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Recently, the Medical Device Technical Evaluation Center of the State Food and Drug Administration issued the "Guidelines for the Registration Review of Artificial Shoulder Joint Prosthesis (Draft for Comments)" to solicit comments
from the public.
According to the consultation draft, the guiding principles are intended to guide registration applicants in the preparation and writing of registration application materials for artificial shoulder prostheses, and also provide reference
for the technical review department to review the registration application materials.
In China, the artificial shoulder joint market has broad development space driven by huge demand, and local enterprises need to further improve their R&D and innovation capabilities to break through the technical bottleneck
as soon as possible.
Technical problems to be solved Artificial shoulder joints mainly include humeral components (such as humeral head, humeral stem, humeral pad, humeral tors, etc.
), glenoid components (such as shoulder glenoid pads, shoulder glenoid bolsters, shoulder glenoid heads, fixing screws, etc.
), usually made
of cobalt-chromium-molybdenum alloy, titanium alloy, ultra-high molecular weight polyethylene and other materials.
Artificial shoulder arthroplasty includes three types
: artificial humeral head replacement (also known as artificial hemishoulder arthroplasty), total artificial shoulder arthroplasty and artificial shoulder joint replacement.
This type of surgery occupies an important position
in the treatment of joint diseases such as shoulder osteoarthritis, rheumatoid arthritis, comminuted humerus fracture of the proximal humerus, avascular necrosis of the humeral head, and irreparable rotator cuff tear.
Studies have shown that the excellent follow-up results of early and intermediate (within 10 years) of total shoulder replacement can reach more than 90%; The prosthetic survival rate for patients under 50 years of age after prosthetic hemi-shoulder replacement is about 82%, and the prosthetic survival rate at 20 years after surgery is about 75%.
Although the survival rate of prosthesis after artificial shoulder replacement is at a high level, it is consistent with the problems existing in artificial hip and knee arthroplasty, and prosthesis wear and loosening are common problems after surgery, and revision surgery is difficult
.
Although the research starting time of artificial shoulder replacement is not much different from that of artificial hip joint and artificial knee joint, due to the complex structure of artificial shoulder joint, large range of motion, and high replacement requirements, the long-term replacement effect of artificial shoulder joint is not as good as artificial hip joint and artificial knee joint
.
According to medical equipment data cloud statistics, at present, there are nearly 20 artificial shoulder joint products approved for marketing in China, and the proportion of domestic brands is still lower than that of foreign brands
.
Local enterprises that have obtained the registration certificate of artificial shoulder joint products include Beijing Chunli Zhengda Medical Equipment Co.
, Ltd.
, Kuanyue Xinsheng Shi Medical Technology (Shanghai) Co.
, Ltd.
, Shanghai Puwei Medical Equipment Factory Co.
, Ltd.
, Beijing Youcai Jinghang Biotechnology Co.
, Ltd.
, etc
.
It is believed that with the continuous increase of investment in the research and development of artificial shoulder joint products by related enterprises, the above technical problems will be effectively solved
.
The "Guidelines for the Registration Review of Artificial Shoulder Joint Prostheses (Draft for Comments)" pointed out that according to the "Classification Catalogue of Medical Devices", artificial shoulder joints belong to the third class of medical devices and belong to orthopedic implantable medical devices
.
According to data released by Minenet and other institutions, it is estimated that by 2024, the market size of orthopedic implantable medical devices in China is expected to reach 60.
7 billion yuan, with an average annual compound growth rate of about 14.
51%
from 2019 to 2024.
Artificial joint implantable medical devices are one of
the fast-growing segments of orthopedic implant medical devices in the market.
According to the research reports of Intranet and other institutions, from 2015 to 2019, the market size of artificial joint implantable medical devices in China has increased from 4 billion yuan in 2015 to 8.
6 billion yuan in 2019, with an average annual compound growth rate of 20.
65%; The market size is expected to reach 18.
7 billion yuan by 2024 (see chart for details).
As an important branch of the artificial joint implant device market, artificial shoulder joint is also expected to develop
at a rapid growth rate.
In addition, in recent years, the aging of China's population has intensified and the demand for medical care has been increasing, which has promoted the rapid growth of the market scale of orthopedic implant medical devices in China
to a certain extent.
According to data from the National Bureau of Statistics, from 2015 to 2020, the number of people aged 60 and over in China has increased from 231 million to 267 million, accounting for 16.
70% to 18.
90%
of the total population.
It is foreseeable that with the increase in the number of elderly people in China, the market demand for orthopedic implanted medical devices such as artificial shoulder joints will be further released
.
(Contributed by Zhongcheng Medical Equipment Research Institute)
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