(2) Absolute wordings and expressions such as \
\(3) Indicating cure rate or effective rate;
(4) Making product effectiveness and safety comparison with products of other enterprises; (5) Carrying commitment words such as \(6) Endorsements or recommendations using names or images of any organizations or
individuals; (7) Misleading statement making people feel they are already suffering from certain disease, or
giving them an impression that they would suffer from certain disease or their illness would aggravate if not using this medical device; (8) Other contents prohibited by laws and regulations.
Article 15. Instructions for use of medical devices shall be submitted to food and drug administration
authority for examination or filing when the registration applicant or filing registrant is applying for registration or filing for the medical devices, and the submitted instructions for use shall be consistent with other registration or filed information. Article 16. Upon registration examination by the food and drug administration authority, the
instructions for use of medical devices shall be not changed arbitrarily.
In case there is change of registration with the registered medical device, the applicant shall, upon obtaining the change document, amend the instructions for use and labels in accordance with the change document.
In case there are changes with the other contents of the instructions for use, the applicants shall notify the medical device registration examination and approval authority in writing and submit comparison matrix of amendments to the instructions for use as well as other supporting
documents. If no denial notice regarding the instructions for use amendment is received within 20 working days from the examination and approval authority after such amendment notification has been served, the amended instructions for use shall become effective.
Article 17. For a filed medical device, if there are changes with the items of filing information form,
filed product technical requirements or other contents of the instructions for use, the filing registrant shall amend the instructions for use and labels accordingly. Article 18. In the circumstances where the instructions for use or labels are in violation of these
Provisions, the food and drug administration departments above county level shall impose
penalties/fines in accordance with Article 67 of Regulation on Supervision and Administration of Medical Devices. Article 19. These Provisions shall come into effect as of the date of October 1, 2014. The Provisions on
the Administration of Instructions for use and labels of Medical Devices published on July 8, 2004 (SFDA Decree No. 10) shall be abolished at the same time. Article 20.
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