Standardization of naming terminology facilitates the naming standard of medical device generic names

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　　The standardization of naming terms faces challenges

 

　　Standardization is to obtain the best order within the established scope, promote common benefits, establish common use or repeated use clauses for actual or potential problems, and the activities of compiling, publishing and applying documents.
Documents formulated through standardization activities are called standardized documents, which are the general term for documents such as standards, technical specifications, and technical reports.

 

　　The Party Central Committee and the State Council attach great importance to standardization work.
The standardization of medical devices is a basic work in the modernization of my country's medical device governance system and governance capabilities, and has become one of the important tasks in the field of medical device supervision in the new era.

 

　　The standardization of medical device naming terms helps to standardize the general name of medical device products, improve the recognition of similar products, save regulatory resources, promote the high-quality development of the industry, and review the entire life cycle of medical device approval, production, operation, procurement, and use before the market Management is of great significance.
But at the same time, it should also be noted that due to the wide variety and complexity of medical device products, involving multiple disciplines such as electricity, optics, magnetism, materials, medicine, etc.
, the professional field spans a wide range, coupled with the rapid development of new technologies and new materials and multi-functions.
With the integration of products, the standardization of medical device nomenclature is facing challenges.

 

　　Organizational guarantee to consolidate the research foundation

 

　　my country's medical device naming research started relatively late, and the "Regulations on the Supervision and Administration of Medical Devices" issued in 2000 did not clearly stipulate the naming of medical devices.
After the 2004 version of the "Medical Device Registration Management Measures" was issued and implemented in the supporting documents, the medical device product name became one of the approved contents of the registration certificate, but my country has no standardized and unified basis for the medical device product name.
Usually, refer to the "Medical Device Classification Catalog" or Follow industry practices for approval.
Medical devices are managed by classification and classification in my country.
However, due to the unbalanced professional level and ability of the medical device regulatory departments at all levels, the phenomenon of the same name or the same name foreign body of medical devices has become increasingly prominent, which has given all parties concerned about the product.
Identification brings difficulties, affects the market environment and order, but also troubles administrative decision-making and scientific supervision, which is not conducive to the sound development of the industry.

 

　　In order to explore a scientific naming method suitable for medical devices in my country, the State Drug Administration has actively organized some provinces (autonomous regions and municipalities) to carry out research on medical device naming.
In 2010, the former Medical Device Standards Management Center of the State Food and Drug Administration (now the Medical Device Standards Management Center of the State Drug Administration, hereinafter referred to as the Standard Management Center) was established.
One of its responsibilities is to be responsible for the research of medical device naming technology.
The systematic development of naming research provides organizational guarantee.

 

　　After the establishment of the Standardization Management Center, it will conduct in-depth research on the Global Medical Device Terminology System (GMDN) data and related standards, actively participate in the coordination of international medical device naming, and analyze and compare the current status and regulatory policies of medical device naming in the European Union, the United States, Japan and other countries and regions.
In-depth research on the international application of GMDN and the feasibility study of my country's transformation.
On the basis of preliminary research, we systematically sort out my country's regulatory needs, draw on the experience of all parties, and propose plans for my country to establish a medical device naming system composed of regulations and naming guidelines.

 

　　Common names of medical devices are included in the regulations

 

　　The "Regulations on the Supervision and Administration of Medical Devices" revised in 2014 clearly stipulate that medical devices should use generic names; the generic names should comply with the naming rules for medical devices.

 

　　In accordance with the medical device naming system plan, referring to the format and content of the naming rules for drugs, cosmetics , and health foods , and learning from the research results of GMDN, the former China Food and Drug Administration issued the " General Naming Rules for Medical Devices " in December 2015 , since 2016 It will come into effect on April 1, 2015.
As a supporting regulation of the 2014 edition of the "Regulations on the Supervision and Administration of Medical Devices", the "Nambling Rules for the Generic Names of Medical Devices" is my country's first regulatory document for the generic names of medical devices, and puts forward the principled requirements for the naming of the generic names of medical devices.
The rules are clear, and the regulated objects are medical devices sold and used in my country.
Medical devices of the same type that have the same or similar intended purpose and common technology should use the same generic name.
The generic name consists of a core word and generally no more than three characteristic words.
At the same time, it is clear that the core word is a general description of medical devices with the same or similar technical principles, structural composition or intended purpose, and the characteristic words refer to the part where the medical device is used.
, Structural features, technical features or material composition and other specific attributes description.
In addition, the rule also stipulates the prohibited contents in the general names of medical devices, such as models, specifications, graphics, symbols, etc.

