What are the main differences between Class I, Class II, and Class III medical devices? Shared by a Hainan Medical Device Registration Consulting Service Company

I. Medical devices are divided into Class I, Class II, and Class III. The main differences are reflected in the following aspects:

1. Management Level: Class I, Class II, and Class III medical devices are classified according to their safety and risk levels, corresponding to different management levels. Class I medical devices have lower risk, and the manufacturer is responsible for product quality management; Class II medical devices have moderate risk and require approval from the National Medical Products Administration before they can be sold and used; Class III medical devices have higher risk and require a more stringent approval process, under the strict supervision of the National Medical Products Administration.

2. Safety Requirements: Class I medical devices have relatively low safety requirements and are typically non-invasive, non-implantable, and inactive devices, such as thermometers and masks. Class II medical devices have higher safety requirements and are suitable for invasive procedures or implantable surgeries, such as infusion sets and electrocardiographs. Class III medical devices have the highest safety requirements and are suitable for high-risk procedures or implantable surgeries, such as pacemakers and artificial joints.

3. Regulatory Requirements: For Class I medical devices, manufacturers need to conduct their own quality management but also need to register with regulatory authorities. For Class II medical devices, manufacturers need to obtain a product registration certificate from the National Medical Products Administration before they can produce and sell. For Class III medical devices, manufacturers need to conduct more stringent clinical trials and technical reviews and obtain a specific approval number before they can sell and use.

In general, Class I medical devices have lower risk and lower safety requirements, and are subject to relatively lenient regulation; Class II medical devices have moderate risk and moderate safety requirements, and are subject to relatively strict regulation; Class III medical devices have higher risk and higher safety requirements, and are subject to very strict regulation.

II. What are the differences in the numbering system for the three categories of medical devices: Class I, Class II, and Class III?

Medical devices are classified into three risk levels: Class I (low risk), Class II (medium risk), and Class III (high risk). Let's examine the differences between these three categories!

1. Class I Medical Devices:

Class I medical devices are low-risk devices whose safety and effectiveness can be guaranteed through routine management. Examples include: surgical instruments (scalpels, scissors, forceps, tweezers, hooks), scraping boards, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.

The numbering system for Class I medical devices is: A械备BBBBCCCC号

"A" represents the abbreviation of the location. For imported medical devices, it is "国" (Guo). For domestically produced medical devices, it is the abbreviation of the provincial-level administrative region plus the abbreviation of the municipal-level administrative region, such as "粤穗" (Yue Sui) for Guangzhou City, Guangdong Province.

B indicates the year of registration.

C indicates the registration serial number.

For example: National Medical Device Registration No. 20201234

2. Class II Medical Devices:

Class II medical devices are of moderate risk and require strict control and management to ensure their safety and effectiveness. Examples include: medical sutures, blood pressure monitors, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic sterilization equipment, non-absorbable sutures, condoms, etc. (The Four-in-One Intermediate Frequency Therapy Instrument belongs to Class II.)

Cardiac Stents (Class III)

3. Class III Medical Devices:

Class III medical devices are of high risk and require special measures for strict control and management to ensure their safety and effectiveness. Examples include: implantable pacemakers, contact lenses, artificial lenses, ultrasonic tumor focusing knives, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters, etc.

Class II and III medical devices are designated with the following registration number: A械注BCCCCDEEFFFF

A represents the abbreviation of the location; for imported medical devices, it is "国" (Guo); for domestically produced medical devices, it is the abbreviation of the provincial-level administrative region.

B represents the registration form; for imported devices, it is "进" (Jin); for domestically produced devices, it is "准" (Zhun); and for devices from Hong Kong, Macau, and Taiwan, it is "许" (Xu).

C represents the year of initial registration.

D represents the management category; "2" indicates Class II medical devices, and "3" indicates Class III medical devices.

EE represents the classification code; specific classification codes can be found on the website of the National Medical Products Administration.

F represents the initial registration serial number.

