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
	Status of use Patterns of 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

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