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HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
HUNAN LUGUInternational Medical Apparatus And Instruments Park
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1 Part 2 The Second Stage
Background and Characteristics
Potential Client
Contents Part 1 The First Stage
Construction Scheme
Construction and Investment Situation
Part 3 The Overall Construction ThoughtTo Establish a Sci-tech and Industrial Base for National Medical Apparatus Industry
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Industry Background
In 2011, the market size of domestic medical apparatus and instruments
has achieved 400 billion RMB, of which 70% rely on imports, especially
95% high-end and large-scale equipment rely on imports. So the new
domestic new medical apparatus and instruments market will be over 200
billion during the 12th Five-Year Plan period.
In recent 3 years, the domestic medical apparatus and instruments
industry has maintained over 23% growth per year, far beyond our national
GDP growth. At the same time, it has greatly exceeded the annual growth
of 7% of international medical apparatus and instruments industry .
Background and Characteristics
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Industry Background
Due to our late starts and poor starting point, the international market
share of domestic medical apparatus and instruments industry is only 2%,
and the domestic market share is less than 30%. Our main medical products
mainly focuses on the low and high-end medical equipment. Therefore,
most high-end and large-scale equipment rely on imports.
The small and scattered pattern of medical apparatus and instruments
industry is especially damaging for its industry development. In the future,
industry aggregation would become the core power for the medical
equipment development.
Background and Characteristics
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Policy Background
Background and Characteristics
(1). In 2011, the State Food and Drug Administration required all medical equipment enterprises to
enforce Good Manufacturing Practice (GMP)
GMP is a set of mandatory standards applicable to the industry, like
pharmaceutical, food etc. It requires enterprises to meet the national
sanitary quality requirements in accordance with relevant state laws and
regulations from raw materials, personnel, facilities and equipment, as well
as the process, packing and shipping, quality control etc. and form a set of
operational practices. The practices is to help enterprises improve business
sanitary conditions, thus to improve timely if any problems were found
during the production process.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Background and Characteristics
Briefly speaking, GMP requires the manufacturing enterprises to
have good production equipment, rational production methods, as
well as perfect quality management and strict detection system to
ensure that the quality of the final product ( including food safety and
hygiene) would conform to the regulations.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Policy Background
(2). The National 12th Five-Year plan has included the bioengineering and pharmaceutical industry in seven strategic emerging industries.
Medical apparatus and instruments is an important foundation of medical and health system construction. It is a foundation with high strategic character, strong industrial promotion and growth. Its strategic position has been paid attention to countries all over the world. It has become a pretty important symbol to measure the level of national science and technology progress and national economy modernization.
Background and Characteristics
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Medical apparatus and instruments is a typical high-tech industry, where advanced technology has been intensive applied, different
disciplines are intensive, technology is integrated fully etc. It is not only a particular reflection to the cutting edge of technology level and
technology integration application ability of a nation, but an important engine to drive and lead multidisciplinary technology development .
Background and Characteristics
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
(3) In December, 2011, Ministry of Science and
Technology published the “Special 12th Five-
Year Plan of Medical Apparatus and
Instruments”. The specialized plan proposes to
establish eight to ten medical apparatus and
instruments industry base of science and
technology in China.
Background and Characteristics
Policy Background
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Construction Situation
1.The park will be completed and put into
operation within a year.The park, occupying1250 mu of land (equal to 833,333 square
meters), a total construction area of 1600,000 square meters and with
a total investment of 4.2billion RMB, is constructed by 4 stages. The
first stage is started in June 2012, and covers a construction area of
110,000 square meters. 9 GMP standard factory buildings and 1
worker dormitory has been completed. At the same time, 40
enterprises and research institutions at home and abroad have been
introduced. The first stage of investment has finished already. In
May, 2013, the workshop has put into service and the company has
formally put into production.
