China Medical Device Classifications for Marketing Authorization

To acquire China National Medical Products Administration (NMPA)’s marketing authorization for medical devices, companies need to file or register the devices under certain classifications.

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 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

Based on the risk factors, medical devices follow the classification rules below:

As shown in the above table, medical devices are classified into four categories:

   1. Non-active body-contacting device: liquid-conveying devices, devices that alter blood and body fluids, medical dressings, invasive devices, reusable surgical devices, implantable devices, contraceptive and family-planning devices, and other non-active devices that contact with the human body.

   2. Non-active non-contacting device: nursing equipment, equipment for cleaning and disinfecting medical devices, and other non-active non-contacting devices.

   3. Active body-contacting device: energy therapy devices, diagnostic & monitoring devices, liquid-conveying devices, ionizing radiation devices, implantable devices, and other active devices that contact the human body.

   4. Active non-contacting device: clinical testing equipment, hardware-independent software, devices for sterilizing medical devices, and other active devices that do not contact with the human body.

Based on structure characteristics, whether contacting with the human body, and the form of use, the status of use and effect of medical devices includes the following scenarios:

Annex

Medical device classification should comply with the Annex to the Medical Device Classification Rules: Table for Determining Medical Device Classifications.

Notes: “I”, “II”, and “III” refer to class I, class II, and III medical devices.“-”means there is no such situation.

Explanation of Extra Rules

The following are extra rules for certain devices:　

(1) If two or more classifications apply to the same medical device, the classification with the highest risk level shall prevail; for medical device package composed of multiple medical devices, the package’s classification shall be consistent with the highest risk level of the medical devices inside.

(2) For medical devices that can be used as accessories, the classification shall be considered comprehensively with the accessory’s influence on the safety and effectiveness of the parent medical device; if the accessory has a significant influence on the parent medical device, the classification of the accessory should not be lower than that of the parent medical device. 

(3) The classification of medical devices that monitor or affect the main functions of other medical devices shall be consistent with the classification of the monitored and affected devices. 

(4) Drug-device combination products mainly functioning as medical devices shall be administered as Class III medical devices.

(5) Medical devices that can be absorbed by the human body shall be administered as Class III medical devices.

(6) Active body-contacting devices that have a significant influence on medical effects shall be administered as Class III medical devices.

(7) Medical dressings shall be administered as Class III medical devices if they have any of the following conditions:

   — they are expected to have the function of preventing tissue or organ adhesion;

   — they are used as artificial skin to contact wounds in the deep layer of dermis or deeper;

   — they are used for chronic wounds;

   — they can be fully or partially absorbed by the body.

(8) The classification of sterilized medical devices shall not be lower than Class II.

(9) For orthopedic devices that actively exert continuous force on the human body through pulling, stretching, twisting, pressing, bending, etc., and their positionings to the limbs can be adjusted, the classification shall not be lower than Class II.

Excluding the following medical devices:

   — that only have fixing and supporting functions;

   — that are only for temporary orthopedics during surgery;

   — that are for limbs orthopedics after surgery or other treatments.

(10) The classification of medical devices with measuring and testing functions shall not be lower than Class II. 

(11) If the intended purpose of a medical device is the treatment of a specific disease, its classification shall not be lower than Class II. 

(12) Non-active reusable surgical instruments for completing operations under the endoscope, such as grasping/cutting tissue, or removing stones, shall be administered as Class II medical devices.

Resources

• Medical Device Registration and Filing in China

• China Launches Medical Device Master File System

• China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials

• China Announces New Classifications of Medical Sodium Hyaluronate Products

• IVD Reagent Registration and Filing in China

Contact BaiPharm if you’d like to know more about medical device or drug regulations in China.