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 |
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 |