Medical Device Definition and Classification

 

Medical devices refer to instruments, equipment, instruments, in vitro diagnostics and calibrators, materials and other similar or related items that are directly or indirectly used on the human body, including the required software, mainly for medical diagnosis, monitoring, and treatment; A wide variety of device products, according to the end customer and product characteristics, can be divided into home medical devices and medical equipment.

 

The medical device policy in the free trade zone is constantly being released

 

Recently, the State Council issued a plan to further deepen the reform and opening up of the Guangdong, Tianjin and Fujian Free Trade Zones. The programs in Guangdong and Tianjin mentioned such a policy: allowing medical device registration applicants in the pilot areas to entrust Guangdong/Tianjin medical device manufacturers to produce products, allowing both registered entities and production entities to promote cooperation. Listing of products is a policy change in the approval process of medical devices before they are listed, which helps to accelerate the innovation of medical device products.

 

Accelerate Medical Device Innovation

 

In recent years, with the economic development and the increase in the medical expenses of Chinese residents, the sales revenue of China's medical device industry has also maintained rapid growth. According to data released by the Industry Research Institute of the Forward-looking Industry Research Institute, the medical equipment industry's sales revenue increased from RMB 114.1 billion in 2010 to RMB 370 billion in 2016. The rate reached 21.67%. Compared with the growth rate of about 10% of the overall pharmaceutical market, the growth rate of the equipment is faster. It is expected that the medical device industry in China will maintain a rapid growth rate in the next three years. If the 20% growth rate is estimated, the overall scale of China's device market will exceed 760 billion by 2020.

 

However, similar to the currently hotly debated “China Core” problem, China’s medical device industry has a low proportion of R&D investment and weak original innovation capabilities. In 2016, the top 20 medical device companies in China accounted for an average of 4.51% of R&D expenditures as a proportion of operating income. Compared with developed countries, China’s medical device industry’s R&D investment is seriously insufficient.

 

After the policy adjustment in the Guangdong and Tianjin Free Trade Zones, the registration of medical devices and the separation of production are allowed. The state implements the first, second and third categories of medical devices in accordance with the degree of risk. The previous policy stipulated that the establishment of second- and third-class medical device manufacturing enterprises should apply for production licenses from the relevant food and drug supervision and administration departments, and submit registration certificates for the medical devices produced by the application companies, ie, registration and production. Be the same subject.

 

The liberalization of the policies in the Guangdong and Tianjin Free Trade Zones is an expansion of the original pilots in Shanghai and will help accelerate the development of innovative products. Product structure technology R&D units are often short boards in manufacturing. Production, processing, and manufacturing often require resources for equipment, personnel training, and quality control, which are often not available in R&D product units. After the policy is liberalized, companies can concentrate on R&D, entrust production to other companies, and effectively combine market-specific resources.