Free Trade Zone | 'Test Water' | Medical Device Release | Forced R&D | 'Blank Board'
Medical Network May 31 hearing Guangdong and Tianjin in their own free trade zone to allow medical device registration and production separation, help to speed up the development of medical device innovation products.
The medical device policy in the free trade zone is constantly being liberalized.
A few days ago, the State Council issued a plan to further deepen the reform of the Guangdong, Tianjin and Fujian Free Trade Zones. The 21st Century Business Herald reporter noted that in the programs of Guangdong and Tianjin, they all mentioned such a policy: Allowing free trade zone medical equipment Registered applicants entrust Guangdong/Tianjin medical device manufacturers to produce products.
Yan Liang, vice president of the Shanghai Medical Device Industry Association, told reporters of the 21st Century Business Herald that allowing both registered entities and production entities to cooperate in promoting product listing is a policy change in the approval process before medical device listing, which will help accelerate the innovation of medical device products. .
In early April, the State Council decided to suspend the implementation of Article 11 of the “Regulations on the Supervision and Management of Medical Devices” in the international medical tourism predecessor of Boao Music City, Hainan Province. Suspension of this provision will result in urgent clinical need for the medical institutions in the predecessor region. And in China, there is no medical device that has been approved for registration of the same type of product. The Hainan Provincial People’s Government implements the import approval and uses it in designated medical institutions.
In successive months, in the predecessor zone and in the free trade zone, related medical device policies have been continuously relaxed. What do these adjustments mean and what impact will they bring?
Accelerate Medical Device Innovation
China's medical device industry is regarded by the industry as a sunrise industry. According to the “China Medical Device Industry Development Report (2017)”, the total annual sales of the medical device industry in China is expected to exceed RMB 700 billion by 2020. The growth rate of China's medical device industry will continue to maintain an average annual growth of more than 10%.
However, according to the 21st Century Business Herald reporter, similar to the currently hotly debated 'China Core' problem, China's medical device industry has a low ratio of R&D investment and weak original innovation capability.
The “China Medical Device Industry Development Report (2017)” pointed out that the 2016 R&D input of the top 20 medical device companies in China accounted for an average of 4.51% of revenue. Compared with developed countries, China’s medical device industry’s R&D investment is seriously insufficient.
In Guangdong, after the policy adjustment in the Tianjin Free Trade Zone, medical device registration and production were allowed to separate. According to the “Medical Device Supervision and Management Regulations”, the state implements one, two, and three types of management of medical devices in accordance with the degree of risk. The previous policy provides that The second type, third type medical device manufacturing enterprise shall drug The supervisory and administrative department applies for a production license, and at the same time submits a registration certificate for the medical device produced by the applicant for the enterprise registration, that is, the registration shall be the same subject.
'Guangdong, the liberalization of the Tianjin Free Trade Zone policy is an expansion of the original pilot project in Shanghai and will help speed up the development of innovative products. Product structure technology R&D units are often short boards in manufacturing. Production, processing and manufacturing often require equipment and personnel. The resources for training, quality control, are often not available for R&D product units. After the policy is liberalized, companies can concentrate on R&D, entrust production to other companies, and market specialized resources are effectively combined. ' Yan Liang explained to reporters.
In fact, the Shanghai Free Trade Zone was the first person to “eat crabs.” In 2017, Shanghai was the first country in the country to initiate reforms in the reform of the system of medical device registrants. At present, Shanghai’s pilot has achieved results. According to Shanghai Food and Drug Information from the Surveillance Authority's public information, Medtronic’s newly approved surgical power system product registration certificate shows that the entrusted manufacturing company is Jabil Technology (Shanghai) Co., Ltd. This is the second successful medical device registrant system in Shanghai. Pilot products.
Today, Shanghai's experience is being extended to two major free trade areas in Guangdong and Tianjin. Yan Liang said that the previous registration policy is also a consideration in the historical stage of national supervision. It is clearly not adaptable. Currently, the single entity is registered and produced. The listing turns into a dual channel where a single entity is listed or two partners promote product launch. This is obviously a regulatory advancement and meets the needs of international and domestic market environments. Expanding the pilot shows that this trend is accelerating the demand for development.
Decentralized access to imported medical devices
In early April, the State Council decided to suspend the implementation of Article 11(2) of the “Regulations on the Supervision and Management of Medical Devices” in the international medical tourism predecessor of Hainan Boao Music City. The content of this provision is for the second and third categories of medical devices. .
Prior to this, an overseas manufacturing enterprise that exports Type II and Type III medical devices to China's territory should be represented by its representative office set up in China or designated corporate entity in China. proxy Person, submitting registration application materials to the State Council Food and Drug Administration and the competent authority of the country (region) where the applicant is registered permits medical instruments Listed sales documents.
The responsible person of Siemens Medical told the 21st Century Business Herald reporter that the specific time-consuming of this process depends on the product's risk category, complexity and enterprise The speed of feedback on the issue of compensation is about 4 months to a year and a half. The responsible person stated that the 'second and third type of medical device implements product registration management' regulations and regulations, and domestic imports. The requirements are the same. The difference is that if the imported medical device is registered on the CFDA, it must first obtain the certificate of the country of origin, which means that the same medical device will be listed in the country at least one year later than abroad.
After suspending the implementation of this provision, the medical equipment urgently needed by the medical institutions in the forerunner zone and the products that have not been registered in China for the same variety of products shall be approved by the People's Government of Hainan Province for use in designated medical institutions. Medical equipment quickly enters the country.
At the same time, the State Drug Administration and the People’s Government of Hainan Province together with relevant departments formulate specific management measures, standardize the conditions and procedures for approval, detail the use of related imported medical devices, monitor adverse events, and import ports, clarify the responsibilities of supervision, and ensure that The use of imported medical devices is safe to effectively safeguard the people's health and life safety.
'Half the second paragraph of Article 11 of the "Regulations on the Supervision and Management of Medical Devices" in Hainan's preemptive area, it is good to import advanced medical devices that have not yet obtained a CFDA registration certificate and use them in medical institutions in Hainan's predecessor zone.' reporter.
The responsible person stated that China is Siemens Medical's second-largest market in the world and one of the fastest-growing markets. With the aging of the population, the diversification of diseases, the deepening of people’s disease prevention and health management, and the public hospital With the implementation of reform and grading diagnosis and treatment, medical devices and medical consumables have great room for development in the Chinese market.