 

　　Since the "Rules for the Naming of Common Names of Medical Devices" was implemented in 2016, the original product names that do not meet the requirements of the rules and that there are exaggerations and absolutes have been effectively regulated, which guides all parties to understand the concepts and specifications of the common names of medical devices.
The product name played a leading role.
However, in the practice of formulating generic names, since various types of medical devices do not have clear standardized terms for core words and characteristic words, the registrant/recorder, reviewer, reviewer, pharmnet.
com.
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understand and understand the definitions of core words and characteristic words.
The dimensions are different, and the standards for determining specific terms are not uniform.
As a result, there are still different common names for products of the same variety, which has caused difficulties in the implementation of the "Rules for Naming Common Names of Medical Devices".

 

　　In order to unify the understanding and understanding of the definitions of core words and characteristic words, unify the naming standards, and solve the problem of naming the common names of products in various professional fields of medical devices, as a detailed supplement to the "Medical Device Common Names Naming Rules", the Standardization Management Center is in " During the 13th Five-Year Plan period, research on medical device naming terminology was carried out, and standardized research was carried out on the selection principles of core words and characteristic words in different professional fields, the naming structure of common names, and the words used in word selection.
The "General Names of Medical Devices" was drafted and compiled.
The Guiding Principles provide technical guidance for the formulation of the standardization of the generic names of medical devices.

 

　　The "Guiding Principles for the Naming of Generic Names of Medical Devices" is a technical guidance document, which dynamically adjusts relevant naming terms in accordance with regulatory requirements and technological development to meet the needs of supervision and industrial development.

 

　　 (Author's unit: China Institute for Food and Drug Control)

 

　　Related Links

 

　　Compilation of Guidelines for Naming Common Names in Various Professional Fields of Medical Devices

 

　　□  Mu Ruihong

 

　　Medical device product names involve registration/filing, production, circulation, use and other links.
In order to connect and coordinate with relevant laws and regulations, the Standards Management Center refers to the sub-category field of the "Medical Device Classification Catalogue" released in 2017, and sets up general name naming guidelines.
Domain architecture.
With reference to the procedures for the formulation and revision of the medical device industry standards, the drafting, soliciting opinions, and technical review of the general name naming guidelines have been formulated to lay a foundation for the standardization and standardization of the preparation of the general name naming guidelines.
The Standardization Management Center organizes relevant technical units to draft and compile the "Guidelines for the Naming of Common Names of Medical Devices" and the guidelines for the naming of common names of devices in various professional fields in batches according to the requirements of the procedures.

 

　　The "Guiding Principles for the Naming of Generic Names of Medical Devices" was released in December 2019.
It stipulates the scope of application, and clearly does not include in vitro diagnostic reagents under the management of medical devices; the composition structure and requirements of the generic names are detailed, and the general purpose of each professional field is given.
The guidelines for name naming and the requirements for the compilation of the naming glossary shall explain the commonly used naming terms.
This principle aims to guide and standardize the compilation of guidelines for the naming of common names in various professional fields.

 

　　The guidelines for the naming of common names in various professional fields were formulated in an orderly manner and in batches.
At present, the "Guiding Principles for the Naming of Common Names of Medical Imaging Devices", "Guiding Principles for the Naming of Generic Names of Active Implantable Devices", "Guiding Principles for the Naming of Common Names of Dental Devices" and "Guiding Principles for the Naming of General Names of Orthopedic Surgical Devices", "Blood Transfusion, Dialysis and Guidelines for Naming Generic Names of Extracorporeal Circulation Devices, Guidelines for Naming Generic Names of Passive Surgical Devices, Guidelines for Naming Generic Names of Passive Implant Devices, Guidelines for Naming Generic Names of Medical Devices Sterilization and Sterilization, 8 guidelines have been The formulation work has been completed and will be released in June 2020 and December 2020.
The technical review of 14 guiding principles including "Guiding Principles for Naming Generic Names of Radiotherapy Devices" and "Guiding Principles for Naming Generic Names of Active Surgical Devices" has been completed.

 

　　The guidelines for the naming of common names in various professional fields of medical devices clarify the principles for selecting the core words and characteristic words of products in this field, the naming structure of common names, and the product categories, optional term names and descriptions in the form of a naming glossary, and Typical examples are used to guide the formulation of common names and provide users with a directly searchable "term name set".

 

　　The research on the standardization of the naming terminology of the medical device generic name is not only conducive to guiding and coordinating all parties to the unified understanding and understanding of the generic name of the medical device, and providing technical support for the standardization of the formulation of the unified generic name; at the same time, it is also conducive to the application party to identify the main features of the product.
Data sources, improve the efficiency of review and approval, and lay the foundation for scientific supervision and smart supervision.