Medical devices are entering a "golden development period"! Local funding incentive policies are in full swing!

As one of the country's strategic emerging industries and an industry predicted to produce the next richest man in the world, biomedicine has always been a hot spot for development in various places. Throughout the country, various places have successively introduced relevant policies to attract and encourage the development of the biomedicine industry. For medical devices, as long as they pass the review of the drug regulatory department and are approved to obtain a medical device registration certificate, they can receive a local fiscal reward of hundreds of thousands to tens of millions of yuan.

Region: Shanghai

Policy: "Action Plan for Promoting High-Quality Development of Shanghai's Biomedicine Industry (2018-2020)"

Validity period: From November 3, 2018 to 2020

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 500

Class II medical devices: /

Specific measures: For medical devices (different models combined) that have obtained Class III medical device certificates and have been produced or sold in this city since 2018, financial support of up to 10% of the initial R&D investment and not exceeding 5 million yuan will be provided. For new drugs and high-end medical devices that have been registered and certified by the U.S. Food and Drug Administration (FDA) or the European Medicines and Health Care Administration (EDQM) since 2018, each product (different dosage forms of drugs and different models of medical devices are calculated together) will be given a maximum of 10% but no more than 10 million yuan in financial support based on the initial R&D registration investment.

Region: Guangzhou

Policy: "Notice on Issuing Several Provisions on Accelerating the Development of the Biopharmaceutical Industry in Guangzhou (Trial)"

Validity period: From March 27, 2018 to March 26, 2021

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 50

Class II medical devices: 20

Specific measures: For enterprises in this city that obtain the first registration certificate for Class II and Class III medical devices, a reward of 200,000 yuan and 500,000 yuan will be given for each first registration certificate of the product. Support the construction of important public service platform projects such as non-clinical safety evaluation institutions (GLP) for drugs, clinical trial institutions (GCP) for drugs (including medical devices), clinical research hospitals with special professional requirements, and pilot and production platforms for the biopharmaceutical industry. The subsidy amount shall not exceed 30% of the total project investment, and a single project shall not exceed 10 million yuan. For local GLP, GCP, contract research organizations (CRO), biopharmaceutical industry pilot platforms and other R&D service institutions that provide services to biopharmaceutical companies in this city that have no investment relationship with these R&D service institutions, rewards will be given at 5% of the annual contract amount and invoice basis, with a maximum of no more than 5 million yuan. For new drugs (including APIs, innovative excipients, etc.) that have obtained new drug certificates, as well as registered or filed traditional Chinese medicine granules, innovative medical devices and priority approval medical devices, projects that have been industrialized in this city will be given post-subsidy support at 30% of the total project investment, with a maximum of no more than 4 million yuan.

Region: Shenzhen

Policy: "Notice on the Implementation of the First Batch of Support Plans for Shenzhen's Biopharmaceutical Industry in 2019"

Validity period: 9:00 on March 22, 2019, to 18:00 on April 22, 2019

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 500

Class II medical devices: 300

Specific measures: For medical device products, 40% of the cost approved by the project review report will be provided for post-funding, with a maximum of 3 million yuan for Class II medical devices and 5 million yuan for Class III medical devices.

Region: Hangzhou

Policy: "Implementation Opinions on Promoting the Development of Hangzhou's Biopharmaceutical Industry (Hangzhou-Zhejiang Office Letter [2018] No. 66)"

Validity period: From June 20, 2018 to December 31, 2020

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 80

Class II medical devices: 50

Specific measures: Focus on supporting the construction of public service platforms for the industrial chain. Support the construction of important public service platforms such as non-clinical drug safety evaluation institutions (GLP), drug (including medical device) clinical trial institutions (GCP), clinical research hospitals with special professional requirements, biopharmaceutical industry pilot platforms, and data centers, and provide 30% of the total investment in each platform, up to a maximum of 10 million yuan.

Local GLP, GCP, biopharmaceutical R&D outsourcing (CRO), biopharmaceutical industry pilot platform and other R&D service institutions that provide services to our city's biopharmaceutical enterprises with no investment relationship will be awarded 5% of the actual annual contract amount, with a maximum of 5 million yuan per institution per year.

For the first time to obtain a national medical device registration certificate and industrialize in the city, each innovative Class II medical device will be awarded 500,000 yuan, and each Class III medical device will be awarded 800,000 yuan.

Medical institutions in Hangzhou that purchase the first (set) of medical equipment approved by the provincial and municipal departments will be awarded 50% of the purchase amount of a single device, with a maximum of 2 million yuan per medical institution.

Region: Ningbo

Policy: "Ningbo City Accelerates Several Policy Measures for the Development of Biopharmaceutical Industry"

Validity period: September 21, 2018

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 200

Class II medical devices: 50

Specific measures: Subsidies will be provided for medical device products that are registered for the first time and have independent intellectual property rights, including: a maximum subsidy of 500,000 yuan for a single Class II medical device and a maximum subsidy of 2 million yuan for a single Class III medical device.

Region: Nanchang

Policy: "Notice on Several Policy Measures to Support the Development of Biopharmaceutical Industry"

Validity period: From June 7, 2016 to December 31, 2020

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 50

Class II medical devices: 5

Specific measures: For pharmaceutical companies that obtain national new drug certificates (including medical device registration certificates) or production approvals for new varieties and realize industrialization in this city for the first time, the full amount of the product's first registration fee will be rewarded, and a one-time reward will be given at the same time. A reward of 500,000 yuan will be given to new drugs of Class 3-4 chemical drugs, Class 3-6 traditional Chinese medicines, and Class 7-12 biological products and new varieties of Class III medical devices. For new Class II medical device products that fill the gaps in our province, a one-time reward of 50,000 yuan will be given for their clinical trial costs; after the product is registered and industrialized in the city, the first registration fee of the medical device product will be fully reimbursed. A one-time reward of 200,000 yuan will be given to chemical raw materials and Class III medical devices that have newly passed the US FDA or EU CE registration. A one-time reward of 50,000 yuan will be given to companies that pass the US FDA and EU CE certification for the first time.

