2. Increased the classification principles of the device package products, clear "by more than one medical device package, its classification should be consistent with the package of medical devices with the highest degree of risk," in order to meet the needs of the classification of the device package products management.
3. Modified the original "Classification Rules" in the "separate classification of accessories", emphasizing that the classification of medical devices can be used as an accessory, must take into account the accessory to the main body of the impact of the safety and effectiveness of medical devices, and should not only take into account the accessory of the situation of separate classification. If the accessory has an important impact on the supporting body of medical devices, the classification of the accessory should not be lower than the classification of the supporting body of medical devices.
4. Delete the expression "medical devices used in conjunction with other medical devices should be classified separately" in the original Classification Rules to eliminate ambiguity and make it clear that each medical device is classified separately.
5. Delete the expression "software controlling the function of a medical device is classified in the same category as the medical device" in the original Classification Rules, because software that meets the definition of medical device is divided into "embedded software" and "stand-alone software", and "embedded software" and "stand-alone software". "Stand-alone software", and "embedded software" and its supporting hardware are registered and managed as one medical device product without separate categorization; therefore, the Rules refer to the International Medical Devices Regulators Forum (IMDRF) guidelines and add the following statement Therefore, the Rules refer to the International Medical Device Regulators Forum (IMDRF) guidelines to add the definition of "stand-alone software" and add a stand-alone software item in the Annex Classification Determination Table.
6. According to the current classification status, it also adds the classification principles followed by products such as combination products of medicines and devices, medical dressings and orthopedic devices.
(F) in accordance with the new "Regulations" determined by the dynamic adjustment of the classification requirements, the original "Classification Rules" in Article VI of the degree of risk of medical devices changes and management of the adjustment of the content of the category, a separate article, that is, the Rules in Article VIII, "State Food and Drug Administration in accordance with the production of medical devices, operation, use, timely The State Food and Drug Administration in accordance with the production, operation and use of medical devices, timely analysis and evaluation of changes in the risk of medical devices, and adjustments to the classification of medical devices".
(7) Article 7 of the original Classification Rules provides for the competent authority for classification work and the classification procedure. According to the opinions in the revision discussion, the Rules will not repeat the contents of the new Regulations which have been clearly stipulated that the State Food and Drug Administration shall formulate the rules for the classification of medical devices and the application procedure for the classification of medical devices which have not yet been included in the Classification Catalog. Provides that "the State Food and Drug Administration can organize medical device classification expert committee to develop and adjust the medical device classification directory".
(h) In view of the fact that since 2007, in vitro diagnostic reagents have been included in the management of medical devices, except for those used for blood screening and containing radionuclides, and that the classification of in vitro diagnostic reagents has been stipulated in Decree No. 5 of the General Administration of the State Food and Drug Administration of the People's Republic of China on the Measures for the Administration of Registration of In Vitro Diagnostic Reagents in 2014, the Rule has added the following provision to its Article 7: "In vitro diagnostic reagents shall be classified in accordance with the relevant provisions. In vitro diagnostic reagents are classified in accordance with the relevant provisions".
(ix) The terms, interpretations and their order in Article 8 of the original Classification Rules have been revised.
The Rules adjusted the definitions of terms to Article 3, and deleted the terms "risk", "surface-contact device" and "central circulatory system", which are not used in the Classification Judgment Table. The terms that are not used in the classification and judgment table have been deleted. ", "Cavity (mouth)", "Trauma", "Tissue", "Circulatory System ", "central nervous system", "medical devices with measurement and testing functions", "chronic trauma" and other terms of description.
After the amendment, "invasive device" means, "medical devices that invade the human body with the aid of surgery, in whole or in part, through the body surface, and come into contact with the tissues of the body, the blood circulatory system, the central nervous system and other parts of the body, including devices used in interventional surgery, single-use sterile surgical instruments and devices that remain in the human body temporarily or for a short period of time. devices that remain in the human body temporarily or for a short period of time, etc. Invasive devices in this rule do not include reused surgical instruments." Therefore, invasive devices should meet two conditions, one is by means of "surgery", and the other is to invade the body and contact the body tissues, which mainly includes devices used in interventional procedures, single-use sterile surgical devices and devices temporarily or short-term left in the body. According to the definition of invasive devices, puncture needles, blood collection needles, urinary catheters and other devices that do not rely on "surgical" means, or medical dressings and other devices that do not invade the human body are not "invasive devices", and these devices are classified accordingly in the Rules. Judgmental classification.
Since "reusable surgical instruments" in the Rules literally meets the characteristics of invasive devices, but in order to facilitate accurate classification, it is necessary to classify reusable surgical instruments as a separate form of use, therefore, the Rules also include in the Therefore, this Rule also expressly excludes reusable surgical instruments from the definition of "invasive instrument."
After the amendment, "implanted device" in these Rules means "a medical device that is wholly or partially inserted into the body or a cavity (orifice) with the aid of a surgical procedure, or is used to replace the epithelial surface of the human body or the surface of the eye, and either stays in the body for 30 days or more after the surgical procedure or is absorbed by the human body. medical device that is absorbed by the human body." Therefore, the definition of the implanted device must meet two conditions, one is to comply with the specified "implantation location", and the other is to comply with the specified "implantation time", the implantation time includes both stay in the body for more than 30 days, and also include the body absorbed the situation.
Broadly speaking, the scope of implanted devices and invasive devices also have a certain overlap, but each has a special requirement in the classification, implanted devices emphasize the end of the surgical process to remain in the body for 30 days (including) or absorbed by the human body, while the invasive devices are mainly temporary or short-term use, there is no long-term use or absorption of the situation. Therefore, the Rules list invasive devices and implantable devices as two separate forms of use under the heading of devices for passive contact with the human body, and at the same time, in the categorization table, the columns for the long-term use of invasive devices are marked as "-", and the columns for the temporary use and short-term use of implantable devices are marked as "-" ("-"). " ("-" means not available) to distinguish invasive devices from implantable devices in the classification decision.
(x) In addition, in accordance with the amendments to the main text, the table of classification decisions for medical devices annexed to these Rules has been adjusted accordingly.
The Rules shall come into force on January 1, 2016, the original "Classification Rules" (April 5, 2000, the former State Drug Administration Order No. 15) shall be repealed simultaneously.