For example
1: Chang Food and Drug Administration (Approval) No. 2010 1260011 is a class of medical device. The distinction is 1 (1260011), which is a category.
2: Zhejiang Pharmaceutical Regulatory Equipment (quasi) No. 2002 2640339 is a Class II medical device. The distinction is 2 (2640339) and 2 is the second category.
3: The National Food and Drug Administration (Approval) No. 2007 No. 3400852 is a Class III medical device. The distinction is 3 (3400852) and 3 is the third category.
The state implements classified management of medical devices according to risk levels.
The first category is medical devices with low risk, and routine management can ensure their safety and effectiveness.
The second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness.
The third category is medical devices that have higher risks and require special measures to be strictly controlled and managed to ensure their safety and effectiveness.
Commonly used drugs and medical equipment
Home health care equipment: pain massage equipment, home health care self-testing equipment, blood pressure monitors, electronic thermometers, multi-function therapeutic devices, laser therapy devices, blood sugar devices, diabetes treatment devices, vision improvement equipment, sleep improvement equipment, oral hygiene products, and home emergency treatment products.
Household health massage products: electric massage chairs/beds; massage sticks; massage hammers; massage pillows; massage cushions; massage belts; blood circulation machines; foot baths; foot massagers; handheld massagers Devices, massage bathtubs, fat-removing belts; therapeutic devices; foot therapy devices; slimming belts; car seat cushions; kneading pads; massage chairs; breast enlargement devices; beauty massagers.
Home medical rehabilitation equipment: household cervical and lumbar traction devices, traction chairs, physiotherapy instruments, sleep instruments, massagers, functional chairs, functional beds, supports, medical inflatable air cushions; oxygen concentrators, medicine decoction devices , hearing aids, etc.
Home care equipment: home rehabilitation care auxiliary devices, women's pregnancy and baby care products, home feeding and gas delivery equipment; oxygen bottles, oxygen bags, home first aid kits, blood pressure monitors, blood glucose meters, nursing beds .
Commonly used medical equipment in hospitals: trauma treatment vehicles, operating beds, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, microplate readers, plate washers, urine Analyzers, ultrasound machines (color ultrasound, B-ultrasound, etc.), X-ray machines, MRI, etc.
New medical devices
With the development of science and technology, the scientific and technological achievements of some colleges and universities have also been rapidly transformed into results. Patented products produced by some new manufacturers have also appeared on the market, including some Equipment commonly used in homes and hospitals. For example, medical trauma treatment vehicles, etc.
Extended information
The medical device industry is a multi-disciplinary, knowledge-intensive, capital-intensive high-tech industry with high entry barriers. The overall level of medical equipment in Chinese medical institutions is still very low. Among the medical devices and equipment in primary medical and health institutions across the country, about 15% are products made around the 1970s.
There are 60 products produced before the mid-1980s. Their upgrading process is also a process of demand release, which will ensure the rapid growth of China's medical device market in the next 10 years or even longer. .
With the deepening of reform and opening up, the continuous increase of national support and the acceleration of global integration, China's medical device industry has developed by leaps and bounds. The "China Medical Device Industry Market Forecast and Investment Forecast Analysis Report" shows that in 2005, China has become the world's third largest medical device market after the United States and Japan.
In 2006, China's medical device import and export volume exceeded the 10 billion U.S. dollar mark for the first time. The total import and export value was 10.552 billion U.S. dollars, a year-on-year increase of 1.757 percent, and the cumulative surplus was 3.190 billion U.S. dollars. In 2007, China's total import and export of medical devices was US$12.697 billion, a year-on-year increase of 20.33%, and the annual trade surplus was US$4.133 billion.
Although there is a gap between China's medical device industry and developed countries, the speed of development of China's medical devices has attracted the attention of the world. China's latest research and development of medical device products are also at the forefront of the international medical device industry. In the next few years, China will surpass Japan and become the world's second largest medical equipment market.
By 2010, China's total output value of medical devices will reach 100 billion yuan, and its share of the world's medical device market will account for 5%. By 2050, this share will reach 25%.
With the rapid improvement of R&D capabilities of domestic enterprises and the shift of market focus from high-tech to popularization, the competitiveness of domestic products is gradually increasing, providing rare opportunities for domestic manufacturers to expand the market. It is foreseeable that China's medical device industry will have huge room for development in the future.
Reference: Baidu Encyclopedia of Medical Devices