Promote the management of medical equipment classification management is the "three five" during the main task. Medical equipment classification management reform is also an important part of the reform of medical device examination and approval system.
"Thirteen Five" period, to promote the medical device classification management reform of the overall idea is: to improve the medical device classification technical committee and professional group, the establishment of medical equipment product risk assessment mechanism and classification of dynamic update mechanism.
Classification and management of medical devices in China
Classification is the basis of medical device supervision, the relationship between the development, production, circulation and use of the establishment of specific links. China's medical equipment to implement three classification management, according to the degree of risk from low to high, divided into the first category, the second and third category. The principle of classification is based on the degree of risk to determine.
Medical equipment has a multi-disciplinary coverage, knowledge-intensive features, involving machinery, electronics, materials, life sciences and many other disciplines, both a strong professional, but also a comprehensive cross-professional, many products, different Span, from the most simple gauze, cotton swabs, to the implantation of human support for life-sustaining pacemakers, vascular stents, etc., are medical devices.
These characteristics of medical equipment, the decision of its management should be in accordance with the risk level of its safety effectiveness of the classification management, in line with the objective rules of medical equipment and development requirements. Classification management according to the degree of risk is also an internationally accepted rule.
China's classification rules under the guidance of the classification system, that is, classification rules and classification of coexistence, classification directory priority. "Medical Device Classification Rules" and "Medical Device Category" as "Medical Device Supervision and Management Regulations" supporting the classification management of regulatory and regulatory documents, by the State Council food and drug supervision and management departments to develop. At present, the "Medical Device Classification Rules" has been released, the new version of "medical device classification directory (draft)" is seeking comments.
The food and drug supervision and administration department of the State Council shall classify according to the degree of risk of medical devices and analyze and evaluate the changes in risk according to the production, operation and use of medical devices, and adjust the catalogs in a timely manner. Analysis and evaluation of the changes in the risk of medical equipment should be brainstorming, fully listen to medical equipment manufacturing enterprises and the use of units, industry organizations, and refer to the international medical device classification practice, the degree of risk of medical equipment to make an objective decision.
In accordance with the principle of fairness and impartiality, the documents related to the classification and management of medical devices should be published in the society, including the classification of medical devices, the classification of medical devices and the classification of new medical devices, the adjustment of medical equipment management category.
Medical device management category to determine the main basis
Factors that should be taken into account in assessing the degree of risk in the medical device, including the intended purpose, structural characteristics, and methods of use of the medical device.
Specifically, according to the intended purpose and structural characteristics of different medical devices can be divided into active medical devices, passive medical equipment and in vitro diagnostic reagents three categories.
Each category has a number of different forms of use, such as passive medical devices, including liquid storage and preservation equipment, changes in blood fluid equipment, medical dressings, surgical invasive instruments, re-use of surgical instruments, disposable sterile equipment, implantation Equipment, contraceptive and family planning equipment, etc .; active medical devices include energy therapy equipment, diagnostic monitoring equipment, ionizing radiation devices, active implantation equipment, laboratory equipment, etc .; in vitro diagnostic reagents include kits, calibrators, Quality control products, reagents, microbial culture media, sample processing products.
To determine the classification of medical devices, the need to consider whether the medical device exposure to the human body, contact parts, the possibility of injury to the human body, the impact on medical effects, the use of time and other factors used in the state.
The Medical Device Classification Rules are used to guide the development of medical device catalogs and the management of new medical devices, as of January 1, 2016.
Because of the complexity of medical equipment, the degree of risk of medical equipment must be evaluated according to the expected purpose, structural characteristics, use form and usage status of medical equipment. On this basis, it is possible to determine the appropriate management category.
Therefore, the definition of medical device classification is a very strong technical work.
Reform Classification Defines the work pattern
To improve the medical device classification management mechanism to protect the scientific classification of medical equipment, impartiality and authority, November 26, 2015, the State Food and Drug Administration set up a medical device classification technical committee, as medical equipment classification and related work The technical support.
The committee is composed of the Executive Committee and a number of professional groups, the Secretariat is located in the General Administration of Medical Device Standard Management Center. Will be organized by the center directly to the experts to carry out the classification of the work of the definition of the operation mode, and gradually transition to the classification by the Technical Committee and its professional group classification.
