Classification of the Core Framework for Global Regulation of Medical Devices

1、 China: Risk Classification System for Categories I, II, and III

According to the "Regulations on the Supervision and Administration of Medical Devices" and the "Classification Rules for Medical Devices", China classifies them into Class I, Class II, and Class III based on their risk from low to high. The specific classification rules are as follows:

Class I (Low Risk)

Judgment criteria: Devices that can ensure safety and effectiveness through routine management are usually non-invasive, have a short contact time, or only come into contact with intact skin

Typical products: medical examination gloves, gauze bandages, manual hospital beds, basic surgical instruments (such as scissors, tweezers)

Regulatory requirement: Only need to file with the municipal drug regulatory department, no registration approval required

Class II (moderate risk)

Judgment criteria: Strict control and management are required, usually involving invasive procedures, contact with mucous membranes, or short-term implantation

Typical products: electronic sphygmomanometer, blood glucose meter, condom, acupuncture and moxibustion needle, ultrasonic diagnostic instrument

Regulatory requirements: It is necessary to apply for registration with the provincial drug regulatory department and submit clinical evaluation materials

1. Class III (High Risk)

   Judgment criteria: Directly related to life support, long-term implantation, or contact with the circulatory/central nervous system

   Typical products: pacemakers, artificial joints, vascular stents, CT machines, absorbable sutures

   Regulatory requirements: Approval from the National Medical Products Administration is required, and a comprehensive clinical data and risk management report must be submitted

    

    

   Example of dynamic adjustment:< br class="container-utlnW2 wrapper-d0Cc1k undefined" style="-webkit-font-smoothing: antialiased; box-sizing: border-box; -webkit-tap-highlight-color: rgba(0, 0, 0, 0); outline: none; border: 0px solid; margin: 1em; padding: 0px; font-size: 20px; content: ""; display: block; overflow-anchor: auto;" />2025  The latest classification definition shows that tendon repair patches, collagen cartilage repair fillers, etc. are classified as Class III due to their involvement in tissue repair and long-term implantation. Some low-risk products such as medical isolation gowns and protective face masks have been adjusted from Class II to Class I, reflecting regulatory flexibility

2、 EU: Four level classification under the MDR framework

According to the Medical Device Regulation (MDR 2017/745), the European Union classifies medical devices into Class I, Class IIa, Class IIb, and Class III, with risks gradually increasing

Class I (Low Risk)

Judgment criteria: non-invasive, non implantable, and not in contact with the circulatory system/central nervous system

Typical products: medical dressings, manual surgical instruments, blood pressure cuffs

Regulatory requirement: Only self declaration (CE certification) is required, without the need for review by a notified body

IIa category (low to moderate risk)

Judgment criteria: Short term invasive procedures or contact with tissues/body fluids

Typical products: urinary catheter, hearing aid, dental filling material

Regulatory requirements: Technical documents must be reviewed by a notified body (such as T Ü V S Ü D) and submitted

IIb category (moderate high risk)

Judgment criteria: Long term invasive procedures, exposure to the circulatory system, or diagnostic/therapeutic functions

Typical products: dialysis equipment, defibrillators, gastroscopes

Regulatory requirement: It is necessary to announce the institution's review of clinical data and risk management plans

1. Class III (High Risk)

   Judgment criteria: Implanted into the human body for more than 30 days, supporting vital functions, or directly affecting the central nervous system

   Typical products: artificial heart, heart valves, absorbable implants

   Regulatory requirement: Strict review by the notified body is required, and a complete clinical research report must be submitted

    

    

   Latest adjustments in 2025:< br class="container-utlnW2 wrapper-d0Cc1k undefined" style="-webkit-font-smoothing: antialiased; box-sizing: border-box; -webkit-tap-highlight-color: rgba(0, 0, 0, 0); outline: none; border: 0px solid; margin: 1em; padding: 0px; font-size: 20px; content: ""; display: block; overflow-anchor: auto;" /> According to the EU MDCG guidelines, the classification of COVID-19 detection products is adjusted to: SARS-CoV-2 nucleic acid detection is classified as Category B (former Category D), and the self-test device is classified as Category C (former Category D), reflecting the reassessment of infectious disease detection risks

3、 India: A-D risk classification system

India adopts a four level classification system of A (low-risk), B (low moderate risk), C (moderate high risk), and D (high risk):

Class A

Judgment criteria: non-invasive and not in contact with the human body or only in contact with intact skin

Typical products: surgical masks, alcohol cotton balls, disposable gloves

Regulatory requirement: No registration required, only self declaration required

Class B

Judgment criteria: non-invasive but in contact with mucous membranes or for short-term use

Typical products: thermometers, blood pressure monitoring devices, dental impression materials

Regulatory requirement: Registration with the Central Drug Standards Control Organization (CDSCO) is required

Class C

Judgment criteria: invasive operation or contact with body cavity/fluid

Typical products: implants, hemodialysis catheters, cardiac stents

Regulatory requirement: CDSCO approval is required and clinical data must be submitted

1. Class D

   Judgment criteria: Long term implantation, life support, or contact with the circulatory system/central nervous system

   Typical products: pacemakers, artificial joints, intravascular stents

   Regulatory requirements: Strict review by CDSCO is required, usually requiring clinical trials to be conducted

   4、 Comparison of Classification in Other Countries/Regions

   US FDA

   Classification logic: Class I (general control), Class II (special control), Class III (pre-market approval)

   Typical products: Class I (tongue depressor), Class II (electrocardiograph), Class III (cochlear implant)

   Regulatory differences: Class II requires 510 (k) pre certification, while Class III requires PMA pre-market approval

   Japan

   Classification logic: Class I (non management), Class II (self inspection), Class III (third-party audit), Class IV (approved by the Ministry of Health, Labour and Welfare)

   Typical products: Class IV (pacemakers), Class III (CT machines)

   5、 Classification confusion points and application suggestions

   Differences in terminology

   China's Class I ≠ EU's Class I: The risk of China's Class I is lower than that of EU Class I (such as China's Class I including some EU Class IIa products)

   Class A/B ≠ Class I/II: Class A in India corresponds to Class I in China, while Class B corresponds to Class II in China, but there are still differences in the specific product classification

   Actual application scenarios

   Regulatory compliance: Exporting to China must comply with NMPA's I-III standards, while exporting to the EU must match MDR's I-III and IIa/IIb subdivisions

   Product development: High risk devices (such as implants) require advance planning of clinical pathways, while low-risk devices can simplify the registration process

   Market access: Class A products in India can be quickly launched, while Class D products require a 12-18 month approval cycle

   Dynamic tracking mechanism

   China updates the Classification Catalogue of Medical Devices every year, and the EU MDR continues to adjust the classification rules (such as the COVID-19 test downgrade in 2025). Enterprises need to regularly consult the official announcement.

   Suggest using tools such as NMPA Medical Device Classification Definition Platform and EU EUDAMED Database to query product classifications in real-time

   Medical EMC Solution