Article 1 is to standardize medical device classification，According to the "Regulations on the Supervision and Administration of Medical Device"，Develop this rule。
Article 2 This rule is used to guide the formulation of medical device classification directory and determine the management category of new medical equipment。
Article 3 The meaning of the term in this rule is:
(1) The expected purpose
Refers to the product manual、Tags or promotional information，The role that should be obtained by using medical equipment。
(2) Specified medical equipment
Not relying on electrical energy or other energy，But the energy generated by the human body or gravity，Medical devices that play their functions。
(3) Active medical equipment
Any relying on electrical energy or other energy，instead of energy directly produced by the human body or gravity，Medical devices that play their functions。
(4) Invasion equipment
With all or part of the surgery invaded the human body through the body surface，Contact body tissue、Blood circulation system、Medical Device in the central nervous system and other parts，Including the equipment used in the intervention surgery、Disposal use of sterile surgical equipment and device that stays in the human body for a short time or short -term。The invasion equipment in this rule does not include reuse using surgical equipment。
(5) Repeated use of surgical equipment
Cut it in surgery、Cut、Diamond、Saw、Catch、Scrape、Pie、Pump、pinch and other processes，Different connection of any active medical equipment，stake sports betting appPassive medical equipment that can be reopened through certain treatment。
(6) Planting equipment
With all surgery or partially entered the body or in the cavity (mouth)，Or it is used to replace the surface or eye surface of the human body，and stay in the human body after 30 days (inclusive) after the surgery or the medical device absorbed by the human body。
(7) Contact human devices
Direct or indirect contact with patients or medical equipment that can enter the patient。
(8) Use time limit
1. Continuous use time: Medical equipment at the purpose of expected、Uninterrupted actual action time;
2. Temporary: The continuous use of medical equipment is within 24 hours;
3. Short -term: The continuous use of medical device expectations is more than 24 hours (inclusive)、Within 30 days;
4. Long -term: The continuous use of medical device expectations is above 30 (inclusive)。
(9) Skin
Until damaged skin surface.
(Ten) Condor (Port)
Oral、Nasal cavity、esophageal、outer ear canal、Rectal、vagina、urethral natural cavity and permanent artificial opening。
(11) Creative
Various injury factors affect the organizational structure integrity destruction or dysfunction caused by the human body。
(12) Organization
Human body tissue，Including bone、Dental pulp or dentin，excluding blood circulation system and central nervous system。
(13) The blood circulation system
Vascular (except capillary) and heart.
(14) Central nervous system
brain and spinal cord.
(15) Independent software
Have one or more medical purposes，You can complete your expected purpose without medical equipment hardware，Software running on the general computing platform。
(16) Medical equipment with metering test function
Used to determine physiology、Pathological、Anatomical parameters，or quantitative measurement of medical equipment for the energy or material of the human body，The result of the measurement needs to be accurate，and the accuracy of the result will have a significant impact on the patient's health and safety。
(17) Chronic wounds
Long -term non -healing wounds formed by various reasons，such as intravenous ulcers、arterial ulcer、Diabetic ulcers、Evolved ulcers、Stress ulcer, etc.。
Article 4 The medical device is from low to high at the degree of risk，Management category is divided into the first category、Two and third categories。
The degree of risk of medical equipment，It should be Stake Sports Bettingbased on the expected purpose of medical device，Through structural features、Use form、Use status、Whether to contact the human body and other factors comprehensive judgment。
Factors that affect the degree of risk of medical equipment，Medical equipment can be divided into the following situations:
(1) Different from the structural characteristics，Divided into stake sports betting appPassive medical equipment and active medical equipment。
(2) According to whether to contact the human body，Divided into contact with human devices and non -contact human devices。
(3) According to different structural characteristics and whether to contact the human body，The form of medical equipment includes:
Specified contact human devices: liquid transportation equipment、Change the blood liquid equipment、Medical dressing、Invasion equipment、Repeated use of surgical equipment、implantation equipment、contraception and family planning equipment、Other passive contact human devices。
Careless non -contact human instruments: care equipment、Medical equipment cleaning and disinfection equipment、Other passive non -contact human devices。
