The Development and Reform Commission of Shenzhen Municipality issued three policy measures including the Several Measures of Shenzhen Municipality for Promoting the High-Quality Development of High-end Medical Device Industry Clusters (hereinafter referred to as the “Measures”) on July 26, 2022, aiming to accelerate fostering high-end medical device industry clusters and enhance industry core competitiveness.
The Measures focus on supporting:
Instruments and equipment related to high-end medical imaging, in vitro diagnosis, life monitoring and life support, high-end implantation and intervention, emergency treatment, tumor radiotherapy, medical laparoscope, genetic testing, optical equipment, DNA synthesizers, intelligent rehabilitation aids, health management, etc.;
Various reagents and products required for disease screening and precision medication analysis;
High-end implantation and intervention products such as stent valves, ventricular assist devices, intraocular lenses, and orthopedic devices;
Biomedical materials such as biodegradable materials, induced regeneration and repair materials of tissues and organs, new dental materials, and high-value domestic substitute consumables; and
Application of surgical robots, intelligent software, and other artificial intelligence information technology in medical equipment scenarios.
The Measures propose to:
Support the construction of state-level innovation carriers such as state key laboratories and national engineering research centers in Shenzhen, with funding of up to RMB 30 million; support the construction of national enterprise technology centers in Shenzhen, with funding of up to RMB 15 million; Accelerate the construction of key medical device platforms at the municipal level and plan the layout of contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), inspection, measurement, and testing platforms, medical device review and approval public service platforms, laboratory test and pilot test platforms, and other major industrial service platforms at the municipal level, which will be funded according to 40% of the total project investment, up to RMB 50 million;
Fully fund high-level basic research and technology breakthroughs in frontier fields including new materials, new mechanisms, and new principles with up to RMB 30 million; fund, by stages, enterprises with technology breakthroughs and major industrialization projects that tackle problems that hinder the country’s development (including those focusing on the development of high-end imaging systems, surgical robots, new in vitro diagnostic equipment, high-end implantation and intervention products, high-performance medical chips, high-throughput gene sequencing instruments, and other major equipment, key components, and key raw materials), major equipment that is first mass-produced in China, or key components or raw materials successfully applied to medical device products, according to 40% of the total project investment, up to RMB 300 million;
Fund enterprises that newly construct or renovate medical device GMP plants and receive approval for medical device production licenses according to 40% of the actual construction or renovation cost, up to RMB 3,000/m2 and RMB 10 million in total, to meet the industrialization needs of enterprises;
Fund enterprises that receive medical device product registration certificates and achieve industrialization in the city or medical device producing enterprises in this city that undertake production (without investment or affiliation relations between entrusting and entrusted parties) pursuant to the medical device registrant and filing entity system according to 20% of the actual investment, up to RMB 15 million for a single variety and RMB 30 million for a single enterprise per year; and
Encourage enterprises to actively participate in the national centralized volume-based procurement of medical devices to expand the market, with funding for varieties selected therein according to 3% of the total procurement amount of the year, up to RMB 3 million for a single variety and RMB 5 million for a single enterprise per year.
The Measures shall come into force from the date of issuance and shall be valid for five years.
The Measures focus on supporting:
Instruments and equipment related to high-end medical imaging, in vitro diagnosis, life monitoring and life support, high-end implantation and intervention, emergency treatment, tumor radiotherapy, medical laparoscope, genetic testing, optical equipment, DNA synthesizers, intelligent rehabilitation aids, health management, etc.;
Various reagents and products required for disease screening and precision medication analysis;
High-end implantation and intervention products such as stent valves, ventricular assist devices, intraocular lenses, and orthopedic devices;
Biomedical materials such as biodegradable materials, induced regeneration and repair materials of tissues and organs, new dental materials, and high-value domestic substitute consumables; and
Application of surgical robots, intelligent software, and other artificial intelligence information technology in medical equipment scenarios.
The Measures propose to:
Support the construction of state-level innovation carriers such as state key laboratories and national engineering research centers in Shenzhen, with funding of up to RMB 30 million; support the construction of national enterprise technology centers in Shenzhen, with funding of up to RMB 15 million; Accelerate the construction of key medical device platforms at the municipal level and plan the layout of contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), inspection, measurement, and testing platforms, medical device review and approval public service platforms, laboratory test and pilot test platforms, and other major industrial service platforms at the municipal level, which will be funded according to 40% of the total project investment, up to RMB 50 million;
Fully fund high-level basic research and technology breakthroughs in frontier fields including new materials, new mechanisms, and new principles with up to RMB 30 million; fund, by stages, enterprises with technology breakthroughs and major industrialization projects that tackle problems that hinder the country’s development (including those focusing on the development of high-end imaging systems, surgical robots, new in vitro diagnostic equipment, high-end implantation and intervention products, high-performance medical chips, high-throughput gene sequencing instruments, and other major equipment, key components, and key raw materials), major equipment that is first mass-produced in China, or key components or raw materials successfully applied to medical device products, according to 40% of the total project investment, up to RMB 300 million;
Fund enterprises that newly construct or renovate medical device GMP plants and receive approval for medical device production licenses according to 40% of the actual construction or renovation cost, up to RMB 3,000/m2 and RMB 10 million in total, to meet the industrialization needs of enterprises;
Fund enterprises that receive medical device product registration certificates and achieve industrialization in the city or medical device producing enterprises in this city that undertake production (without investment or affiliation relations between entrusting and entrusted parties) pursuant to the medical device registrant and filing entity system according to 20% of the actual investment, up to RMB 15 million for a single variety and RMB 30 million for a single enterprise per year; and
Encourage enterprises to actively participate in the national centralized volume-based procurement of medical devices to expand the market, with funding for varieties selected therein according to 3% of the total procurement amount of the year, up to RMB 3 million for a single variety and RMB 5 million for a single enterprise per year.
The Measures shall come into force from the date of issuance and shall be valid for five years.
Source: Innomd.org