For example: National Medical Device Registration Certificate No. 20203401234

III. List of Commonly Used Medical Devices

1. Class I Medical Devices

Basic surgical knives, including scalpel handles and blades, scalpels, wart removal knives, scalpels, spatulas, razors, skin scrapers, picks, sharp knives, pedicure knives, nail trimmers, scalpels, etc.;

General hospital beds, wheelchairs, etc.;

General medical dressings, such as absorbent cotton, gauze bandages, and wound dressings, etc.

2. Class II Medical Devices

(a) General Diagnostic Instruments (6820): Thermometers, Blood Pressure Monitors;

(b) Physical Therapy and Rehabilitation Equipment (6826): Magnetic Therapy Devices;

(c) Clinical Examination and Analysis Instruments (6840): Home Blood Glucose Analyzers and Test Strips;

(d) Operating Room, Emergency Room, and Treatment Room Equipment and Utensils (6854): Portable Medical Oxygen Generators;

(e) Hemostatic and Wound Care Dressings (6864): Hydrocolloid Dressings, Hemostatic Powder, etc.;

(f) Medical Polymer Materials and Products (6866): Condoms, Contraceptive Caps, etc.

3. Class III Medical Devices

A. Single-use sterile medical devices:

1. Single-use sterile syringes;

2. Single-use infusion sets;

3. Single-use blood transfusion sets;

4. Single-use anesthesia puncture kits;

5. Single-use intravenous infusion needles;

6. Single-use sterile injection needles;

7. Single-use plastic blood bags;

8. Single-use blood collection devices;

9. Single-use burette-type infusion sets.

B. Orthopedic implants:

1. Surgical implants, joint prostheses;

2. Bone screws, bone plates, etc.;

C. Single-use sterile medical devices:

1. Eyeglasses and care solutions;

2. In vitro diagnostic reagents;

3. Absorbable hemostatic materials;

4. Injectable sodium hyaluronate and other cosmetic products.

Other surgical devices:

1. Vascular stents and their delivery systems;

2. Artificial blood vessels;

3. Heart valves;

4. Artificial organs, etc.

IV. Introduction to the Issuance of Relevant Certificates for Class I, II, and III Medical Devices

1. Class I Medical Devices - No Medical Device License Required

Class I medical devices are those with low risk levels and whose safety and effectiveness can be guaranteed through routine management, such as scalpels, surgical scissors, manual hospital beds, medical ice packs, and cooling patches. Product and manufacturing activities are subject to filing management by the municipal-level food and drug administration department where the product is located. Business operations are completely open; no license or filing is required, only a business license issued by the industry and commerce department is needed.

2. Class II Medical Devices - Medical Device Business Registration by Municipal Drug Administration/Market Supervision Administration

Class II medical devices are those with moderate risk, requiring strict control and management to ensure their safety and effectiveness. Examples include common everyday items such as adhesive bandages, condoms, thermometers, blood pressure monitors, oxygen concentrators, and nebulizers. Their production and sales activities are subject to licensing management by provincial food and drug administration departments, which issue a "Medical Device Registration Certificate" and a "Medical Device Production License," respectively. Business operations are subject to registration management by the municipal-level food and drug administration departments.

3. Class III Medical Devices - Medical Device License by National Medical Products Administration

Class III medical devices are those with high risk, requiring special measures and strict control and management to ensure their safety and effectiveness. Examples include common infusion sets, syringes, intravenous catheters, cardiac stents, ventilators, CT scanners, and MRI machines. Their production and sales activities are subject to licensing management by the National Medical Products Administration, provincial food and drug administration departments, and municipal food and drug administration departments, which issue a "Medical Device Registration Certificate," a "Medical Device Production License," and a "Medical Device Business License," respectively. The above is the complete content of "What are the main differences between Class I, Class II, and Class III medical devices? Shared by Hainan Nayang Medical Device Registration Consulting Service Company" introduced by Hainan Nayang. If you are interested in related articles, please continue to follow the official website of Hainan Nayang, a professional consulting service provider for Hainan medical devices, including Hainan medical device digital therapy CDMO services, Hainan medical device digital therapy CRO consulting services, Hainan medical device clinical trial CRO consulting services, and Hainan medical device commissioned R&D and manufacturing CDMO services.

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