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

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"

Standardizing the generic names of medical devices plays a very positive role in the supervision of medical devices

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

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.

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