Analysts pointed out that benefiting from the development of the economic level, the health demand is increasing, and China's medical device market has ushered in huge development opportunities
.
Throughout 2022, China's medical device industry is steadily progressing, and the industrial scale continues to grow at a high rate
.
According to relevant statistics, from 2015 to 2021, the average annual compound growth rate of China's medical device industry operating income (above + below the regulations) is 10.
65%, that is, from 629.
7 billion yuan to 1,156 billion yuan
.
It is estimated that the operating income of China's medical device industry may reach 1.
3 trillion yuan in 2022, a year-on-year increase of about
12%.
China's medical device market has maintained a rapid growth trend
driven by terminal clinical demand, policy support, import substitution, etc.
According to statistics, the scale of China's medical device market in 2021 increased by 27.
6% year-on-year, reaching 964 billion yuan, and it is estimated that the market size will reach 1,171 billion yuan
in 2022.
At the same time, the number of domestic medical device product registrations has also developed
steadily.
According to data from the State Food and Drug Administration, in 2022, the State Food and Drug Administration approved the registration of a total of 2,500 medical device products
.
In December 2022 alone, the NMPA approved the registration of 339 medical device products
.
Among them, there are 273 domestic Class III medical device products, 37 imported Class III medical device products, 25 imported Class II medical device products, and 4 Hong Kong, Macao and Taiwan medical device products
.
In addition, according to statistics, in 2022, the number of first-time registrations of domestic Class III medical device products increased by 63.
04% year-on-year, reaching 1,844; The number of first-time registrations of Class II medical devices in China reached 13,334; The number of new filings for Class I medical device products in China reached 29,807
.
From the perspective of the distribution of subdivisions, the two fields
with the largest number of first-time registrations of medical device products in China in 2022 are in vitro diagnostic reagents (accounting for 17.
2%) and passive implantable devices (accounting for 21.
7%).
From the perspective of the growth of the number of medical device manufacturers, in recent years, the number of medical device manufacturers in China has grown rapidly
.
Among them, it exceeded 30,000 in 2022 and reached 31,503 as of September 2022
.
According to the category of medical device products, in 2022, there will be 19,025 enterprises that can produce first-class medical device products, with rapid growth; There are 14,119 enterprises that can produce Class II medical device products, with steady growth; There are 2,412 enterprises that can produce three types of medical device products, with rapid growth
.
Analysts pointed out that in recent years, with the support of national policies and the increasing health needs of the people, China's medical device industry is continuing to grow
rapidly.
And with the blessing of favorable policies, the technological iteration of domestic medical device manufacturers, and the promotion of medical insurance control fees, import substitution has become an important development trend
of the domestic medical device industry.
For example, on the policy side, the State Council and the Food and Drug Administration have issued many documents to support the development of the domestic medical device industry, especially to encourage the accelerated listing of products that are urgently needed and innovative;
On the payment side, on the one hand, medical insurance control fees and centralized procurement squeeze out space for the development of the medical device industry, on the other hand, because international medical device manufacturers need to consider the problem of global market price synchronization, the extrusion effect of domestic medical insurance control fees and centralized procurement on international medical device manufacturers is more obvious
.
In addition, the rapid growth of the domestic medical device market and the large space for market expansion are conducive to promoting the rapid expansion of domestic medical device enterprises and the substitution
of imported products.
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