Some medical devices have an expiration date. Such as: condoms; infusion sets, syringes, medical catheters, etc. have a validity period of disinfection or sterilization; in vitro diagnostic reagents, such as C-reactive protein kit, serum cystatin C determination kit, etc.
What kind of management system does China implement for the production of medical device products? China implements a licensing system for the production of medical device products.
The establishment of second- and third-class medical device manufacturing enterprises shall, upon examination and approval by the provincial food and drug supervision and administration department, issue medical device production licenses. To set up a first-class medical device manufacturing enterprise, it may be filed with the provincial food and drug supervision and administration department.
What qualifications are required to operate (sell) medical device products?
To engage in medical device business activities, there must be a business place and storage conditions that are compatible with the scale and scope of the business, as well as a quality management system and quality management agency or personnel that are compatible with the medical device being operated.
The operation of the first type of medical devices does not require a business license and filing;
To engage in the operation of second-class medical devices, they shall file a record with the municipal food and drug regulatory department with the district where they are located;
In the third category of medical device business, the operating enterprise shall apply for a business license to the food and drug supervision and administration department of the municipal people's government in the district where it is located. Device business license. Medical device manufacturing companies selling medical devices produced by their own companies do not need to apply for a business license or file a record.
What are the legal requirements for selling medical device products online?
The sale of medical devices online should comply with the "Administrative Measures for Internet Drug Information Services." When consumers purchase medical devices online, they should check the "Internet Drug Information Service Qualification Certificate" and "Internet Drug Trading Service Qualification Certificate", and check the Internet drug trading service qualification certificate number on the homepage of the website. How can I report a complaint after I find that the medical device is fake? Consumers who report fraudulent medical devices, use product without a product registration certificate, or use medical devices beyond their validity period can report a complaint to the Food and Drug Administration at the county level or above, or call the complaint report phone: 12331.
What is the legal basis for the review of medical device advertisements? The legal basis for the review of medical device advertisements is the Advertising Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Review of Medical Device Advertisements, the Standards for the Review of Medical Device Advertisements, and relevant national regulations.