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Classification Rules for Medical Devices

The National Medical Device Classification Catalogue (NMDCC — 医疗器械分类目录) is the primary tool for classifying medical devices in China. Published by NMPA and updated periodically, it lists device categories by product type, with each category assigned a Class (I, II, or III) and a product code.

How the NMDCC is structured​

The NMDCC organises devices into 22 major sub-categories (子目录), each covering a broad product area (e.g. cardiovascular, orthopaedic, diagnostic imaging, IVD). Within each sub-category, specific product types are listed with:

  • Product classification name (产品分类名称)
  • Product code (产品类代号)
  • Class (管理类别: I, II, or III)
  • Description (品名举例 — example product names)

Using the NMDCC​

  1. Identify the sub-category most relevant to your device's intended use and technology
  2. Find the specific product type that best describes your device
  3. Note the class assigned to that product type
  4. Check for updates — NMPA issues adjustments to the NMDCC by announcement; always verify the current version

If your device does not clearly fit an existing entry, seek a classification determination (分类界定) from NMPA.

Key classification principles​

  • Intended use is the primary driver. A product classified as Class I for one intended use may be Class III for another.
  • Technology risk matters — active, implantable, and sterile devices are generally classified higher.
  • Combination products may be classified as a device or drug depending on primary mode of action. See Combination Products.

Official NMDCC resource​

The current NMDCC is published on the NMPA website. NMPA also operates an online classification query system accessible at www.nmpa.gov.cn.

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.