"Classification Rules of Medical Devices" (hereinafter referred to as the "Rules") was reviewed and approved by the State Food and Drug Administration of the State Food and Drug Administration on June 3, 2015，July 14, 2015 State Food and Drug Administration Order No. 15 announced，Starting from January 1, 2016。 

I. Revised the background and main process

Classification Directors under the guidance of classified rules in my country for medical device classification，Classification rules and classification directory coexist，Preferred by classification directory。The "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"), which was revised by the State Council Order No. 650 in 2014 (hereinafter referred to as the "Regulations"), stipulated that "the food and drug supervision and management department of the State Council is responsible for formulating the classification rules and classification directory of medical devices "。

April 2000，Former Drug Administration of Drug Administration has issued Decree No. 15 "Classification Rules for Medical Device" (hereinafter referred to as the original "Classification Rules")，For more than ten years of implementation，It played a positive role in the formulation of the "Catalog of Medical Device" and determining the new product registration category。but，The industry also reflects the original "Classification Rules" and should further meet the needs of the classification work practice of medical device。In order to cooperate with the implementation of the new revision of the "Regulations"，Experience accumulated by the classification of medical equipment，It needs to be detailed and perfect for the original terms and classification judgment forms of the original "Classification Rules"。

2013，The General Administration of Food and Drug Administration started drafting the draft draft of the "Classification Rules of Medical Device"，​​From December 24, 2013 to January 10, 2014, he publicly solicited opinions from the society through the website of the General Administration。During the review stage，"Medical Device Classification Rules" revised draft solicitation draft, from December 4, 2014 to January 4, 2015, passed the Chinese government legal information network to publicly solicit opinions，Reprinted on the website of the General Administration for soliciting opinions。Surgate results for opinions，The General Administration held a special seminar to conduct a serious study，Fully absorb reasonable opinions。June 3, 2015，The General Administration of Administration has reviewed and passed the revised draft for review，July 14th issued by the General Administration of Decree No. 15。

2. Main content 

Original "Classification stake online sports bettingRules" includes 10 and 1 attachment "Classification Judgment Form"，This "Rules" also includes 10 and 1 attachment，The body structure is consistent，It mainly involves the adjustment of language expression and the refinement of technical content。The main modified content includes:

(1) The full text of the original "Classification Rules" quoted the definition of medical equipment in the original "Regulations"。According to the opinions in the revised discussion，The definition of medical device definition of the new "Regulations" has clearly stipulated，Regulations do not have to be repeated，So，This "Rules" does not retain the definition of medical equipment。

(2) Change the "registration category" of the medical device in the original "Classification Rules" to "Management Category"，The category of clear management is not only a registered service，Supervision and other aspects、Supervision and other aspects。

(3) According to Article 4 of the New Regulations，Article 4 of this "Rules" clearly expresses the degree of risk -based risk -based，and the determination of the degree of risk is based on the "structural features、Use form、Use Status "three aspects，Modified to "degree of risk of medical device，It should be based on the expected purpose of medical device，Through structural features、Use form、Use status、Whether to contact the human body and other factors to comprehensively determine。”

