Why Does My Country Require Higher and Higher Requirements for Three Types of Medical Device Regulat
Author：MeCan Medical–ultrasound machine manufacturers
As a high degree of risk ZUI, the three types of medical devices are highly controlled by the human body, which should be more stringent and controlled. Therefore, the importance of enterprises to apply for three types of business licenses for medical devices is self -evident! Why do medical device regulations require higher and higher and higher?
1. The need for Chinese medical reform
According to the "Opinions on Deepening the Reform of the review and approval system for deepening review and approval system, encouraging the innovation of pharmaceutical and medical equipment", my country has continuously released many related reforms, such as the "47" band procurement, the "China Drug Administration Law", "China Vaccine" Management Law, New Pharmacopoeia and so on. In order to follow up this reform, the principles of various medical device guidance have been frequently introduced to regulate the industry.
2. The regulatory environment in the pharmaceutical industry is becoming more and more standardized
In order to follow up the regulations of medicine, in the first half of 2020, NMPA issued related regulations documents and announcements and the total number of announcements was almost equivalent to the relevant release of the year in 2019, which also promoted the more mature and standardized regulations for medical devices.
3. The market itself is growing in the medical device industry
From 2011 to 2021, the exports of my country's medical instruments and instruments increased year by year, and due to the impact of this epidemic, the demand for medical devices in foreign markets increased, increasing the export volume of domestic medical instruments. Therefore, in order to meet the requirements and improvement of my country's medical devices in Europe and the United States, my country has proposed more regulations and guidelines in this regard to improve its standardized management.
4. More companies join the medical device industry
Due to the rapid development of Chinese medical device in the past two years, the large demand for markets at home and abroad has led more companies to join the medical device industry, and more and more employees have been joined.
5. In recent years
In recent years, there have been more and more medical device accidents. The Guo family has also released related documents such as the "Basic Principles of the Safety and Performance of Medical Device" to enhance the safety and stability of the equipment, thereby reducing the incidence of related accidents.
In summary, my country's attention and requirements for medical devices will become higher and higher. Therefore, it is both opportunities and challenges for medical devices. Are you ready to operate three types of medical devices?
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