Since the issuance of the "Special Approval Process for Innovative Medical Devices" on February 7 this year, the medical device industry has ushered in another heavy document only after a lapse of more than a month. Yesterday, the Chinese government website announced the revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “New Regulationsâ€). In this regard, Jiang Feng, executive vice president of China Medical Device Industry Association, said that the content of the new regulations is “pleasantâ€. After the release, the industry will loosen the policy. “Under this east wind, China’s medical devices will take a new step. ."
For the release of the new regulations, an industry researcher at a Shenzhen brokerage said that the overall positive is definitely good, because the previous edition was issued in 2000, and many of the content has not adapted to the current situation, restricting the development of the medical device industry. After comparison, the contents of the new regulations include the relaxation of registration review, the establishment of a green channel for review, adjustment of product registration and production site licensing order. "(The new regulations) are more grounded and more in line with international rules." Chen Jian, the director of Yuyue Medical, commented on the new regulations.
The "improvement" that the new regulations are most concerned about by the industry is that the order of product registration and production site licensing will be changed. The product must be registered before the production license is re-registered, and then the product can be registered first and then the production license. This means that medical device companies can focus on product development and listing without having to spend upfront resources on production plant investment, which will greatly ease the financing pressure of SMEs and help innovation.
Insiders pointed out that this improvement of the new regulations provides a good condition for China's medical device research and innovation. At the same time, on February 7, the State Food and Drug Administration issued the "Special Approval Procedure for Innovative Medical Devices (Trial)", giving priority to the approval of innovative medical devices. Overall, the country’s intention to encourage the medical device industry to accelerate innovation is already evident.
In fact, encouraging innovation is an important means to change the current unfavorable status of China's medical device industry with small scale of output value, weak innovation capability and serious homogenization competition. According to Ren Dequan, president of the China Pharmaceutical Business Association, "At present, the development characteristics of China's medical device industry are obvious, small and scattered, with many production enterprises, small enterprises, and the total output value of the medical device industry is more than 180 billion yuan, with an average output value per enterprise. About 12 million yuan, and the average output value of pharmaceutical companies is 140 million yuan."
For the "small, scattered, chaotic" problem, the new regulations have strengthened supervision in terms of industry norms. For the unauthorized production and operation of medical devices, a fine of 20 times the maximum value of goods is stipulated, and penalties for medical device license applications submitted by relevant responsible persons and enterprises are not accepted within five years.
As a result, the new regulations, driven by the two major measures of strengthening supervision and encouraging innovation, have a clear trend in the survival of the fittest, and the pace of mergers and acquisitions will also accelerate. "In the future, leading enterprises will squeeze the living space of small enterprises, and the enterprises with lower rankings will be more likely to be merged." Guojin Securities pointed out in the latest research report.
Creport3500
CrePort 3500 series combined with standard ICU
construction, design proprietary solution according to department and other
special circumstances, can be customized with thie ICU actual condition, fully
meet different environmental needs. All arm length, beam length and column /
head length can be customized.
1. Easy to clean: Antirust and anti-fouling processing, easy to clean.
2. High quality: With high quality material, strong bearing capacity, long
move distance.
3. Convenient operate: Meet with human body engineering, its simple and
flexible operate.
4. High cost-Effective: Full platform accessories configuration, reliable
after-sales service.
ICU Bridge Pendant, Anesthesia Pendant,Ceiling Pendant,Hospital Pendant,Medical Gas Pendant
Shandong Lewin Medical Equipment Co., Ltd. , https://www.lewinmed.com