During the 13th Five-Year Plan period, there will be new developments in the classification management of medical devices!
Release time:
2017-07-13
The promotion of the reform of medical device classification management is a key task during the "13th Five-Year Plan" period. The reform of medical device classification management is also an important part of the reform of the medical device review and approval system. During the "13th Five-Year Plan" period, the overall idea for promoting the reform of medical device classification management is to improve the medical device classification technical committee and specialized groups, and to establish a risk assessment mechanism for medical device products and a dynamic updating mechanism for the classification catalog. In China, the classification management of medical devices is the foundation of medical device regulation, which relates to the establishment of specific systems in the research and development, production, circulation, and use of medical devices. China implements a three-level classification management system for medical devices, categorized according to the level of risk.
Promoting the reform of medical device classification management is a major task during the 13th Five-Year Plan period. The reform of medical device classification management is also an important part of the reform of the medical device review and approval system.
During the 13th Five-Year Plan period, the overall idea for promoting the reform of medical device classification management is to improve the medical device classification technical committee and specialized groups, and establish a risk assessment mechanism and a dynamic update mechanism for the classification catalog of medical device products.
China implements classified management of medical devices.
Classification is the foundation of medical device regulation, relating to the establishment of specific systems in the research, production, circulation, and use of medical devices. China implements a three-level classification management system, categorizing devices into Class I, Class II, and Class III according to their risk levels from low to high. The principle of classification is based on the assessment of risk levels.
Medical devices are characterized by multidisciplinary coverage and knowledge intensity, involving numerous fields such as mechanics, electronics, materials, and life sciences. They possess strong professionalism as well as interdisciplinary comprehensiveness, with a wide variety of products that differ in composition and risk levels, ranging from simple gauze and cotton swabs to life-sustaining implants like pacemakers and vascular stents.
These characteristics of medical devices determine that their management should be classified according to risk levels to ensure safety and effectiveness, in line with the objective laws and development requirements of medical devices. Implementing classification management according to risk levels is also an internationally accepted practice.
China implements a classification catalog system guided by classification rules, meaning that classification rules and classification catalogs coexist, with priority given to the classification catalog. The "Medical Device Classification Rules" and the "Medical Device Classification Catalog" are regulations and normative documents related to classification management, formulated by the State Council's food and drug regulatory department. Currently, the "Medical Device Classification Rules" have been published, and the new version of the "Medical Device Classification Catalog (Draft for Comments)" is under consultation.
The State Council's food and drug regulatory department classifies medical devices based on their risk levels and analyzes and evaluates changes in risk based on the production, operation, and usage of medical devices, making timely adjustments to the classification catalog. The analysis and evaluation of changes in medical device risk should be a collective effort, fully considering the opinions of medical device manufacturers, users, industry organizations, and referencing international medical device classification practices to make objective determinations of risk levels.
In accordance with the principles of fairness, justice, and openness, documents related to medical device classification management should be made public, including the "Medical Device Classification Rules," the "Medical Device Classification Catalog," and the classification results of new medical devices, as well as adjustments to medical device management categories.
The main basis for determining the management category of medical devices.
Factors to consider when evaluating the risk level of medical devices include the intended purpose, structural characteristics, and usage methods of the medical devices.
Specifically, based on differences in intended purpose and structural characteristics, medical devices can be divided into three major categories: active medical devices, non-active medical devices, and in vitro diagnostic reagents.
Each category further includes several forms of use, such as non-active medical devices mainly including liquid delivery and storage devices, blood and fluid altering devices, medical dressings, surgical invasive devices, reusable surgical instruments, single-use sterile devices, implantable devices, contraceptive and family planning devices, etc.; active medical devices mainly including energy therapy devices, diagnostic monitoring devices, ionizing radiation devices, active implantable devices, laboratory instruments and equipment, etc.; in vitro diagnostic reagents include reagent kits, calibrators, quality control products, reagents, microbiological culture media, sample processing products, etc.
When determining the classification of medical devices, factors related to the contact with the human body, contact sites, the possibility of causing harm to the human body, the impact on medical outcomes, and usage duration should also be considered.
The "Medical Device Classification Rules" are used to guide the formulation of the medical device classification catalog and to determine the management categories of new medical devices, effective from January 1, 2016.
Due to the complexity of medical devices, evaluating their risk levels must involve a comprehensive assessment based on factors such as the intended purpose, structural characteristics, forms of use, and usage status, on which the appropriate management category can be determined.
Therefore, the classification and definition of medical devices is a highly specialized technical task.
Reforming the classification definition work model.
To improve the work mechanism of medical device classification management and ensure the scientific, fair, and authoritative nature of medical device classification, on November 26, 2015, the National Food and Drug Administration established the Medical Device Classification Technical Committee as a technical support for medical device classification and related work.
The committee consists of an executive committee and several specialized groups, with the secretariat located at the Medical Device Standard Management Center of the administration. The current operational model, where experts are directly organized by this center to carry out classification definition work, will gradually transition to research classification definitions by the classification technical committee and its specialized groups.
