China Medical Device Regulations

Agency
All medical devices are regulated by China Food and Drug Administration (CFDA)
Medical Device Definition
"Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives: 1. Diagnosis, prevention, monitoring, treatment or alleviation of disease; 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions; 3. Investigation, replacement or modification for anatomy or a physiological process; 4. Control of conception
Classification of Medical Device
International Classification Medical Device Classification Risk Level Level of Agency
Class I safety and effectiveness can be ensured through routine administration Low By the drug regulatory authority of the government of the municipalities
Class II Further control is required to ensure their safety and effectiveness Medium By the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government
Class III 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 High By the drug regulatory authority directly under the State Council
Premarket Approval Process
Class I Class II Class III
Approval by CFDA
Application for approval
Format Inspection by CFDA Administrative Service Center acceptance upon compliance
Technical Review by Center for Medical Device Evaluation (CMDE) within 60 days
Review and decision by CFDA within 30 days
Decision Delivery by CFDA within 10 days
Notes
  • Medical device registration certificate is valid for four years
  • All document should be written in simplified Chinese
  • Clinical evaluation must be conducted for Class II and Class III medical devices before they are put into production

Source: Regulations for the Supervision and Administration of Medical Devices CFDA site (http://eng.sfda.gov.cn/WS03/CL0767/61641.html)

Appendix 1. Table for Determination of Medical Device Classification

 

Body-Contacting Device
Non-active device  

Status of use

Patterns of use

Temporary use Short-term use Long-term use
Skin
/Orifice
(openings)
Trauma
/Tissue
Blood circulation
/Central
Skin
/Orifice
(openings)
Trauma
/Tissue
Blood circulation
/ Central
Skin
/Orifice
(openings)
Trauma
/Tissue
Blood circulation
/ Central
1 Liquid transportation device II II III II II III II II III
2 Blood and other body fluids alternation device III III III
3 Medical dressing I II II I II II III III
4 Invasive device I II III I II III
5 Reusable surgical device | | II
6 Implantable device III III III
7 Contraceptive and family planning device (excluding reusable surgical device) II II III II III III III III III
8 Other non-active devices I II III II II III II III III
Active device

Status of use

Patterns of use

Minor injury Moderate injury Serious injury
1 Energy treatment device II II III
2 Diagnostic and monitoring device II II III
3 Liquid transportation device II II III
4 Ionizing radiation device II II III
5 Implantable device III III III
6 Other active devices II II III

Non-Body-Contacting Device

Non-active device

Status of use

Patterns of use

Little impact Minor impact Significant impact
1 Nursing device I II
2 Device for medical device sterilization and cleaning II III
3 Other non-active devices I II III
Active
device

Status of use

Patterns of use

Little impact Minor impact Significant impact
1 Clinical laboratory instruments I II III
2 Stand alone software II III
3 Instruments for medical devices disinfection and sterilization II III
4 Other active devices I II III