Equivalent contact human devices: Energy therapy equipment、Diagnostic monitoring equipment、liquid conveying equipment、ionizing radiation equipment、implantation equipment、Other active contact with human equipment。
Active non -contact human device: clinical testing instrument equipment、Independent software、Medical Device Disinfected Sterilization Equipment、Other active non -contact human devices。
(4) According to different structural features、Whether to contact the human body and use form，The use status of medical equipment or its impact includes the following situations:
Specified contact human instruments: divided into temporary use according to the time limit of use、Short -term use、Long -term use; the part of contact with the human body is divided into skin or cavity (mouth)、Trauma or organization、Blood circulation system or central nervous system。
Patriotic non -contact human instrument: Basically, it does not affect the degree of impact on the effect of medical treatment、Minor impact、Important impact。
Equivalent contact with human instruments: divided into mild damage according to the degree of damage that may be caused according to the out of control、Medium damage、Serious injury。
Original non -contact stake betting apphuman instruments: Basically, it does not affect the degree of impact on the effect of medical treatment、Minor impact、Important impact。
Article 6 The classification of medical devices shall be classified according to the category of medical equipment (see attachments)。There is the following circumstances，It should also be classified in conjunction with the following principles:
(1) If the same medical equipment is applicable to two or more classifications，The highest degree of risk of risk shall be adopted; a medical device package composed of multiple medical devicesMy stake betting app，Its classification should be consistent with the most risk -level medical equipment。
(2) Medical equipment that can be used as an attachment，Its classification shall comprehensively consider the safety of the attachment to the supporting subject medical device、Effective effects; if the attachment has an important impact on the supporting subject medical equipment，The classification of the attachment should not be lower than the classification of the supporting subject medical equipment。
(3) Medical equipment that monitor or affects the main functions of medical equipment，Its classification shall be monitored、Classification of medical devices influence。
(4) Pharmaceutical combination products based on medical equipment，According to the third category of medical device management。
(5) Medical equipment that can be absorbed by the human body，According to the third category of medical device management。
(6) The active contact human device that has an important impact on medical effects，According to the third category of medical device management。
(7) Medical dressing if there is the following circumstances，According to the third category of medical device management，Including: It is expected to have anti -tissue or organ adhesion function，As an artificial skin，Creative surfaces that are damaged in the deeper dermis or the damaged tissue below，Used for chronic wounded surface，or it can be absorbed by the human body。
(8) Medical equipment provided in the form of sterileMy stake betting app，Its classification should not be less than the second category。
(9) Pulling through pull、Open、Reverse、Pressing grip、Bending and other ways of role，Actively apply for the human body、Activation equipment that can dynamically adjust the fixed position of the limb (excluding only fixing、Supporting medical equipment，It does not include medical devices or medical devices that perform temporary orthopedic or after surgery or other treatments in surgery.My stake betting app，Its classification should not be less than the second category。
(10) Medical equipment with metering test functionMy stake betting app，Its classification should not be less than the second category。
(11) If the expected purpose of the medical device is to specify the treatment of a certain diseaseMy stake betting app，Its classification should not be less than the second category。
(12) Used to complete the pinch under the endoscope、Cutting tissue or stones and other surgical operations operating without surgical equipment，Management according to the second category of medical device。
Article 7 of the in vitro diagnostic reagent is classified in accordance with relevant regulations。
Article 8 The State Food and Drug Administration is produced according to medical equipment、Business、Use，Timely analyze the risk changes of medical equipment、Evaluation，Adjust the category of medical equipment。
9 The State Administration of Food and Drug Administration can organize medical device classification Expert Committee to formulate、Adjust the category of medical equipment。
Article 10 This rule will be implemented from January 1, 2016。The "Classification Rules of Medical Devices" published on April 5, 2000 (Order No. 15 of the State Drug Administration) at the same time。
Annex: Classification of Medical Devices
