Recently, the CFDA official website issued the "General Terms and Conditions for Medical Devices" (hereinafter referred to as "naming rules") (Order No. 19 of the State Food and Drug Administration). It is reported that the "Nomenclature" was reviewed and approved at the State Food and Drug Administration's Bureau meeting on December 8, 2015, and will be implemented as of April 1, 2016.
Standardizing the generic name of medical devices is essential for accurate identification and proper use of medical devices, and is an important basic work for the registration and supervision of medical devices. The introduction of naming rules can standardize the word structure and banned words existing in the current product name, and solve the problems of confusion and misleading identification of medical device names caused by inaccurate naming and unscientific.
Therefore, CFDA draws on the construction of the Global Medical Device Terminology System (GMDN), and refers to the requirements and practices of medical device naming in the United States, the European Union, Japan and other countries and regions, based on the format and content of the generic name of the drug, The survey and extensive consultations were conducted, and the naming rules were formulated.
As a supporting regulation of the Regulations on the Supervision and Administration of Medical Devices, the Nomenclature is the first regulatory document for the generic name of medical devices. The promulgation of the "National Rules" marks that China's medical device generic name naming work has entered the track of legal compliance, which is of great significance for perfecting China's medical device regulatory system and consolidating the regulatory basis.
Ten items, six key points
There are a total of ten naming rules, which mainly include the following aspects:
First, it is clear that the legislative basis for the "National Rules" is the "Regulations on the Supervision and Administration of Medical Devices". The scope of application is medical device products that are marketed and used in China. The normative object is the generic name of medical devices.
Second, it is clear that the principles for the naming of generic names of medical devices should be legal, scientific, clear, and truthful. They should use Chinese and conform to the national language and characters.
Third, the content requirements and composition of the generic name are clarified. The same generic name should be used for the same variety of medical devices with the same or similar intended purpose and common technology; the generic name consists of a core word and generally no more than three features. The word composition, and the contents of the core words and feature words are explained.
Fourth, the prohibited content of the generic name is clarified. The generic name must not contain “model, specificationâ€, “graphics, symbols, etc.â€, “personal name, company name, registered trademarkâ€, except for the corresponding requirements stipulated in the “Nomenclatureâ€. Or 9 similar prohibitive requirements such as “absolute, unique, precise, quick-acting, absolute, exclusive words†and “words indicating efficiency and cure rateâ€.
Fifth, the other contents related to the generic name are clarified, and the generic name may not be registered as a trademark; the naming of the in vitro diagnostic reagents for medical device management shall be carried out in accordance with the provisions of the General Administration's Order No. 5.
Sixth, taking into account the need for publicity training and related preparatory work after the release of the regulations, the date of implementation is determined to be April 1, 2016.
Medical device generic name naming rules
The first is to strengthen the supervision and management of medical devices, to ensure the scientific name and standardization of the generic name of medical devices, and to make these rules in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 All medical devices sold and used within the territory of the People's Republic of China shall use the common name, and the naming of the common name shall comply with these Rules.
Article 3 The generic name of a medical device shall comply with the relevant laws and regulations of the State, be scientific and clear, and be consistent with the true attributes of the product.
Article 4 The generic name of medical devices shall be in Chinese and conform to the national language and characters.
Article 5 The same generic name shall be used for medical devices of the same variety that have the same or similar intended purpose and common technology.
Article 6 The generic name of a medical device consists of a core word and generally no more than three characteristic words.
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