Construction and Investment Situation
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
2. The First Boosting International Medical Apparatus and Instruments Park
Hunan Lu Gu International Medical Apparatus and Instruments Park is a place
dominated by Changsha National High-tech Industry Development Zone, promoted
by Hunan Food and Drug Administration and relevant department, as well as
constructed by Hunan Lu Gu International Medical Apparatus and Instruments
Park Co., Ltd. It is a modernized industrial park, where production, research and
development of the products, technology transfer, as well as technology incubator,
professional testing, trade show, and industry links etc. can be realized.
Construction and Investment Situation
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Hunan Lu Gu International Medical Apparatus and Instruments Park
gathered a set of medical apparatus and instruments enterprises at home and
abroad to research and develop, produce, operate, and forming industry clusters
through planning and constructing a multi medical apparatus and instruments
park, thus to construct a multi functional industrial platform, to innovate service
operation pattern, also strengthen enterprise hatching and booster an
development. The aim is to establish a national medical apparatus and
instruments industry base of science and technology with five core advantages,
namely, policy, team, hardware, overseas, services to promote the enterprises
development.
Construction and Investment Situation
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
The Number of Medical Apparatus and
Instruments Enterprises : 41
Provincial Enterprises: 35
Out-of-Province Enterprises: 5
American Enterprises: 1
The Number of Medical Apparatus and
Instruments Research Institutions: 2
Shanghai Advanced Research Institute, Chinese Academy
of Sciences
Hunan Family Planning Institute, Peripheral Blood Cell
Culture Laboratory
Investment Achievements
Construction and Investment Situation
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1. Policy Advantage
agree to introduce and recommend excellent enterprises in or out of
province to do pioneering work in the park.
exempt regular approval procedure, establish a green passage for
approval and examination; shorten 1/3 of the legal time limit to apply a
park entrance permission in principle.
exempt clinical testing when making a products registration in
accordance with relevant policies and regulations.
Five Core Advantages
A Recommendation
Two Exemptions
Three Simplifications
Save time, save effort
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
set up a medical apparatus and instruments testing center to offer
relevant testing service; simplify the frequency of permission
examination and supervision inspection.
set up an enterprise service center to undertake GMP authentication,
technology transfer, etc. and other professional services.
simplify park entrance procedures according to changed procedures
when out-of-province enterprises making a park application.
Five Core Advantages
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
2.Team Advantages
Beijing See with Hi-Tech Investment and Development Co.,Ltd(北京海凭高科 ) has three manufacturing enterprises, four
products selling enterprises, three real estate companies, one construction company, and a consulting company, a property
management company. We have a strong and professional team.
Manufacturing Companies:
Beijing Haiping Yi Bai Medical Apparatus and Instruments Co., Ltd.
Shandong Tian Ren Electronics Co., Ltd.
Changsha Haiping Medical Apparatus and Instruments Co., Ltd.
Five Core Advantages
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Products Selling Companies:
Beijing Haiping Century Medical Apparatus and Instruments Co., Ltd.
Beijing Haiping Advanced Medical Apparatus and Instruments Co., Ltd.
Hunan Lu Ding Medical Apparatus and Instruments Co., Ltd.
American Haiping International Trading Co., Ltd.
Five Core Advantages
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Main Members of the Team:
Song Guangzheng: president, CEO; 20 years experience in medical apparatus and instruments industry.
Li Juan: executive vice president; a senior professional real estate manager.
Dong Xiaofei: vice president and general manager of American Haiping International trading Co., Ltd.
Ren Dequan: policy advisor; the former deputy director of State Food and Drug Administration, the former
deputy director of State Administrative Bureau of Traditional Chinese Medicine .
Mi Xianqiang: sience and technology advisor, a researcher of Chinese Academy of Sciences, a professor and
the chief expert in Chinese medical apparatus and instruments.
