《医疗器械说明书、标签和包装标识管理规定》(局令第10号)_EN

Provisions for Instructions, Labels and Packages for Medical Devices

(SFDA Order No. 10)

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Order of the State Food and Drug Administration

No. 10

The “Provisions for Instructions, Labels and Packages for Medical Devices” passed by the State Food and Drug Administration at the administrative affairs meeting of June 18th of 2004 are hereby promulgated and shall go into effect as of the promulgation date.

Xiaoyu Zheng, Director - General

July 8, 2004 Provisions for Instructions, Labels and Packages for Medical Devices

Article 1 The present provisions are stipulated in accordance with the Regulations for the Supervision and Administration of Medical Devices to standardize the instructions,

labels, and packages for medical devices and to ensure the safe use of medical devices.

Article 2 All of the medical devices that are sold and used in the territory of the People’s Republic of China shall have instructions, labels, and packages in accordance with

the present provisions. For products that are simple and easy to use, one or two of the

three items, namely instructions, label or package, can be omitted according to the

regulations of State Food and Drug Administration; the regulations are to be followed

accordingly.

Article 3 Users of a medical device shall use the medical device in accordance with the instructions for the medical device.

Article 4 The term “instructions for a medical device” refers to the technical document that is prepared by the manufacturer and provided to the consumer together with the

product, covering the basic information concerning the safety and efficacy of the said

product, which is used as the directions for the correct installation, adjustment,

operation, use, maintenance and repair of the device.

The term “label of a medical device” refers to the written descriptions, figures, and

symbols that are attached to the medical device or the package and used for

identifying the special features of the product.

The te rm “package of a medical device” refers to the written descriptions, figures,

and symbols on the package that reflect the main technical features of the medical

device.

Article 5 The contents of the instructions, label, and package for a medical device should be truthful, complete, accurate, scientific and consistent with the special features of the

product.

The contents of the label and package of a medical device should be consistent with

those of the instructions.

Article 6 The contents of the instructions, label, and package for a medical device must be in Chinese; other languages can be added. The use of the Chinese language should be

consistent with national language norms.

The writing, symbols, figures, tables, numbers, photographs, graphs, etc. of the

instructions, label, and package for a medical device should be accurate, clear, and

standard.

Article 7 The instructions for a medical device should comply with national standards or industry standards and should normally include the following contents:

(1)The product name, model number, and specifications;

(2)Name of the manufacturer, registered address, manufacturing address, means

of contact, and the department of after-sale service;

(3)Licence number of the “Medical Device Manufacturer Licen c e” (except for

category one medical devices) and certificate number of the Medical Device

Certificate of Registration;

(4)The product’s standard serial number;

(5)The product’s function, main structure, and scope of application;

(6)Contraindications, precautions and other content requiring warnings or

reminders;

(7)Explanations of the figures, symbols, abbreviations, etc. used in the label of the

medical device;

(8)Instructions or diagrams for installation and use;

(9)Method of maintenance and repair of the product, special storage conditions

and methods;

(10)For products with an expiry date, the shelf life (period of stability) should be

indicated;

(11)Other contents specified in the product standards that should be indicated in the

instructions.