Classification of medical devices
|
Classification |
Definition |
Administration |
Procedure to follow |
Clinical Trials |
Validity |
|
|
Domestic Devices |
Imported Devices |
|||||
|
Class 1 |
Medical devices for which the safety and effectiveness can be ensured through routine administration |
Municipal Level |
National Level |
Filing |
Not required |
Permanent |
|
Class II |
Medical devices for which further control is required to ensure their safety and effectiveness |
Provincial Level |
Registration |
partly Required |
5 Years |
|
|
Class III |
Medical devices which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness |
National Level |
Registration |
partly Required |
5 Years |
|
For detailed classification methods please refer to:
Measures for the Administration of Medical Device Registration
Medical device classification rules (CFDA decree no. 15)
Class I MDs directory:
CFDA circular about the issue of class I MD directory (No. 8)
Medical
device catalogue (Version 2002)
Classification
Inquiry
If
you need to accurately determine the classification of your products or want to
know more about classification rules, please contact us via:
Tel: 86-10-64187881
Email: service@qiminer.com