(4) The basis of the classification judgment of Article 5 of the "Classification Rules" of the original "Classification Rules"。This "Rules" Article 5 of the Category has been modified in the classification situation、Supplement and improvement:
　　1. According to medical equipment technology and industrial development status，Added "implantation equipment" to the active device category、"Independent Software" two types of medical equipment use forms。
　　2. Delete "Disposal Sterilization Instrument"，To avoid the cross between the use of sterile devices and other passive contact with human devices。At the same time，This "Rules" passed the principle of special classification in Article 6 (8)，Classification of medical devices provided in a sterile form。
　　3. Change the "Drug Delivery Storage Equipment" to "Line Transmission Device"。On the one hand, it is no longer emphasized that only the medicinal solution is transported，Dalog conveys in other forms of liquid are also included in this form of use，Make it covered with a larger coverage; on the other hand，No longer emphasizes the "preservation" function，Different from drug packaging materials。
　　4. Change the "disinfection and cleaning equipment" under the passive medical equipment to "medical device cleaning and disinfection equipment"，"Medical disinfection sterilization equipment" under the active medical equipment item to "medical device disinfection sterilization equipment"，It is clear that the equipment and equipment that is only used only for "medical equipment" disinfection and sterilization is managed according to medical equipment;，Adjust the "medical device cleaning and disinfection equipment" from the "contact human device" item of the classification judgment form to，In the form of product use。
　　5. Change "Laboratory Instrument and Equipment" to "Clinical Test Instrument Equipment"，To avoid the confusion of the management attributes of non -medical laboratory equipment。
　　6. Change "other passive contact and auxiliary medical equipment" to "other passive Stake Sports Bettingmedical equipment"，Change "Other stake sports betting appactive medical devices or active auxiliary equipment" to "other active medical equipment"，Make it more accurate。
　　7. Change the "cavity" to "cavity (mouth)"，Make it cover the cavity of the cavity and permanent artificial opening with the same degree of risk，Provides a classification basis for products such as preparation equipment。

(5) Modify the specific content of the principle of determination of the original "Classification Rules"、Supplement and perfect，Adjust the relationship and order of the between it。

This "Rules" first shows，Classification of medical devices Applicable Classification Judgment Form，There is a special situation specified in this article，The corresponding special stake betting appClassification principles are applicable at the same time。

Twelve special stake betting appClassification principles listed in Article 6 of this "Rules"，According to "General Requirements" in turn、"Manage according to the third category"、"Management according to the third or second category" and "Management according to the second category"，Classified and sorted。Modification content includes:
　　1. The original "Category Rules" "If the purpose and role of the same product are different，Classification should be judged separately "、"Medical equipment acting on several parts of the human body，According to the form of high risk、Classification of use status "and" If a medical device can apply two categories，The three stake betting appClassification principles should be taken "the highest classification"，Summarized as "If the same medical device is applicable to two or more classifications，The highest degree of risk of risk should be taken "。
　　2. The stake betting appClassification principles of equipment bag products were added，Determine "Medical Device Pack composed of multiple medical devices，Its classification should be consistent with the most risk -in -laws in the bag "，To meet the needs of the classification management of equipment bags。
　　3. Modified the content of the original "Annexes alone" in the "Classification Rules"，Emphasize when classified the medical device that can be used as an attachment，The effect of attachment on the safety effectiveness of the supporting subject medical equipment must be considered，instead of only considering the attachment situation separately。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。
　　4. Delete the original "Classification Rules" "Medical Device in combination with other medical devices，Explanation of classification separately "respectively，To eliminate ambiguity，Determine that each medical device is separated by separate categories。
　　5. Delete the "Software to control the function of the medical device" in the original "Classification Rules".，Software that meets the definition of medical equipment is divided into "embedded software" and "independent software"，and "Embedded Software" and the hardware used by its supporting facilities are registered and managed according to a medical equipment product，No separate classification; therefore，This "Rules" refer to the International Medical Device Supervision Institution Forum (IMDRF) Guide，Added the definition of "independent software"，and add independent software columns to the attachment classification judgment table。
　　6. According to the current classification status quo，It also added a combination of medicine and robe、Medical dressing、stake betting appClassification principles followed by stake online sports bettingproducts such as orthodontics。

(6) The requirements of dynamic adjustment and classification determined in accordance with the new "Regulations"，The content of the risk of the original "Classification Rules" changes and the management category adjustment of the original "Classification Rules"，List a separate，That is, this "Rules" stipulates in 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 "。

