Chapter I General Provisions

Article 1 This policy is formulated for the purpose of further implementing the innovation-driven development strategy and promoting the high-quality development of medical device and biomedical industry in Suzhou New District.

Article 2 This policy applies to enterprises or organizations with independent legal personality that are engaged in the research and development, production and services related to medical device and biomedical industry.

Article 3 This policy focuses on encouraging the development of in vitro diagnostics, biomedical materials and implantation of interventional devices, medical imaging equipment, therapeutic equipment, rehabilitation medical equipment and other areas of high-end medical device products and key components, chemical and biological innovative drugs and related professional service organizations.

Chapter II encourages independent innovation

Article 4 of the enterprise research and development of medical equipment products to complete clinical trials, according to the actual expenditure on clinical trials to give subsidies, of which no more than 30% of the subsidies given to the second category of products, the third category of products to give subsidies of no more than 50% of the subsidies for a single enterprise subsidies per year up to a maximum of 5 million yuan.

Article 5 For the first class of innovative drugs and second class of improved new drugs carried out in China, according to the different phases of clinical trials, phase I, phase II and phase III, according to a certain percentage of the actual R & D investment will be given a maximum of 30 million yuan of support.

Article VI When an enterprise registers a medical device product, it will be given a 100% subsidy of the first registration fee, with a maximum subsidy of 500,000 yuan per year for a single enterprise.

Article VII of the medical device products into the national innovative medical device special review process, to give a maximum of 2 million yuan of financial support.

Article VIII For the first time to obtain a certificate of registration of medical devices and has independent intellectual property rights of the third class, the second class of medical device products, according to the actual research and development costs of a certain percentage of merit to give a maximum of 5 million yuan of support.

Article 9 For the first three generic drugs of the same kind in the country through the consistency evaluation of drugs, according to a certain percentage of the actual research and development costs to give a maximum of 5 million yuan of support.

Article X The establishment of medical-industrial cooperation and innovation research projects to support medical equipment and biomedical enterprises to strengthen cooperation with medical institutions, clinical needs, and jointly carry out medical equipment and biomedical field of clinical application of research and development and other scientific research activities, the project will be given a maximum of 200,000 yuan of support after the establishment of the project.

Chapter III accelerate the transformation of enterprise achievements

Article XI of the new U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Community (CE), Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved to obtain the qualification of overseas marketing of pharmaceuticals and medical devices, a maximum of 200,000 yuan of incentives for individual products.

Article XII The CXO platform that undertakes R&D and production services, and has no investment affiliation with the commissioning party, will be subsidized at the rate of up to 20% of the annual transaction fee, with a maximum of 5 million yuan per enterprise per year.

Article XIII encourages participation in the national centralized volume purchase of medicines. The winning varieties of a certain percentage of the total annual procurement of up to 2 million yuan reward.

Article XIV supports high-end medical devices and biomedical enterprises to enhance the scale of the first time included in the National Bureau of Statistics statistics network reporting platform of industrial enterprises above designated size (excluding turn-specialized enterprises), a one-time award of 100,000 yuan.

Article XV encourages the construction of medical device production sites. For new construction or renovation of medical equipment direction GMP plant and approved medical device production license enterprises, through the project record, according to the actual new construction or renovation costs of up to 40% of the maximum 2,000 yuan / square meter, to give a maximum of no more than 10 million yuan in funding.

Chapter IV Optimization of industrial innovation and entrepreneurship environment

Article XVI guide the establishment of medical device and biomedical industry fund, for the medical device and biomedical industry to be settled in Suzhou New District venture capital, private equity investment funds, to provide a fund size of up to 20% of the guidance fund, the contribution of a single major project of not more than 50 million yuan. The industry guidance fund prioritizes the introduction and support of medical devices and biomedical high-growth enterprises and key projects.

Article XVII of the purchase of medical devices and biomedical human clinical trials liability insurance and product liability insurance for enterprises or organizations, according to the actual payment of premiums for a single policy up to 50% of the maximum grant of up to 300,000 yuan.

Article 18 to build the medical device and biomedical industry ecosystem, encouraging industry associations, industry alliances and other social organizations or medical device and biomedical enterprises to organize technical docking, training lectures, high-end forums and other professional activities. For industry associations, industry alliances and other social organizations, according to the annual number of activities held, scale and other circumstances, to give the operating agency a certain amount of funding subsidies. For medical devices and biopharmaceutical enterprises to organize professional activities or participate in major exhibitions, to give the enterprise self-financing investment funds up to 20% of the funding subsidies, a single enterprise activities and exhibitors each year up to a maximum total subsidies of 200,000 yuan.

Article 19 encourages professional service organizations to provide medical device and biomedical enterprises with registration and declaration, regulatory consulting, research outsourcing, clinical evaluation and other related services, according to the previous year and the actual amount of medical device and biomedical enterprises to give the highest 20% of the actual service amount of incentives, the maximum award of 500,000 yuan per year for a single service organization.

Chapter V Supplementary Provisions

Article 20 The relevant content of this policy, if there is an overlap with other levels of support policies, from the higher but not repeated enjoyment.

Article 21 This policy is effective for three years from the date of publication. The original document "Suzhou New District on promoting the development of medical devices and biomedical industry implementation measures" (Suzhou High-tech tube [2020] No. 94) is abolished. 

Article 22 This policy shall be interpreted by the Administrative Committee of Suzhou New Hi-tech Zone, and the specific interpretation work shall be undertaken by the District Science and Innovation Bureau.