It is a very common phenomenon that medical devices with the words "quasi-drug" are used too much as drugs. It is not allowed to change drugs in hospital pharmacies, but generally in social pharmacies (pharmacies), which is easy to confuse ordinary people taking drugs by mistake.
Some products and even professional pharmacists think that they belong to drugs, but their approval number is indeed the word (quasi) of the US Food and Drug Administration, not the drug approval number.
Regulations on the supervision and administration of medical devices
Article 3 The term "medical devices" as mentioned in these Regulations refers to instruments, equipment, appliances, materials or other articles used alone or in combination, including required software. Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; Its purpose is to achieve the following expected purposes:
(1) Prevention, diagnosis, treatment, monitoring and mitigation of diseases;
(2) Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;
(3) research, substitution and adjustment of anatomical or physiological processes;
(4) Pregnancy control.
For example:
1. Chitosan mouthwash (Kangxi mouthwash): used to inhibit the growth of harmful bacteria in oral cavity and prevent halitosis, gingivitis, oral ulcer and other diseases. As a class II medical device management. Classification code 6863.
2. Chitosan Oral Ulcer Membrane (Kangxi Oral Ulcer Membrane)-composed of polyvinyl alcohol and chitosan. By continuously adhering to the wound surface of oral ulcer, it can block the erosion of oral saliva and oral flora on the wound surface of oral ulcer, and play the role of antibacterial and wound protection. As a class II medical device management.
3. Mouth ulcer mouthwash: composed of maltodextrin, propylene glycol or carbomer. By forming a protective film on the surface of the ulcer, the wound is physically shielded, and the pain caused by minor wounds caused by oral ulcers, oral inflammation, braces or dentures is relieved. As a class II medical device management.
4. Nano silver antibacterial device for external use by women: it is suitable for treating female vaginitis and cervicitis, including: 1) candidal vaginitis, senile vaginitis, bacterial vaginitis, trichomonal vaginitis and mixed vaginitis; 2) Wound healing after physical therapy for chronic cervicitis and cervical erosion; 3) Mycoplasma chlamydia infection and gonococcal infection; 4) Patients with vaginal dryness caused by the above reasons are particularly suitable for lubrication repair. The product consists of nano-silver antibacterial membrane and vaginal drug delivery device. The nano-silver antibacterial membrane is made of nano-silver micropowder and auxiliary materials, and the vaginal drug delivery device is made of high-density polyethylene. Disposable use. The product is used for female to inhibit bacteria in vaginal mucosa and cervix. As a class III medical device management.
5. Nano-silver antibacterial gel: made of nano-silver and medical polymer materials and filled in aluminum-plastic tubes. It is suitable for the adjuvant treatment of infected wounds caused by scalding wounds, mechanical and physical injuries, chronic ulcers on the body surface (compression ulcers, venous ulcers and diabetic lower limb ulcers), superficial fungal diseases of the skin (tinea manus, tinea pedis, tinea corporis and tinea cruris except keratosis), and mild to moderate acne vulgaris. As a class II medical device management.