China’s current NMPA medical device classification system has been in place since August 1, 2018, which specifies that “classifications should be based on the Device Category, Subcategory, Example of Device Names, Product Description and Intended Use.”
Overview of Medical Device Classification in China
Compared with the previous catalog system, the key changes are:
- The number of device categories have decreased from 43 to 22.
- 1,157 subcategories have been added.
- Product description and intended use have been added to determine the right classification. Furthermore, the difference between the sterilized device and the non-sterilized device, under the same category and subcategory, are now shown in the product description.
- More examples of device names are provided. The number of device names has increased from 1,008 to 6,609.
- There are 40 reclassifications.
- AI diagnostic is added.
Effective August 1, 2018, the previous classification catalog for Class II and III devices have become obsolete. Class I device classification now relies not only on the new catalog but also on other resources that are currently available. It should also be noted that the new catalog only applies to medical devices. The existing NMPA (CFDA) catalog system continues to work for IVD products. For your questions regarding IVD classifications, please email us at info@ChinaMedDevice.com.
China Medical Device Classes & Categories
Low-risk medical devices whose safety and effectiveness are ensured through routine administration.
Mid-risk medical devices that require further control in order to ensure their safety and effectiveness.
High-risk medical devices that are implanted into the human body, used to support or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness
Overseas Medical Device Registration in China
China Dedical Device Classification Catalog
- Active surgical
- Passive surgical device
- Neuro & cardio surgical device
- Ortho surgical device
- Radiation device
- Imaging device
- Diagnostic & monitoring device
- Anesthesia device
- Physiotherapy device
- Infusion & dialysis devicev
- Sterilization device
- Active implantable device
- Non-active implantable device
- Nursing and protective device
- Bed and transportation device
- Ophthalmic device
- Dental device
- Gynecological and obstetric device
- Rehabilitation device
- Traditional Chinese medical device
- Laboratory device
Advantages of China's 2018 Medical Device Classification System
- The classification structure is a better match to clinical practice
- Additional product key info better identifies and describes each medical device
- Product name examples increase and provide boarder coverage.
NMPA Medical Device Registration & Clinical Trial Process
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