According to “Regulations for the Supervision and Administration of Medical Devices”: medical device 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 based on:

Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;

Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness

Class III Medical Devices are those 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.

The classification catalogue for medical devices shall be stipulated, adjusted and promulgated by the drug regulatory authority under the State Council, in accordance with classification principles after consulting with health authority under the State Council.

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