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 ClassificationMedical Device ClassificationRisk LevelLevel of Agency
Class Isafety and effectiveness can be ensured through routine administrationLowBy the drug regulatory authority of the government of the municipalities
Class IIFurther control is required to ensure their safety and effectivenessMediumBy the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government
Class IIIImplanted 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 effectivenessHighBy the drug regulatory authority directly under the State Council
Premarket Approval Process
Class IClass IIClass 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 useShort-term useLong-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
1Liquid transportation deviceIIIIIIIIIIIIIIIIIIIII
2Blood and other body fluids alternation deviceIIIIIIIII
3Medical dressingIIIIIIIIIIIIIIII
4Invasive deviceIIIIIIIIIIII
5Reusable surgical device||II
6Implantable deviceIIIIIIIII
7Contraceptive and family planning device (excluding reusable surgical device)IIIIIIIIIIIIIIIIIIIIIIII
8Other non-active devicesIIIIIIIIIIIIIIIIIIIII
Active device

Status of use

Patterns of use

Minor injuryModerate injurySerious injury
1Energy treatment deviceIIIIIII
2Diagnostic and monitoring deviceIIIIIII
3Liquid transportation deviceIIIIIII
4Ionizing radiation deviceIIIIIII
5Implantable deviceIIIIIIIII
6Other active devicesIIIIIII

Non-Body-Contacting Device

Non-active device

Status of use

Patterns of use

Little impactMinor impactSignificant impact
1Nursing deviceIII
2Device for medical device sterilization and cleaningIIIII
3Other non-active devicesIIIIII
Active
device

Status of use

Patterns of use

Little impactMinor impactSignificant impact
1Clinical laboratory instrumentsIIIIII
2Stand alone softwareIIIII
3Instruments for medical devices disinfection and sterilizationIIIII
4Other active devicesIIIIII
Need More Information