Some medical devices are valid. For example: condoms; infusion sets, syringes, medical catheters, etc. have the period of validity of disinfection or sterilization; in vitro diagnostic reagents, such as C-reactive protein kit, serum cystatin C test kit, etc.
What kind of management system does China implement for the production of medical devices? Our country implements the license system for the production of medical devices.
The establishment of class II and class III medical device manufacturing enterprises shall be subject to the examination and approval of the provincial food and drug administration, and a medical device manufacturing license shall be issued. The establishment of class I medical device manufacturing enterprises can only be filed with the provincial food and drug administration.
What qualifications do you need to have to operate (sell) medical devices?
To engage in the business activities of medical devices, there shall be business places and storage conditions suitable for the business scale and business scope, as well as quality management systems and quality management institutions or personnel suitable for the medical devices.
Business license and record are not required for the operation of class I medical devices;
To engage in the operation of class II medical devices, it shall be filed with the local food and drug regulatory authorities at the level of city divided into districts;
For the operation of class III medical devices, the operating enterprise shall apply to the food and Drug Administration of the people's Government of the city divided into districts for the operation license, which shall be examined and approved by the food and Drug Administration of the people's Government of the city divided into districts, and shall be issued with the operation license. When a medical device manufacturer sells the medical devices produced by the enterprise, it does not need to apply for business license or record.
What inappropriate publicity should not appear in medical device advertisements?
The publicity of the scope of application, efficacy and other contents in the medical device advertisement shall be scientific and accurate, and shall not appear: containing the assertion or guarantee of efficacy; describing the efficiency and cure rate; comparing the efficacy and safety with other medical device products, drugs or other treatment methods;
In the advertisements of medical devices recommended to individuals, the consumers' weakness of lack of professional and technical knowledge and experience of medical devices shall be used to describe the characteristics or mechanism of the product in terms of specialized terms or unscientific terms beyond the product registration documents; there are so-called "research findings", "experiments or data proofs" which cannot prove its scientificity Content;
Those who violate the laws of science, express or imply that they can cure all diseases and adapt to all symptoms, contain committed terms such as "safety", "non-toxic side effects", "invalid refund", "no dependence", "Insurance Company underwriting", etc., and contain absolutes such as "unique", "accurate", "latest technology", "state-of-the-art science", "national products", "filling domestic gaps", etc Exclusive term; claiming or implying that the medical device is necessary for normal life or treatment of disease;
It contains the contents that express or imply that the medical device can meet the needs of modern tense life, college entrance and examination, can help improve or improve the performance, can make the energy exuberant, enhance the competitiveness, can increase, can benefit the intelligence, etc.