Implementing the 2025 Edition of the Pharmacopoeia of the People’s Republic of China

The Free Sale Certificate (FSC): A “Passport” for Global Medical Device Trade

The “Invisible Guardian” of EU Medical Device Registration: A Complete Guide to Authorized Representatives

A Special Route for E-Cigarettes to Enter the EU Outside the TPD

Introduction to EU MDR Class I Products

Guide to Writing MDR Technical Documentation

Clinical Evaluation Routes and Methods in MDR Certification

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 12

About Us

COMPANY INTRODUCTION

EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 13

Our Offices

COMPANY ADDRESS

Shanghai: Room 705, Building 6, Lane 111, Luxiang Road, Baoshan District, Shanghai | Germany: Landsberger Str. 155, 80687 München, Germany

Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria

Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong

Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 14

Detailed Guide to the Medical Device Classification Determination Procedure – Figure 15