Cheng Genhong: international advisor, tenured professor of University of California-Los Angeles, an expert
in Thousands People Plan of China.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
3 、 Hardware Advantages
All buildings are well-designed in accordance with GMP Standards strictly, including 9 workshop with 8 layers, one
worker dormitory with 9 layers. Each workshop covers 5,000-7,000 square meters, and each layer varies from 679 square
meters to 921 square meters. All buildings have independent property rights, and placed in hierarchical pattern. House can
be rent or sold.
Five Core Advantages
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
4. Overseas Advantages
We have established a professional company in Chicago.
Offices have been found in New York and Los Angles to have medical apparatus and instruments high-tech cooperation and
exchange, and to invite investment for American medical apparatus and instruments enterprises. Preliminary success have
been achieved at present.
In the second half of this year, our company will set up a professional investment company in Europe, with German as the
head to invite investment in Europe.
Five Core Advantages
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
5. Service Advantages
1.Registration Service 2.Technical Service
3. Standard Clinical Trial Service 4. Financial Service
5. Exhibition Service 6. Biding and Tendering Service
7. Information Service 8. Overseas Market Service
Five Core Advantages
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1. Registration Service
Enterprise Registration
GMP Certification Consulting, Production License Registration,
Registration Certificate Renewal, New Products Registration Service.
In order to promote enterprises' development in the park, Hunan Lu Gu International Medical Apparatus And Instruments Park has set up 8 multi functional professional service systems on the basis of offering first class hardware facilities. Specifically including: registration service, standard testing service, technical exchange service, financial service, as well as conference exhibition service, bidding and tendering service, information service and overseas market service etc.
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
2. Technical Exchange Service
We will strengthen the introduction of foreign medical apparatus and
instruments brand enterprises and accelerate the introduction and
promotion of the latest international technology through building the
bridge between Chinese and foreign medical apparatus and instruments
industry by monthly communication conference. At the same time, we
will push enterprises to export brand, technology and products through
the incubation and cultivation of national excellent enterprises.
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Main Services:
(1) introduce international enterprise
(2) promote international advanced technology exchange and
cooperation
(3) promote the park enterprises to establish overseas branches and
export products and technology
(4) undertake international academic conferences
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
3. Standard Clinical Testing Service
Main Services:
(1) organize and draft products criteria
(2) undertake factory inspection of medical apparatus and instruments
(3) undertake clinical testing of new products
(4) provide registration testing service of medical apparatus and instruments
(5) organize expert appraising meeting
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
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发展规划
4. Financial Services
guide the gathering of high quality financial services and form a financial service industry chain, thus to meet park enterprises’ financial demand and decrease financial cost of medium-sized and small enterprises.
park services center has set up a service alliance with bank, VC/PE, petty loan, guarantors, credit organization and other organizations
assist qualified enterprises to apply for government interest subsidy
guide credit cultivation of enterprises in the park and help them to improve financial skills
Bank Cooperation, Financing Lending
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1
发展规划
Establish a Green Channel for Enterprises to go Public
invite financial securities or relevant department to have a tutoring after getting into the park, and assist the park enterprises to apply for special listed subsidy fund
assist enterprises in the park to hang out New 3 Board, and solve the problem to raise fund by utilizing different capital market.
has built up a channel to market rapidly in American OTCBB Stock Market and Nasdaq Stock Market.
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
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5. Exhibition Services
Products Exhibition and Exhibition Hallto promote development of enterprises in the park by creating an international medical apparatus and
instruments exhibition hall and network platform to display products and attending international medical apparatus
and instruments exhibition as a group.
