For the implementation of the regulations on the supervision and administration of medical devices (hereinafter referred to as the regulations) medical device classification management, the requirements of the relevant related work made solid progress review of medical equipment examination and approval system reform, further consolidate the basis for classified management of medical device industry, the state food and drug supervision and administration bureau (hereinafter referred to as the bureau) according to the overall deployment of medical device classification management reform launched in July 2015, the catalog of medical device classification revision work.
1. Revision background
In 2002, the state food and drug administration issued the implementation of the catalog of medical device classification (the drug safety machinery [2002] no. 302, hereinafter referred to as the 2002 version of the directory), the medical device regulatory and industry development has played a positive role in promoting. Medical devices industry after more than 10 years, the rapid development of products to the rapid growth of the technology of complex products constantly emerging, the 2002 version classification directory already can not adapt to the demands of the development of the situation, mainly embodied in the following aspects: one is the 2002 version of the directory only provides product category and commodity information, for example, the lack of the product description and intended use to define the key to product information, can easily lead to inconsistent classification management in understanding, affect the unity and fairness of the examination and approval; Secondly, under the new situation of technological development, the overall design and hierarchy of the 2002 edition show some irrationality, and the product classification is intersected. Three is 2002 version of the directory can not completely cover new products in recent years, although many times in the form of the classification definition files about the management of the product category, some make up for the shortage of the 2002 version of the directory, but due to a lack of integrity and systemic, still cannot meet the need. To solve the above problems, the original state drug administration since 2009 organizations to carry out the 2002 version of the directory changes to the work, published on August 28, 2012 revision completed 6823 medical ultrasonic instruments and related equipment and other four subdirectory, and carry out the research work of other subdirectories revision.
Released in 2014 on the implementation of the regulations for medical device classification work put forward higher request, in order to solve the 2002 version of the directory in question with industry and regulatory requirements, release of comprehensive induction analysis the past medical device classification definition file, combing product information, effective medical device registration and management for the similar foreign medical equipment products are studied, on the basis of in order to further implement the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) required to push forward the reform of medical device classification management, administration according to the reform of medical device classification management work deployment, decided in July 2015 launch the catalog of medical device classification, optimization and adjustment of medical equipment category framework, structure and content.
Ii. Revision process
According to the classifications in the medical equipment management reform work plan deployment, administration established, promote the reform of medical device classification management joint working group as a whole the catalog of medical device classification work in relation to the revision. Administration issued the medical devices category revised work plan, according to the division of duties, the administration device registration department shall be responsible for the overall planning and coordination and administration of medical devices standards management center (hereinafter referred to as the tube center) led, jointly with the administration of medical devices technical evaluation center ShengJu related organization, the national 24 medical equipment standardization technical committee (points) and responsible for the catalog of medical device classification revised 11 medical equipment inspection units, to be responsible for revision of technical work.
Draw lessons from the international medical device classification management ideas, research and analysis of the European Union, the United States, Japan and other countries and regions classified management model, classification management files, in the 2002 version of the directory, 2012 2012 4 subdirectory, class I medical devices such as product catalog and other classification definition file and comb has approved registered medical device product registration information, on the basis of the summary, and repeatedly Yi Gao, in August 2016 to form the classification of medical devices "directory (draft)".
In September 2016, the general administration made public consultation on the classified catalogue of medical devices (draft). And sent a letter to the ministry of industry and information technology, the ministry of civil affairs, health and family planning commission and other relevant ministries and commissions, the biomedical engineering society of China, the Chinese society of biological materials, the China association for medical devices industry association and other academic groups and organizations for advice; In the same period, the general administration organized a face-to-face consultation meeting on supervision, review, inspection, health, scientific research, engineering experts and representative enterprises. At the same time, the general administration has launched the WTO/TBT notification of the classified catalogue of medical devices (soliciting submissions). According to the feedback of the parties, after careful study of the discussion, further revision of the catalogue has been improved to form a catalogue of medical devices (submitted for review). Under the review of the special session of the technical committee of the medical device classification technology committee of the general administration, a further revision was made to form the classified catalogue of medical devices (the new classified catalogue).
Iii. Major revision contents
New the catalog of classification in accordance with the medical device classification rules (the state food and drug supervision and administration of administration makes no. 15) (hereinafter referred to as "classification rules"), the directory does not include the 6840 subdirectories in vitro diagnostic reagents classification (2013 edition) "content and composite products. Major revisions are as follows:
(1) the general situation
The new catalogue will be a list of 43 subdirectories of the 2002 directory. Expanded the 260 product categories into 206 first-class product categories and 1,157 secondary product categories; Increased product expectations and product descriptions; On the basis of the original 1008 product names, the example of 6609 typical product names is expanded.