The Executive Committee of the First Medical Device Classification Committee consists of 36 members who will organize active surgical instruments, passive surgical instruments, radiotherapy and medical imaging equipment, medical care, monitoring and monitoring in accordance with the classification scheme of the Technical Committee of the Classification Technical Committee. First aid, physical therapy equipment, active implantation equipment, passive implantation equipment, dialysis, cardiopulmonary bypass, injection, care and protective equipment, ophthalmic instruments, dental equipment, obstetrics and gynecology, reproductive and contraceptive devices, medical rehabilitation Equipment, medical equipment, medical software, clinical testing a total of 16 professional members of the collection of work, and actively absorb clinical medicine, engineering and technical research and other aspects of outstanding experts and engaged in medical equipment registration, supervision, review, inspection professionals Form a professional group.
The establishment of a professional group will promote the transformation of medical device product classification to define the working mode, and give full play to its professional role in the definition of medical device classification。
Create a directory dynamic update mechanism
The current 2002 edition of the Catalog of Medical Devices (hereinafter referred to as "Catalog") has been in use for more than 10 years. During this period, the rapid development of medical equipment industry, the rapid growth of product categories, the emergence of complex technology products, 2002 version of "directory" has been unable to adapt to the situation requirements, mainly reflected in three aspects:
First, the 2002 version of the "directory" only to provide product categories and product names for example, the lack of product description and intended use of key products such as the definition of information, easy to lead to classification management work to understand inconsistencies, affecting the registration approval of the unity and normative;
Second, the new situation of technological development, the 2002 version of the "directory" of the overall design and level set to show a certain irrational, product classification exists cross;
Third, the 2002 version of the "catalog" can not completely cover the emergence of new products in recent years, although many times in the form of classification of documents clearly defined the product management category, part of the lack of, but the lack of integrity and systematic, still can not meet the requirements , The lack of "directory" system of dynamic maintenance mechanism.
In order to better serve the industry and regulatory needs, "thirteen five" period to complete the following two tasks:
First, the revision of "medical device classification directory". Reform the existing medical device classification directory framework, rational design of the overall structure of the directory and hierarchical structure, to solve the product classification of the cross and contradictions, and consider the Chinese medicine diagnosis and treatment equipment and rehabilitation aids medical devices classified as separate subdirectories.
According to the general plan of the work plan of medical equipment classification reform, through the previous documents combing, as well as the United States, Japan, Europe and other developed countries and regions, medical equipment classification model to study, sort out more than 60,000 medical device registered products, and further optimize Frame structure, the original directory of 43 subdirectories into 22, the original 265 product categories into 205 categories and 1094 sub-categories, the formation of the "medical device classification directory (for comments)", now Completion of public solicitation will be officially issued after further argument.
Second, the establishment of dynamic adjustment mechanism. Reasonable adjustment of part of the product management category, according to the expected purpose of medical devices, structural features, the use of methods and other factors, refer to the international medical device classification practice, will be part of the mature, safe and control of medical equipment, appropriate to reduce classification. According to the medical equipment production, operation, use, combined with daily supervision and inspection, adverse event monitoring and re-evaluation, quality accidents, etc., timely analysis of the risk of medical equipment evaluation.
The State Food and Drug Administration is organizing the study of some mature, safe and controllable medical devices, and analyzes and evaluates the risk changes of high-risk medical devices currently administered according to the third category of medical devices. Risk medical device classification principles, and proposed adjustment of some high-risk medical equipment classification varieties. At present, the adjustment of some categories has been reflected in the newly revised catalog, which provides a practical basis for rationally dividing the management category and establishing the dynamic adjustment mechanism.
Synchronize the device to name the work
Medical device naming is an important basic work of medical equipment supervision, but also the world's common exploration of the field of research, complex and challenging.
Uniform norms of the naming system, contribute to the specific classification of specific products. There is no standardized name, medical equipment, foreign body with the same name, the same phenomenon is difficult to avoid the impact of the product accurate and effective identification, and thus affect the classification management of scientific and rigorous.
Based on the characteristics of medical equipment, with reference to drugs, cosmetics, health food on the naming of the provisions of the future of China to establish medical equipment naming rules, generic name terminology guide, generic name directory combination of medical device naming system to naming rules as the basic principle The terminology guidelines are technical standards and eventually develop common name directories and databases.
Naming rules and common names are linked by terms and through. The term "the dictionary", which is the core attribute and characteristic attribute of the product, conforms to the naming convention and specifies the core word and the characteristic word of the specific product to generate the generic name of the corresponding product.
The next step, the General Office will focus on the development of laws and regulations, terminology guidelines and the establishment of common name directory, naming database construction and other aspects of work, in accordance with the plan to establish China's medical device generic name system and fully implemented.