Main Services:organize international medical apparatus and instruments exhibition
to have a high-end products display and brand show
release new products
display products networks and multi media
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1
Medical and Health Conferenceestablish an international conference center with superior environment and multi function and auxiliary facilities, like
hotel, restaurant, entertainment, business center to satisfy enterprises’ demand to high stakes meeting
Main Services:to undertake industry summit and different academic conferences
to undertake relevant conferences hold by industry associations, special organizations and government
to provide conference facility for different enterprises meeting in the park
Eight Service Platforms
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
6. Bidding and Tendering Service
Eight Service Platforms
to set up a medical apparatus and instruments bidding and tendering center to provide medical apparatus and instruments bidding and tendering service for enterprises in the park
Main Services: publish medical apparatus and instruments bidding and
tendering
information
provide a great hall for medical apparatus and instruments
bidding and tendering activity
other professional medical apparatus and instruments bidding
and tendering activity
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
发展规划
7. Information Services
Eight Service Platforms
“ a periodical, a newspaper and two websites”
A Helpful Platform
www.happygk.com
Official Website of Hunan Lu Gu Medical Apparatus and Instruments Park
www.lgime.com
An English and Chinese Magazine--- Instruments Window
A mobile phone newspaper---Instruments Mobile Phone Newspaper
Official Website of Beijing See with Hi-Tech Investment and Development Co.,Ltd.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Clinical Testing Cloud Platform
This project opens electronized data management and clinical research cloud data platform by utilizing cutting edge
information technology, like functional unit, template configuration, data quality control, ( 无钥签名数据保全 ) , mass
storage system and data processing etc.. The aim is to realize the standardization of medical apparatus and instruments
clinical research, and service for those enterprises in the park. The project also provides a supporting platform to set up
mass clinical research data.
Eight Service Platforms
Contents:(1) a research about medical apparatus and instruments clinical standardization (includes the standardization of
clinical testing scheme, the standardization of CRF form, the standardization of terms and encoding, the
standardization of data organization after clinical research, and template of statistical approach)
(2) a electronic research about medical apparatus and instruments clinical testing (includes collection of electronized
data,中央随机化流程及监控 , management of clinical testing project.)
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Significance:
(1) For those applicants:
the data used to do research tend to be much more reliable. The money has correctly used. The data research is suitable to
the market of products and also the product marketing. And the method of data collection and form is acting on international
convention, which is beneficial to product promotion and transaction.
(2) For the SFDA supervisor:
They are able to bring time monitoring cases into scheduling and quality. So the source data validation ( SDV ) is able to undertake at any time to avoid hasty and inefficiency caused by current field observation.
(3) For the research doctor:
It can avoid inefficiency, mistakes, and additional work caused by filling complicated CRF paper in handwriting.
The first period plans to use molecule diagnosing products as a pilot point. It has won the support from SFD, Hunan Food and
Drug Administration, and Shenzhen Mindray Electronic Medical International Co., Ltd.. In this May, the researcher of Chinese
Academy of Sciences ,Mi Xianqiang, and vice president of Mindray will come to Changsha to confirm the cooperation.
Eight Service Platforms
(3) medical apparatus and instruments clinical testing of cloud integration service platform research
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1
8. Overseas Market Service
Eight Service Platforms
A professional company have been established in Chicago.
Offices have been found in New York and Los Angles to have medical apparatus and instruments high-tech cooperation and exchange, and to invite investment for American medical apparatus and instruments enterprises. Preliminary success have been achieved at present.
In the second half of this year, our company will set up a professional investment company in Europe, with German as the head to invite investment in Europe.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1 Part 2 The Second Stage
Potential Client
Contents
Construction Scheme
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Construction Scheme
The Second Construction Stage
The second-stage construction land of the park occupies 400mu(equals to 266,667 square meters), a total planned investment of 1.25
billion RMB and with overall floorage of 0.5 million square meters. The main construction includes building GMP standard
workshops of medical apparatus and instruments, international medical apparatus and instruments incubator and accelerator, national
medical apparatus and instruments engineering technical research center, complementary area of international medical apparatus and
instruments logistics distribution center, expert, staff life and business activity. After the project is completed, supporting facilities,
like GMP standard workshops, latest international technology, information, finance, and logistics etc, would be offered to the
registered enterprises. The construction phrase will last 4 years, from 2013 to 2016.