(7) Article 7 of the Original "Classification Rules" is the provisions of the classification work department and classification procedure，According to the opinions in the revised discussion，This "Rules" no longer repeat the contents of the classification rules of the General Administration that have been clearly specified in the new "Regulations" and the classification application procedures for medical devices that have not yet been included in the classification directory; at the same time，According to the needs of reform and development，Article 9 of this "Rules" stipulates that "the State Food and Drug Administration can organize medical device classification expert committees to formulate、Adjust the category of medical device classification "。

(8) In view of since 2007,，Except for blood source screening and in vitro diagnostic reagents containing radioactive nuclein have been included in medical device management，2014 The General Administration of General Administration No. 5 "Administrative Measures for the Registration of Endogenic Diagnostic Reagents" and other documents The classification of in vitro diagnostic reagents has been specified，So，This "Rules" added Article 7 "Classification of in vitro diagnostic reagents in accordance with relevant regulations"。

(9) The term in Article 8 of the Original "Classification Rules"、Amendment and order of interpretation。
This "Rules" adjusts the definition of the term to Article 3，Delete "Risk"、"Surface contact equipment" and "central circulation system" and other words in the classification judgment form。Refer to the EU、International Medical Device Regulatory Institution Forum (IMDRF) Guide and other relevant classification situation，Fine "invasion equipment"、Content of "Planting Equipment"，Added "Skin"、"Dian Road (mouth)"、"Trauma"、"Organization"、"Blood Circulation System"、"Central nervous system"、"Medical Device with Measurement Testing Function"、"Chronic Welfare" and other terms such as instructions。

After modification，"Invasion equipment" refers to，"With all or part of the surgery invaded the human body through the body surface，Contact body tissue、Blood circulation system、Medical equipment 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。"So，Invasive devices should meet two conditions，1 is to use the "surgery" method，The second is invading the body，Contact body tissue，It mainly includes the instrument used in the intervention surgery、Disposal use of sterile surgical equipment and instruments that are temporarily or short -term or short -term。According to the definition of invading the instrument，Pingling needle、Bloody pins、Devices that do not rely on "surgical" means、or instruments that do not invade the human body such as medical stake sports betting appStake Sports Bettingdressing，None of the "invasion equipment"，These instruments have corresponding classification channels in this "Rules" to determine and classification。

Because the "Repeated use of surgical equipment" in this "Rules" is also literally in line with the characteristics of the invasion of the instrument，But in order to facilitate the accurate classification judgment，It is necessary to specifically use reuse using surgical equipment as a separate use form for classification，So，This "Rules" also clearly excluded the reuse using surgical equipment。

After modification，The "implantation equipment" in this "Rules" refers to，"With all surgery or partially entered the human body or in the cavity (mouth)，Or it is used to replace the surface of the human body epithelium or eye surface，and stay in the human body after 30 days (inclusive) after the surgery,。"So，This definition clearly clearly meets two conditions at the same time，First is the "implantation location" that meets the prescribed regulations，Second is the "implantation time" that meets the prescribed regulations，The implantation time includes both staying in the human body for more than 30 days，Also includes the situation absorbed by the human body。 

From a broad sense，The category of implanted instruments and invasive equipment also has a certain rearmaking，But each has special requirements in classification，Planting instruments emphasized that staying in the human body after the surgery after the surgery, 30 days (inclusive) or being absorbed by the human body，Entry equipment is mainly temporary or short -term，No long -term use or absorption situation。So，This "Rules" lists the invasion of the instrument and the implantation equipment as two independent forms under the passive contact human device item，In the classification judgment form at the same time，The goal of the long-term use of the equipment into the equipment is "-"、Temporary use and short-term use section target of implantation equipment "-" ("-" means that there is no case)，To distinguish the invasion of the instrument from the instrument from the classification judgment。 

(10) In addition，Modify the content according to the text，The classification of the medical device classification of this "Rules" also adjusted accordingly。

This "Rules" will be implemented from January 1, 2016，Original "Classification Rules" (April 5, 2000, Original National Drug Administration Order No. 15) at the same time abolished。  

(Information Source: Website of the State Food and Drug Administration)