Legal analysis: A Food and Drug Administration in the supervision and inspection found that the B medical device business company operating in the C factory production of medical electronic thermometer (medical device registration certificate No.: × mechanical note quasi 201622000 × × ×) manual labeling "storage conditions: -20 ° C ~ 55 ° C, humidity 10% ~ 93% ". The registration certificate indicates that the product technical requirements of the product as "×械注准201622000××", ×械注准201622000××, ×械注准201622000××the technical requirements of the product is based on the GB/T21416-2008 "medical electronic thermometer" compilation, the technical requirements of the product is clear that "Packaged thermometer should be stored in relative humidity not more than 85%, no corrosive gases and well-ventilated room".
Legal basis: "Medical Device Instructions and Labeling Regulations" Article 14 of the medical device instructions and labels shall not have the following content:
(a) Containing "the best therapeutic effect", "guaranteed cure", "cure", "cure", "instant effect", "no toxic side effects" and other assertions of efficacy
(b) contains "the highest technology", "the most scientific", "the most advanced", "the best" and other absolutist language and "the best".
(ii) contains absolute language and expressions such as "the highest technology", "the most scientific", "the most advanced", "the best", etc.;
(iii) states the cure rate or effective rate;
(iv) compares with the efficacy and safety of the products of other companies;
(v) contains the words "insured by the insurance company", "refunded if not effective", "ineffective refund" and other promising language;
(F) the use of any unit or individual's name, image as a proof or recommendation;
(G) contains misleading statements that make people feel that they have suffered from a certain disease, or mislead people into believing that they will suffer from a certain disease or aggravation of the condition if they don't use the medical equipment Expressions, and other false, exaggerated, misleading content;
(H) laws and regulations prohibit other content.