After the project is completed, over 150 enterprises at home and abroad would be attracted to register in the park. More than 10
billion RMB output value would be realized. Taxes per year would reach 1.2 billion RMB. What’s more, not less than 500 mid-
senior talents would be brought in and over 5000 jobs would be provided in manufacture, technical field, trading, as well as logistics
and service industry etc.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1
Potential Client
1. Client in Hunan Province
Entrance
There are 470 medical apparatus and instruments manufacturing enterprises and about 1200 marketing enterprises in Hunan Province. 50% of which gathered mainly in Changsha. Over 90% enterprises lack independent property rights manufacturing and marketing place. And most lease place does not conform to the state medical apparatus and instruments GMP request enforced in 2011, which would be a threat to the survival and development of enterprises. Therefore, most provincial enterprises are in badly need of buying GMP standard workshop. But there are only 94,000 square meters GMP standard workshop can be provided in the first stage of construction, namely, about 40 enterprises are allowed to enter into the park. It is still a long way to satisfy enterprises’ demand in the province. 70 enterprises is expected to enter into the park in the second stage.
Common construction
There are 6 influential enterprises in the province has required to have a common construction.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1
Potential Client
Out-of-province Client
In accordance with the situation in first stage and established investment channel, more than 20 enterprises are expected to enter into the park in the second stage.
The Hunan Chamber of Commerce in Guangdong Province has organized a group of medical apparatus and instruments manufacturing enterprises in Pearl River Delta to investigate in our park. They showed their intention of entering our park as a group.
After Shenzhen Food and Drug Administration has connected with Hunan Food and Drug Administration, about 30 coastal enterprises would moved into inland. Support in policy, location choosing ands so on are expected.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
1
Contents
Part 3 Overall Construction Thought
To Establish a Sci-tech and Industrial Base for National Medical Apparatus Industry
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
Overall Construction Thought
The whole park should be lead by Changsha High-tech Development Zone, promoted by provincial or municipal food and
drug administration, and operated by Beijing See with Hi-Tech Investment and Development Co.,Ltd.
The planning use land of High-tech Development Zone occupies 1200 mu (equals to 800,000 square meters). The land will
be provided in three stages on the principle of “ connect each area and control the size, supply construction land in
phrases”.
To establish a sci-tech and industrial base for national medical apparatus industry
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
An Official Reply of High-tech Development Zone to Support the Establishment of National Medical Apparatus and Instruments Industrial Base
In order to carry out and implement The National Plan of Medium and
Long Term Science and Technology Development (2006-2020) and Special
12th Five Plan of Medical Apparatus and Instruments proposed by science
and technology department, and promote the development of Hunan
medical apparatus and instruments industry, our district agree Beijing See
with Hi-Tech Investment and Development Co.,Ltd. to start the second
stage construction of Medical Apparatus and Instruments Park. We have
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
An Official Reply of High-tech Development Zone to Supporting the Establishment of National Medical Apparatus and Instruments Base
already put the principle of “connecting each area and controlling the size, supplying construction land in phrases” in practice in our bio-medical industry park. Land would be provided according to the project situation. The total planned construction area covers 1200 mu (equal to 800,000 square meters). It is estimates that the supply of land of the first stage in 2013 would be 400 mu to 500 mu (266,667 square meters to 333,3333 square meters). At the same time, our park would strongly support Haiping to establish the industry park as a sci-tech and industrial base for national medical apparatus industry.
HUNAN LUGUInternational Medical Apparatus And Instruments Park
中国·湖南·长沙·麓谷国际医疗器械产业园
湖南麓谷国际医疗器械产业园有限公司HU NAN LUGU Medical International Apparatus And Instruments Park
Project Address : No.229, Guyuan Road, High-tech Development Zone of Changsha Tel : 0731——88337689Company Address : www.happygk.com Official Website of Hunan Lu Gu Medical Apparatus and Instruments Park www.lgime.com
Integration Operators of Medical Apparatus and Instruments Industry
Official Website of Beijing See with Hi-Tech Investment and Development Co.,Ltd.