Region: Suzhou

Policy: "Guiding Opinions on Accelerating the Development of Suzhou's Biomedicine Industry Cluster"

Validity period: 2018-2025

Rewards available to enterprises (10,000 yuan):

Class III medical devices: /

Class II medical devices: /

Region: Suzhou High-tech Zone

Policy: "Guiding Opinions on Promoting the Development of the Medical Device Industry (Trial)"

Validity period: October 1, 2017

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 500

Class II medical devices: 300

Region: Suzhou Industrial Park

Policy: "Implementation Measures of Suzhou Industrial Park on Further Promoting the Development of Biopharmaceutical Industry"

Validity period: 3 years from May 2018

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 300

Class II medical devices: 150

Specific measures: Subsidy support will be provided for new drugs, innovative medical devices and priority approval of medical device industrialization projects that have obtained new drug certificates.

Formulate a list of talents in short supply in the biopharmaceutical industry, and provide a wider range of salary subsidies for talents with professional backgrounds such as chemistry, pharmacy, molecular biology, bioengineering, genetics, and medicine.

Medical institutions that have conducted more than 200 cases of Class II medical devices in the clinical trial approval catalog can directly apply for one municipal demonstration science and technology project, and give priority support in project review and establishment; medical personnel who have completed 60 or more cases of Class III medical devices in the clinical trial approval catalog can directly apply for two municipal applied basic research and development projects (not the same person in charge) without being restricted by the number of applications from their units, and give priority support in project review and establishment.

The "Suzhou New Drug and Medical Device Clinical Trial Public Service Platform" was established, and relying on this platform, subsidies were provided to relevant medical institutions in the Yangtze River Delta region that conduct clinical trials for new drug and medical device companies in our city. For services provided by drug clinical trial institutions and contract research organizations (CROs) to pharmaceutical companies in this city, subsidies will be provided at 5% of the annual contract performance amount, up to 500,000 yuan.

In addition, various districts in Suzhou have introduced supporting policies, such as the Suzhou High-tech Zone's "Guiding Opinions on Promoting the Development of the Medical Device Industry (Trial)" and the Suzhou Industrial Park's "Implementation Measures for Further Promoting the Development of the Biopharmaceutical Industry in Suzhou Industrial Park", which have increased support from the aspects of tax incentives, industrialization encouragement, and talent incentives, forming an industrial policy system that echoes each other, promotes in a coordinated manner, and ensures implementation.

Region: Chengdu

Policy: "Implementation Rules"

Validity period: From October 18, 2016 to July 11, 2019

Rewards that can be obtained by enterprises (10,000 yuan):

Class III medical devices: 200

Class II medical devices: 100

Region: Chengdu Hi-tech Zone

Policy: "Several Policies of Chengdu Hi-tech Zone on Building a Bio-industry Ecosystem (Industrial Functional Zone) to Promote the Development of the Bio-industry"

Validity period: 30 days after the date of release, valid for 2 years

Rewards that can be obtained by enterprises (10,000 yuan):

Class III medical devices: 3,000

Class II medical devices: 1000

Specific measures: Subsidy standards for Class III medical devices with independent intellectual property rights (including invention patents, software copyrights, etc.) that have obtained clinical approval and entered clinical trials: up to 2 million yuan per item.

Class III medical devices that are first created in China, such as gene sequencing, tumor detection and treatment, laser surgery, medical imaging, and implantable tissue materials, will be given a one-time reward of up to 2 million yuan; Class II medical devices that are first created in China will be given a one-time reward of up to 1 million yuan; Class III medical devices that are not first created in China will be given a one-time reward of up to 1 million yuan; Class II medical devices that are not first created in China will be given a one-time reward of up to 300,000 yuan.

In addition, Chengdu Hi-tech Zone issued the "Several Policies of Chengdu Hi-tech Zone on Building a Bio-industry Ecosystem (Industrial Functional Zone) to Promote the Development of the Bio-industry", which has unprecedentedly strong support for blockbuster and superior varieties, with a maximum support of 30 million yuan.

Region: Xi'an High-tech Zone

Policy: "Several Policies of Xi'an National Independent Innovation Demonstration Zone to Support the Development of Biomedicine Industry"

Validity period: November 6, 2018

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 200

Class II medical devices: 30

Specific measures: For enterprises that obtain Class II and Class III medical device registration certificates and production approvals and achieve industrialization in the high-tech zone, 300,000 yuan and 2 million yuan will be awarded respectively. For enterprises that have newly applied for Class II medical device production licenses and achieved industrialization in the high-tech zone, 100,000 yuan will be awarded. For third-party inspection and testing institutions certified by the competent industry department, a one-time reward of 300,000 yuan will be given.

Region: Shijiazhuang High-tech Zone

Policy: "Shijiazhuang High-tech Zone's Policy on Promoting the Development of Biomedicine Industry"

Validity period: August 23, 2017, valid for 3 years

Rewards available to enterprises (10,000 yuan):

Class III medical devices: 300

Class II medical devices: 50

Specific measures: For medical devices with independent intellectual property rights (including invention patents, software copyrights, etc.) that have obtained clinical approval for Class III medical devices and entered clinical trials, each will be given 2 million yuan in funding; for those that have obtained national Class III medical device certificates and have landed production and settlement in our district, 3 million yuan in support will be given to R&D enterprises. For those that have obtained Class II medical device certificates and have landed production and settlement in our district, 500,000 yuan in support will be given to R&D enterprises.