General Nomenclature Rules for Medical Equipment
General Nomenclature Rules for Medical Equipment
General Nomenclature Rules for Medical Equipment
Order of the China Food and Drug Administration No. 19
December 21, 2015
The General Nomenclature Rules for Medical Equipment, which were adopted at the executive meeting of the China Food and Drug Administration ("CFDA"), are hereby issued for implementation as of April 1, 2016.
Bi Jingquan, Director General of CFDA
General Nomenclature Rules for Medical Equipment
Article 1 In order to strengthen supervision and administration of medical equipment and ensure a scientific and standardized general nomenclature of medical equipment, these Rules are formulated in accordance with the Regulations on the Supervision and Administration of Medical Equipment.
Article 2 These Rules shall apply to medical equipment sold and used within the territory of the People's Republic of China.
Article 3 The general names of medical equipment shall be scientific and explicit, capable of reflecting the product attributes in accordance with relevant national laws and regulations.
Article 4 The general names of medical equipment shall be expressed in the Chinese language in accordance with the national language standards.
Article 5 Medical equipment with identical or similar functions and using identical techniques shall use the same general name.
Article 6 The general names of medical equipment shall consist of a key word and not more than three characteristic words.
The key word shall be a summary description of identical or similar technical principles, structures or functions of medical equipment.
Characteristic words shall be able to describe the specific attributes such as targets of application, structural and technical features or compositions of medical equipment.
......
Order of the China Food and Drug Administration No. 19
December 21, 2015
The General Nomenclature Rules for Medical Equipment, which were adopted at the executive meeting of the China Food and Drug Administration ("CFDA"), are hereby issued for implementation as of April 1, 2016.
Bi Jingquan, Director General of CFDA
General Nomenclature Rules for Medical Equipment
Article 1 In order to strengthen supervision and administration of medical equipment and ensure a scientific and standardized general nomenclature of medical equipment, these Rules are formulated in accordance with the Regulations on the Supervision and Administration of Medical Equipment.
Article 2 These Rules shall apply to medical equipment sold and used within the territory of the People's Republic of China.
Article 3 The general names of medical equipment shall be scientific and explicit, capable of reflecting the product attributes in accordance with relevant national laws and regulations.
Article 4 The general names of medical equipment shall be expressed in the Chinese language in accordance with the national language standards.
Article 5 Medical equipment with identical or similar functions and using identical techniques shall use the same general name.
Article 6 The general names of medical equipment shall consist of a key word and not more than three characteristic words.
The key word shall be a summary description of identical or similar technical principles, structures or functions of medical equipment.
Characteristic words shall be able to describe the specific attributes such as targets of application, structural and technical features or compositions of medical equipment.
......