The introduction of the new edition of the "Regulations on the Supervision and Administration of Medical Devices" may be just beginning, and the medical device industry decree is brewing a larger "update". On Wednesday, an official of the Jiangsu Food and Drug Administration revealed that there are still 30 or so ministerial-level regulations in the research and development, and it is expected to be introduced intensively in the past two years. "The regulations to be introduced involve all aspects of the life cycle of medical devices, which will have a very large impact on the market and corporate marketing systems. The impact is expected to be reflected in the next two years," said the official. He revealed that the upcoming regulations will cover the research, development, production, distribution and use of medical devices. The research and development process includes the introduction of high-risk medical device catalogues, the establishment of clinical review procedures, the approval of medical device clinical trial institutions, and the special review of innovative medical devices. Evaluation procedures, etc.; production links include GMP certification; circulation includes Internet sales, third-party logistics and business quality management practices; use links include the development of a yellow-black list, full-scale electronic supervision, adverse event monitoring and product recalls. Different from drug supervision, domestic supervision of medical devices is not widespread, management is rough, and regulatory information is not connected, making it difficult to implement strict supervision on quality and price. Since last year, the state has gradually started to implement stricter supervision on the price and use of medical consumables by organizing centralized bidding and procurement of provincial high-value consumables.
According to the site of fungal infection,it can be divided into superficial fungal infection and deep fungal infection, superficial fungal infection is caused by ringworm infection of the skin, hair, fingers, toe fingers. The incidence rate is high with less harmful. Deep fungal infection is caused by Candida and cryptococcal invasion of internal organs and deep tissue, the incidence is low with big harmful. Classified based on mechanism action classification can be divided into (1) Antifungal agents for sterol synthesis in fungal cell membranes (2) Antifungal agents for fungal cell wall synthesis (3) Antifungal agents acting on nucleic acid synthesis, The Antifungal drugs easily affect the white blood cells and liver function, if in long-term use,it may caused a transient increase in GPT or leukopenia, withdrawal is normal.
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