1. What is a medical device?
Medical devices refer to instruments, equipment, appliances, materials, software or other items used alone or in combination for the prevention, diagnosis, treatment, monitoring, and compensation of human diseases.
The biggest difference between medical devices and drugs: the effects on the body surface and in the body are obtained by physical means, rather than by pharmacological, immunological or metabolic means.
2. How do medical devices and daily necessities differ?
Medical device products are subject to strict approval for registration or filing. Whether it is a medical device or not, it is necessary to see whether there is a medical device registration certificate number or a record number on the product packaging, such as “Zhejiang Food and Drug Administration (Quasi) word 2009 No. 2630558”. The medical device products and registration certificate number that have been approved for registration or filing can be found on the website of the State Food and Drug Administration. Health care products or daily necessities are not medical devices.
If it is not a medical device, there should be no therapeutic function and curative effect in the propaganda, and the words "treatment, cure XX disease" should not appear in the product manual.
3. What issues should I pay attention to when purchasing medical device products?
(1) It should be confirmed whether the product is marked with the medical device registration certificate number. If in doubt, it can be inquired on the website of the State Food and Drug Administration.
(2) It should be confirmed that the product registration certificate has not expired. The medical device registration certificate is valid for 4 years. When the consumer checks the certificate, in addition to confirming the authenticity, it should also confirm whether the certificate is within the validity period.
(3) For products such as contact lens care solution, the product itself is required for the validity period. At the time of purchase, consumers should pay attention to check whether the product has expired.
(4) Pay special attention to confirm the scope of application of the product during the purchase, especially for some therapeutic instruments. The scope of application of medical device products is an important part of the pre-market approval. However, in the distribution process, some vendors exaggerate the scope of application.
For some common chronic diseases, such as hypertension and diabetes, the food and drug supervision and administration department has not yet approved medical device products that can cure such diseases. If during the sales process, the merchant claims to be able to “cure” or “cure” diseases such as high blood pressure and diabetes, or claim to be able to replace the drug treatment, consumers should be alert to avoid being deceived.
(5) Try not to buy medical device products through online shopping.
(6) Do not purchase “three no” products without a production company name, no production address, and no contact information.