In China, medical device classifications are determined based on multiple factors, including the duration of use, the place where the device contacts the human body, the degree of influence on medical effect, the degree of injury caused by losing control of the device, and the degree of influence on medical effect.

Terms

To determine the classification of medical devices correctly, applicants need to know the relevant definitions:

1. Intended Purpose

Intended purpose is the effect that the medical device should achieve as indicated in the package insert, label, or brochure.

2. Non-active Medical Device

Non-active medical device refers to any medical device whose purpose is achieved by energy generated by human body or gravity, instead of electric power or any other power.

3. Active Medical Device

Active medical device refers to any medical device whose purpose is achieved by electric power or other power, instead of energy generated by human body or gravity.

4. Invasive Device

Invasive device means any device, in whole or in part, that penetrates into the human body through the body surface to contact with the tissues inside the body, blood circulatory system, central nervous system and other parts of the body.

Such devices include the instruments used in surgical interventions, disposable non-sterile surgical instruments, and devices staying inside the human body transiently (less than 24 hours) or for a short term (more than 24 hours but less than 30 days).

Invasive devices do NOT include reusable surgical instruments (as the latter do not stay inside the human body).

5. Reusable Surgical Instrument

Reusable surgical instrument belongs to non-active medical device that are intended for surgical use in cutting, drilling, sawing, scratching, scraping, vising, retracting, clamping and other procedures, without connecting to any active device, and can be reused after appropriate procedures.

6. Implantable Device

Implantable device is any device that

—is partially or entirely placed into human body or orifice via surgery, or

—is used to replace an epithelial surface or eye surface via surgery, and remain in place inside the human body for at least 30 days or absorbed after the procedure.

7. Device Contacting with the Body

Any medical device that directly or indirectly contacts with the patients, or can be used to enter the patient’s body.

8. Duration of Use

 8.1 Duration of continuous use: the duration of the medical device being used for the intended purpose without interruption.

8.2. Transient use: intended for continuous use for less than 24 hours.

  8.3. Short-term use: intended for continuous use for more than 24 hours but less than 30 days.

8.4. Long-term use: intended for continuous use for at least 30 days.

9. Skin

The surface of intact skin.

10. Orifice

Natural opening in the human body, including oral cavity, nasal cavity, esophagus, external auditory canal, rectum, vagina, and urethra, as well as any permanent artificial opening.

11. Wound

Damage to the integrity or dysfunction of the body tissue structure caused by any injury.

12. Tissue

Tissues in the human body, including bone, pulp and dentin, excluding the blood circulatory system and central nervous system.

13. Blood Circulatory System

Blood vessels (except capillaries) and the heart.

14. Central Nervous System

Brain and spine.

15. Independent Software

Software with one or more medical purposes running on a general-purpose computing platform that can accomplish its intended purpose without medical device hardware.

16. Medical Device with Measuring and Testing Functions

Medical device used to measure physiological, pathological, and anatomical parameters, or quantitatively measure energy or substances delivered to or removed from the human body when the measurement results need to be accurately quantified, and the accuracy of the results will impact the patients’ health and safety.

17. Chronic wounds

Long-term non-healing wounds formed by any reasons, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers, pressure ulcers, etc.

Classification

According to China’s Medical Device Classification Rules effective since Jan. 1, 2016, medical devices are divided into Class I, Class II, and Class III with risk levels rising in sequential order. The risk level is determined based on the device’s intended purpose with various other factors, including structure characteristics, the form of use, the status of use, whether the device contacting the body, etc.

Medical Device Risk Level: Class I < Class II < Class III

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