(2) subdirectory Settings
Because the 2002 edition catalogue from multiple angles, the number of subdirectories is more, it is easy to cross between directories due to the lack of unified classification principle. The new classification catalogue of main technology as the main line, more from the perspective of the function of medical instruments and clinical use products, divided into committee examined and approved by the general administration of classification, the number of subdirectories by 43 reduced to 22. Compared with the 2002 edition, the directory revision framework is more reasonable and hierarchical.
The list of 22 subdirectories in the revised catalogue is as follows:
1. Surgical instruments set up 4 sub-directories: general surgical instruments, "01 active instruments" and "02 passive surgical instruments"; Because of the special requirements of the contact nerve and blood vessels in the classification rules, the "03 nerve and vascular surgical instruments" were set up separately. Orthopaedic surgical instruments are large and wide, and the products are multifarious and set up "04 orthopaedic instruments".
2. Active appliance equipment set up 8 subdirectory, respectively is: "05 radiotherapy equipment" "06 medical imaging instrument" "07 medical diagnosis and monitoring instrument" "08 breathing, anesthesia and emergency equipment" "09 physical therapy instrument" "10 blood transfusion, dialysis and extracorporeal circulation equipment," the 11 medical instrument disinfection sterilization equipment, 12 active implanted devices.
3. The equipment with no source equipment is set up 3 sub-directories, namely, "13 passive implanted devices", "14 injection and loss, nursing and protective equipment", "15 patient bearing instruments".
4. According to the clinical departments, 3 subdirectories are divided into: 16 ophthalmological instruments, 17 oral instruments, 18 obstetrics and gynecology, reproductive and contraceptive devices.
5. 19 medical rehabilitation equipment and 20 Chinese medicine instruments is according to the regulations on the supervision and administration of medical devices in medical rehabilitation instrument and equipment of traditional Chinese medicine special provisions on the administration of the two categories of products and single set of subdirectories.
6. "21 medical software" is the subdirectory of medical independent software products.
7. The subdirectory of the 22 clinical inspection instrument was placed at the end to reserve space for follow-up in vitro diagnostic reagents.
(3) contents of the catalogue
1. The new classification catalogue is compared with the 2002 edition catalogue, which is more abundant and perfect in content, with more comprehensive product coverage and a clear improvement in the scientific nature and guidance of the catalog.
The contents of the reference 2012 released four subdirectory, new revisions of the classified catalogue of Settings: subdirectories, category number, primary product categories, secondary product category, product description, intended use, goods name, for example, management category 8 items, as shown in table 1. The contents of the 2002 edition are 5 contents: subdirectory, category number, product category, name of category, management category, as shown in table 2.
Table 1. New classification directory structure
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子目录
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类别序号
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一级产品类别
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二级产品类别
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产品描述
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预期用途
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品名举例
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管理类别
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表2 2002版目录结构
2. The added "product description" and "expected purpose" of the catalogue are the basic description of the generic contents of a class of products, which are used to guide the comprehensive determination of the category of specific products; The names of the names listed are the normative and representative names of the common names of medical devices.
3. The directory changes to the process, according to the medical equipment production, management, usage of collection, change of medical equipment risk assessment, the administration of medical device classification technical committee for professional audit, reduce the long time to market, product maturity high part of the management of the medical devices category, for always not a unified specification for examination and approval of product management category.
Iv. Other issues
(1) priority principle of product classification of medical devices
In view of the complexity of medical device products, products with overlapping or interdisciplinary techniques shall be determined in the following order of priority: first, according to the priority of clinical specialties; Secondly, the multi-functional products are in order according to the main functions, high-risk functions and new functions. Third, according to the accessories of medical device management, priority belongs to the sub-directory or product category of the whole machine.
(2) labeling of the pharmaceutical products
On November 12, 2009, the state food and drug administration issued "about YaoXie combination parties on matters relating to the product registration notice" (no. 16, 2009, hereinafter referred to as the 16 announcement) regulation: the mainly role of medical equipment YaoXie combination products, to declare the medical device registration, the applicant according to the product property examination and approval opinions, declare to the state food and drug administration for drugs or medical device registration, and indicate the "YaoXie combination products" in the application form. In line with the announcement of the 16, in the new catalogue, according to the medical device management of the drug combination product, in addition to listed the management category, labeled "drug combination products".
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