Provisions on the Administration of Instructions for Use and Labels of Medical Devices
(CFDA Decree No. 6)
Issued on July 30, 2014
China Food and Drug Administration Decree
No. 6imported food
The Provisions on the Administration of Instructions for Use and Labels of Medical Devices have been examined and passed on the CFDA General Meeting held on June 27, 2014 and now is for publication. The Provisions shall come into effect as of October 1, 2014.
General Director: Zhang Yong
July 30, 2014
Provisions on the Administration of
Instructions for Use and Labels of Medical Devices
Article 1.These Provisions are established in accordance with the Regulation on Supervision and Administration of Medical Devices for the purpose of regulating the instructions for use and labels of medical devices, and ensuring the safe use of medical devices.
Article 2.Medical devices sold or used within the territory of the People's Republic of China shall be accompanied by instructions for use and labels according to these Provisions.
Article 3.Medical device instructions for use is a technical document prepared by registration applicant or filing registrant and provided to user along with the product, which covers basic information of product's safety and effectiveness and is used as guidance for correct installation, commissioning, operation, use, maintenance and care of the medical device.
Medical device labels refer to text descriptions, graphics and symbols attached to the medical device or its packaging for identification of product features and providing safety warnings.
Article 4.Contents of instructions for use and labels of medical devices shall be scientific, true, complete and accurate, and consistent with the product features.
Contents of instructions for use and labels of medical devices shall be consistent with the contents that have been registered or filed.
Contents of medical device labels shall be consistent with contents of the instructions for use.
Article 5.Instructions for use and labels of medical devices shall adopt and use nationwide universal and standard technical terminology and measurement units in their descriptions of disease names, specialty terminology, diagnosis and treatment process and results.
Article 6.Symbols or color identifications used in the instructions for use and labels of medi
cal devices shall be in conformity with requirements of applicable national standards. Symbols or color identifications not included in existing standards shall be clearly described in the instructions for use.
Article 7.The minimum sales unit of medical devices shall be accompanied by the instructions for use.
Users of medical devices shall follow the instructions for use when using the medical devices.
Article 8.Generic name shall be used for the medical device product name, which shall be consistent with the medical device naming rules established by China Food and Drug Administration. Product name of Class II or Class III medical devices shall be consistent with the product name indicated in the Medical Device Registration Certificate.
Product name shall be clearly indicated at conspicuous position of the instructions for use and labels.
Article 9.Text information of instructions for use and labels shall be in Chinese. The use of Chinese language shall conform to national uniform language norms. Other languages may be accompanied in the instructions for use and labels of the medical devices; however the Chinese text shall prevail.
Texts, symbols, tables, numbers, and graphics of the instructions for use and labels of medical devices shall be accurate, clear and standardized.
Article 10.Instructions for use of medical devices shall generally include the following:
(1)    Name, model and specification of product;
(2)    Name, address, contact details and after-sale service providers of registration applicant or filed registrant, and name, address and contact information of agent for imported medical devices;
(3)    Manufacturer's name, address, manufacturing site, contact, production license number or production filing number; if under contracted production, the entrusted company'
s name, address, manufacturing site, production license number or production filing number shall be also indicated;
(4)    The medical device's registration certificate number or filing certificate number;

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