How are Class I, II and III medical devices classified?

Class I, II and III medical devices are categorized according to their safety of use.

Class I refers to medical devices whose safety and efficacy can be guaranteed through routine management. Generally by the City Food and Drug Administration to approve the registration certificate issued.

The second category refers to its safety and effectiveness of medical devices should be controlled. Generally by the Provincial Food and Drug Administration to approve the registration certificate issued.

Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Generally by the State Food and Drug Administration to approve, issue a registration certificate.

Medical beauty is a direct use of drugs, devices acting on the human body, there is a great security risks. Therefore, medical products need to undergo rigorous clinical trials, get regulatory approval before entering the market.

Medical aesthetic products belong to Class III medical devices, is the highest level of medical devices, its safety, effectiveness must be strictly controlled.

From the perspective of research and development, it usually takes more than 5 years from project to market.

Characteristics of the medical beauty industry:

(1) high barriers

This is said to be a regular business. At present, the threshold of entry into the industry is relatively low, mixed stage, the rise of the concept. New things, there will be this stage.

(2) monopoly

Leading companies monopolize the market, accounting for a high proportion.

(3) Long life cycle

From adolescence to old age, there is demand, especially in the 20-40 years old stage, the consumption ability is strong

(4) Customer stickiness

As long as you have enjoyed the medical beauty, you can not stand the "ugly" moments

(5) Timeliness

(5) The product is not the most important.

The product is not used once to complete, injection of hyaluronic acid will be repeated in a few months to inject, increase the frequency of consumption

(6) set of immunity

Although it is a medical device, but does not belong to the scope of treatment of diseases, set of inaccessible, corporate pricing power, profits.