Medical device labels, packaging identification in the content is to be based on the "Medical Device Instructions and Labeling Regulations" to produce, according to the "Medical Device Instructions and Labeling Regulations" Article VIII: Medical device labels, packaging identification should generally include the following:
1, product name, model, specifications;
2, the name of the production company, registered address, production address, contact information;
3, medical device registration certificate number;
4, product standard number;
4, product standard number Address, production address, contact information;
3, medical device registration certificate number;
4, product standard number;
5, product production date or batch (edited) number;
6, power supply connection conditions, input power;
7, the limited use of the product should be labeled with the expiration date;
8, according to the product characteristics should be labeled with graphics, graphics and other information. Product characteristics should be labeled graphics, symbols and other relevant content.
Article X of the product name of medical devices should be consistent with the corresponding national standards and regulations.
Article XI of the product name of medical devices should be clearly marked in the instructions, labels and packaging identification of a prominent position, and with the certificate of registration of medical devices in the product name.
Article XII of the medical device has a trade name, can be in the instructions, labels and packaging marking at the same time labeling trade names, but should be consistent with the certificate of registration of medical devices labeled trade names. Simultaneous labeling of the product name and trade name, should be divided into lines, shall not be hyphenated, and the medical device trade name of the text shall not be greater than the product name of the text of two times.
Medical device trade names shall not be used to exaggerate, assert the efficacy of the product of the absolutist terms, shall not violate other laws and regulations.
Expanded Information:
According to Article 9 of the "Regulations on the Administration of Instructions and Labeling of Medical Devices," medical device instructions, labels and package markings shall not include the following:
1. p>
1, containing the best therapeutic effect, guaranteed cure, cure, cure, immediate effect, completely free of toxic side effects and other efficacy assertions or guarantees;
2, containing the highest technology, the most scientific, the most advanced, the best, and other absolutist language and representation;
3, the rate of healing or the effectiveness of the rate of cure;
4, and other enterprises the efficacy of the product and the safety of comparison;
4, with the products of the efficacy and Comparison with the efficacy and safety of other companies' products;
5, containing insurance companies, invalid refunds and other promising language;
6, the use of any unit or individual's name, image as a proof or recommendation;
7, containing a feeling that a person has suffered from a disease, or make people misunderstand that not using the medical device will suffer from a disease or aggravate the condition of the expression;
8, laws and regulations provide for the use of the medical device, the use of medical equipment and other absolute language and representation;
How to use medical equipment and other products? p>8, laws and regulations prohibit other content.
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