The first executive committee of the Medical Device Classification Technical Committee consists of 36 members, who will organize the recruitment of committee members for 16 specialized groups, including active surgical devices, non-active surgical devices, radiation therapy and medical imaging devices, diagnosis, monitoring and emergency care, physical therapy devices, active implantable devices, non-active implantable devices, dialysis and extracorporeal circulation devices, infusion, nursing and protective devices, ophthalmic devices, dental devices, obstetrics, reproductive and contraceptive devices, medical rehabilitation devices, traditional Chinese medicine devices, medical software, and clinical testing, according to the specialized group setup plan of the classification technical committee, actively attracting experts with significant achievements in clinical medicine, engineering technology research, and professionals with years of experience in medical device registration, regulation, review, and inspection.
The establishment of specialized groups will promote the transformation of the work model for medical device product classification definition, fully leveraging their professional role in the classification definition of medical devices.
Establishing a dynamic update mechanism for the catalog.
The current 2002 version of the "Medical Device Classification Catalog" (hereinafter referred to as the "Catalog") has been in use for over 10 years. During this period, the medical device industry has developed rapidly, with a swift increase in product varieties and the emergence of complex technological products. The 2002 version of the "Catalog" can no longer meet the demands of the situation, mainly reflected in three aspects:
First, the 2002 version of the "Catalog" only provides product categories and examples, lacking key information such as product descriptions and intended uses, which can lead to inconsistent understanding in classification management and affect the uniformity and standardization of registration and approval.
Second, under the new circumstances of technological development, the overall design and hierarchical structure of the 2002 version of the "Catalog" show certain irrationalities, with overlaps in product classifications.
Third, the 2002 version of the "Catalog" can no longer fully cover new products that have emerged in recent years. Although several classification definition documents have clarified the management categories of relevant products, partially addressing the shortcomings, the lack of overall and systematic approaches still fails to meet requirements, lacking a dynamic maintenance mechanism for the "Catalog" system.
To better serve the needs of the industry and regulation, the following two tasks must be completed during the 13th Five-Year Plan period:
First, revise the "Medical Device Classification Catalog." Reform the current framework of the medical device classification catalog, reasonably design the overall structure and hierarchical structure of the catalog, address the overlaps and contradictions in product classification, and consider separating traditional Chinese medicine diagnostic and therapeutic devices and rehabilitation auxiliary devices into independent subdirectories.
The General Administration, according to the overall deployment of the medical device classification reform work plan, has organized and analyzed previous documents, as well as studied the medical device classification models of developed countries and regions such as the United States, Japan, and Europe. It has sorted out over 60,000 registered medical device products, further optimized the framework structure, integrated the original 43 subdirectories into 22, and refined the original 265 product categories into 205 major categories and 1,094 minor categories, forming the "Medical Device Classification Catalog (Draft for Comments)." Public consultation has been completed, and it will be officially issued after further verification.
Second, establish a dynamic adjustment mechanism. Reasonably adjust the management categories of some products based on factors such as the intended purpose, structural characteristics, and usage methods of medical devices, referring to international medical device classification practices, and appropriately lower the classification of some mature and safe medical devices. Establish an assessment mechanism for changes in the risk of medical device products, analyzing and evaluating the risks of medical devices in a timely manner based on production, operation, and usage conditions, combined with routine supervision and inspection, adverse event monitoring, re-evaluation, quality incidents, etc.
The National Medical Products Administration is organizing research on appropriately lowering the classification of some mature and safe medical devices, analyzing and evaluating the risk changes of high-risk medical devices currently managed as Class III medical devices, proposing principles for adjusting the classification of high-risk medical devices, and suggesting adjustments for certain high-risk medical device categories. Currently, adjustments for some categories have been reflected in the newly revised classification catalog, providing a practical basis for reasonable classification management and establishing a dynamic adjustment mechanism.
Simultaneously promote the naming of devices.
The naming of medical devices is an important foundational work for medical device regulation and is also a research area that countries around the world are exploring together, which is complex and challenging.
A unified and standardized naming system helps clarify the specific products classified. Without standardized naming, the phenomenon of different objects having the same name or the same object having different names is difficult to avoid, affecting the accurate and effective identification of products, and consequently impacting the scientific and rigorous nature of classification management.
Based on the characteristics of medical devices and referring to the naming regulations for drugs, cosmetics, and health foods, China will establish a medical device naming system that combines naming rules, generic name terminology guidelines, and a generic name catalog in the future, with naming rules as the basic principle and terminology guidelines as technical standards, ultimately formulating a generic name catalog and database.
The connection between naming rules and generic names relies on terminology. The terminology guidelines serve as a "dictionary" of the core attributes and characteristic attributes of products, conforming to naming rules while clearly specifying the core and characteristic terms of specific products to generate the corresponding generic names.
In the next step, the General Administration will mainly focus on the establishment of regulations, terminology guidelines, and the generic name catalog, as well as the construction of the naming database, in accordance with the plan to establish and fully implement the generic name system for medical devices in China.
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