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    Home > Medical News > Latest Medical News > Standardize the naming of medical device products and speed up the formulation of relevant guidelines

    Standardize the naming of medical device products and speed up the formulation of relevant guidelines

    • Last Update: 2021-07-28
    • Source: Internet
    • Author: User
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    The 2014 revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") formally put forward the concept of generic names for medical devices; the "Nambling Rules for the Common Names of Medical Devices" (hereinafter referred to as "Naming Rules") implemented in 2016 put forward The basic requirements for the generic name of medical devices have been introduced
    .


    Regarding pre-marketing review, post-marketing supervision, or manufacturing companies, standardizing the naming of medical device products is of great significance
    .


    Canonical naming has far-reaching significance

    The concept of generic names for medical devices comes from the 2014 revised "Regulations", but there has been a long history of thinking about the naming of medical devices, and standardized naming is a constant demand for the development of the medical device industry and scientific supervision
    .


    The meaning of the common name is to ensure that "same name and same thing, same thing and same name"
    .
    The so-called "same name and same substance" means that medical devices with the same product name should be of the same type, and there should be no situations where several completely different medical devices use the same or similar names; while "same substance with the same name" refers to the same type of product.
    Different types of products should have the same name, and there should not be multiple names of the same medical device with different forms and contents

    .
    In daily work, the problem of "same name with different things" is relatively rare, and only occurs in very rare cases, and it is usually not a cause of ambiguity in understanding, and rarely causes regulatory errors; the problem of "same thing with different names" It is more common.
    For commercial purposes or other factors, manufacturers often hope that their products can have ingenious names.
    This has led to a large number of similar products being given different product names

    .


    Standardizing the generic names of medical devices plays a very positive role in the supervision of medical devices
    .
    On the one hand, it helps to unify the evaluation and supervision standards, and on the other hand, it can effectively prevent enterprises from conducting informal publicity for commercial purposes

    .


    Learn from the experience of drug naming supervision

    The “Notice on the Implementation of the “Regulations for the Naming of Common Names of Medical Devices” issued by the State Drug Administration in 2016 requires that review agencies regulate product names when conducting technical reviews of medical devices
    .
    As the "Nomenclature" only puts forward the principled requirements for naming work, and does not give standardized terms, in actual work, the reviewers can only make suggestions in accordance with the principles, and there is no specific entry that can be referred to

    .
    This leads to greater difficulty in naming

    .
    In addition, the name of medical device products is not only an issue in the field of medical supervision, but also involves many fields such as hygiene, bidding, procurement, and marketing, which also increases the difficulty of the development and promotion of medical device naming and generic names

    .


    The supervision of the generic names of medical device products has borrowed from the supervision of drugs to a certain extent, which has both reasonableness and shortcomings for the supervision of medical devices
    .


    The reason why the generic name is used in drug supervision is that the composition of the drug is relatively certain.
    The same type of medicine is composed of the same and certain components, and the medicines with different components are different varieties

    .
    Therefore, the use of ingredients and chemical formulas as generic names of drugs can effectively distinguish and identify drug varieties

    .
    However, for medical devices, the functions and structures of the same type of products may be slightly different, and similar products produced by different manufacturers will also have their own characteristics.
    This is a significant difference between medical devices and drugs

    .
    The "Nomenclature" stipulates that the structure of the general name of medical devices is composed of a core word and generally no more than three characteristic words

    .
    Common names are used as the naming method for medical devices.
    Under the regulation that the number of characteristic words is limited, it is inevitable that there will be differences between two products with the same name

    .
    However, reasonable naming methods, appropriate core words, and targeted selection of characteristic words can minimize the above-mentioned differences and basically realize the "same name and same thing, same thing and same name" required by medical device supervision

    .


    Trade names are also derived from the field of drug regulation
    .
    There is a concept of trade name in drug name supervision.
    The main reason is that the chemical name as a generic name of a drug is too obscure and difficult to promote and use (especially OCT drugs for the general public).
    Therefore, an easy-to-understand but not easy-to-understand drug is needed.
    Commercialized names that can cause misleading publicity are used as "code names" for drugs

    .


    Before the 2014 revision of the "Regulations" was issued and implemented, the concept of brand names also existed in the field of medical device supervision.
    However, due to the differences between the characteristics of medical devices and drugs, although the naming contains some professional terms, it is generally easy to understand.
    In this case, the trade name is not mandatory, so many products did not reflect the trade name when they were approved for registration

    .
    In addition, under the old legal system, manufacturers also have misunderstandings about trade names, resulting in a wide variety of trade names for registered products

    .
    After the 2014 revision of the "Regulations" was promulgated and implemented, it no longer reflects any regulatory provisions related to trade names, but treats trade names as the commercial behavior of manufacturers

    .


    Orderly development of guiding principles

    Currently, work on the guidelines for medical device naming is progressing.
    The guidelines for general naming and some specific product guidelines have been released, and the naming guidelines for multiple products are also being drafted or solicited for comments

    .
    These specific guidance documents can play a positive role in promoting the implementation of the "Nomenclature Rules" and provide a strong basis for the determination of the generic names of medical devices

    .


    There are many types of medical devices, and different medical devices have their own characteristics.
    Although the guidelines and terminology cannot be exhaustive and cover all products, they can play a very good role in regulating most of the current products

    .
    In view of the uniqueness of medical devices, the naming work (especially the determination of the naming term set in the specific product guidelines) is difficult, and it needs to be considered from many aspects: it is necessary to select the most accurate core term and terminology.
    Take into account the number of characteristic words and the difficulty of selection; not only cover the types and characteristics of all medical devices, but also choose the most prominent characteristic words; not only ensure the scientificity of the terminology, but also take into account the current status of the registered products

    .
    It is believed that with the joint efforts of personnel in different regulatory fields, the supervision of medical device naming will continue to move forward and gradually standardized and improved

    .


    Source/ China Medical News

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