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Summary of medical device registration subsidies and related policies in many parts of China

2023/5/17 19:13:30¡¡Views£º370

In recent years, the State Council, the Development and Reform Commission and other departments have issued policies to support and regulate the biomedical industry. The medical device industry, as an important part of the biomedical industry chain, has also received extensive attention. 

 

Nowadays, many provinces/cities in China have issued corresponding policies to attract medical device enterprises to "settle" in their localities through policy subsidies, investment attraction and shortening the review time frame, so as to promote the high-quality development of the medical device industry.


Guangdong Province

The Action Plan for the Development of Strategic Pillar Industry Clusters of Biomedicine and Health in Guangdong Province (2021-2025) pointed out that the spatial layout of the dual-core, multi-node industry will be improved to create a biomedicine and health industry cluster. Create an industrial innovation cluster with Guangzhou and Shenzhen as the core and Zhuhai, Foshan, Huizhou, Dongguan and Zhongshan as the focus in Guangdong.

 

Guangxi Zhuang Autonomous Region

In 2021, Guangxi took biomedical industry as one of the 14 key industries for development and established a work mechanism of "a key industry, a special team for investment work, a leading department in the district, a set of investment program" to promote the biomedical industry investment and the development of biomedical industry at a high station, a high standard and a high intensity.

 

Hunan Province

The Opinions on Promoting the Innovative Development of Biomedical Industry states that it will support the R&D and innovation of drugs, medical devices and cosmetics, and give one-off subsidies by species to those who have obtained the approved document number and achieved production in Hunan.

 

Hubei Province

Wuhan¡¯s Policy Measures to Further Promote the Development of the Health and Biotechnology Industrystates that for products that have obtained registration certificates for Class II and Class III medical devices (excluding Class II diagnostic reagents and equipment parts), financial support will be given in accordance with 20% and 25% of the preliminary R&D expenses respectively, with a maximum financial support of RMB 2 million and RMB 10 million for a single product respectively.

 

Jiangsu Province

Several Policy Measures on Promoting the High-Quality Development of the Biomedical Industry in the Province states that funding support of RMB 10 million to RMB 30 million will be given on a merit basis to industrialization projects such as innovative drugs for which Phase II clinical studies have been completed and Phase III clinical trials have been initiated by independent legal entities registered in Jiangsu Province, and medical devices for which prototype (sample) testing has been completed (research has been initiated if clinical studies are required). 

 

Sichuan Province

Several Policy Measures on Supporting the High-Quality Development of Medical and Health Equipment Industry states that projects that have obtained the registration certificate of Class III medical devices (national innovative medical devices) and industrialized will be given an award of RMB 5 million. For projects that obtain the registration certificates of Class II and Class III medical devices (excluding diagnostic reagents, low-value consumables and national innovative medical devices) and industrialize them, or for projects in which domestic Class III medical devices are registered and listed in Europe and the United States, an award of up to RMB 2 million will be given.

 

Fujian Province

Implementation Plan for Accelerating the High-Quality Development of Biomedical Industry in Fujian Provincepoints out that for the three types of medical devices that enter the special review process of national innovative medical devices to obtain the product registration certificate and industrialize in Fujian Province for the first time, each variety will be given an award of RMB 2 million, and for the major projects among them, after evaluation, each variety will be given an award of up to RMB 6 million; the three types of medical devices that obtain the registration certificate and industrialize in enterprises that achieve industrialized production in Fujian Province for the first time, an award of 500,000 yuan will be given for each variety series, and the maximum amount of support for each unit will not exceed 5 million yuan per year.

 

Hainan Province

The Rules for the Implementation of the Management of Subsidy Funds for Supporting the Modern Biomedical Industry in Hainan Province to Grow and Strengthen states that enterprises are encouraged to carry out international certifications, and an award of RMB 2 million is given for each certification of pharmaceutical and medical device (Class II medical devices and above) manufacturers that have obtained international authoritative certifications.

 

Zhejiang Province

Hangzhou¡¯s Several Opinions on Accelerating the High-Quality Development of Hangzhou's Biomedical Industry (Draft for Comments) states that for medical device products entering the national special review process for innovative medical devices, each product will be given no more than 2.5 million yuan in funding support; for products entering the above process, obtaining a medical device registration certificate for the first time and being produced in Hangzhou, then no more than 40% of the R&D investment will be given, up to 6 million yuan Financial support; the cumulative amount of support for each unit shall not exceed RMB 15 million per year.

 

Beijing

The Implementation Guide of the 2022 Beijing High Precision Industry Development Fund states that incentives will be given to Class I and Class II drugs that have entered Phase II clinical trials and beyond since 1 October 2021, as well as AI/emergency approval medical devices that have entered the special/priority review process for innovative medical devices in the country and the city or have been approved for registration in the city, and are determined to be industrialized in the city.