Decision 18/2005/QĐ-TTg

DECISION No. 18/2005/QD-TTg OF JANUARY 21, 2005 APPROVING THE SCHEME ON RESEARCH INTO MANUFACTURE AND PRODUCTION OF MEDICAL EQUIPMENT TILL 2010

THE PRIME MINISTER

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the Prime Minister’s Decision No. 130/2002/QD-TTg of October 4, 2002 approving the national policy on medical equipment for the 2002-2010 period;

At the proposal of the Minister of Health,

DECIDES:

Article 1.- To approve the Scheme on research into manufacture and production of medical equipment till 2010 with the following principal contents:

I. THE SCHEME’S OBJECTIVES

1. General objectives

To concentrate scientific and technological potentials nationwide on the formation and development of Vietnam’s medical equipment manufacturing industry, which, by 2010, will be capable of manufacturing and supplying essential and common medical equipment as well as a number of hi-tech medical equipment for medical establishments at all levels, ensuring the attainment of the targets of the national policy on medical equipment in the 2002-2010 period.

2. Specific objectives

a/ To satisfy 40% of the entire health service’s demand for essential and common medical equipment by 2005 and 60% by 2010.

b/ To make intensive investment in medical equipment production chains so as to raise the quality of equipment, improve their models and designs and introduce new brands, thus meeting the domestic demand and step by step involving in regional and world export activities.

c/ To set up domestic scientific-technological institutions with full conditions and capability for research into, and manufacture of, hi-tech medical equipment, including X-ray machines of all types, diagnostic ultrasonographs, electrocardiographs, high-frequency scalpels, medical lasers, biochemical and hematological analysators, etc.

d/ To expand and complete the medical equipment expertising system, which shall, by 2010, be capable of expertising assorted medical equipment subject to periodical expertise under regulations of the Ministry of Science and Technology.

e/ To develop a human resource specialized in medical equipment; to build and consolidate the national system of medical equipment maintenance and repair centers, first of all in Hanoi, Da Nang and Ho Chi Minh city, then in other cities and provinces, with a view to tapping potentials and bringing into play internal strengths, ensuring successful materialization of the principal contents of the national policy on medical equipment in the 2002-2010 period.

f/ To efficiently use medical equipment already furnished at the establishments of the entire health service.

II. IMPLEMENTATION CONTENTS AND ROADMAP AND COMPONENT PROJECTS

1. Principles and criteria for research into manufacture and production of medical equipment

To successfully implement the national policy on medical equipment in the 2002-2010 period, the research into manufacture and production of medical equipment must be scientific, economic and efficient, complying with the following principles and criteria:

a/ Principles:

- With regard to products which can be made at home with high quality and are accepted by consumers, it is necessary to further raise their quality, perfect and improve their models and designs, striving to adequately meet the domestic demand, gradually reducing imports and proceeding to export such products.

- With regard to medical equipment which Vietnam has the capability to manufacture, the Ministry of Health should coordinate closely with the concerned ministries and branches in speeding up the research and trial manufacture for early production thereof, and promptly proposing necessary support policies.

- With regard to medical equipment which cannot be made in the country yet and need to be imported in the next 10 to 15 years, it is necessary to import the right categories, meeting the specialized demands strictly according to the right technical levels as defined by the Health Ministry. At the same time, to take initiative or enter into joint-venture or association with domestic and foreign parties in researching into new models and designs as well as technological processes so as to select appropriate categories, then proceed to self-design and experimentally manufacture of such medical equipment.

b/ Criteria for selection of assorted medical equipment for concentrated research into manufacture and production thereof:

- They must be essential medical equipment in service of primary healthcare at the grassroots medical establishments, meeting the requirements of popularity and wide-ranging application at hospitals and medical establishments and achieving the targets of the national policy on medical equipment in the 2002-2010 period.

- They must be medical equipment which Vietnam has experience in the use thereof and potential for manufacture and production; be produced by domestic establishments and granted circulation permits by the Health Ministry in order to ensure the quality and price competitiveness as compared to the imports of the same kind.

- Medical equipment to be prioritized for production in the 2005-2006 period shall be products with simple technical maintenance and use requirements, easy to be accepted by consumers, thus ensuring the efficiency in medical examination and treatment and build up prestige for home-made medical equipment.

- Attention should be paid to research into manufacture of those medical equipment with not-too complicated designs and technical structures, large sizes, heavy weight and requiring too high import and transportation expenses so as to take initiative in meeting the domestic demands and reduce imports.

- Medical equipment which have already been researched into, manufactured and clinically tested at big hospitals and accepted by users shall be technologically transferred to production establishments capable of receiving the technologies and meeting ISO quality management standards for production from now to 2010.

- To concentrate investment on research and selection of hi-tech specialized medical equipment in service of diagnosis and therapy.

2. Assorted medical equipment subject to concentrated manufacture research and production and the implementation roadmap to 2010:

a/ Stage 1: 2005-2006:

- To concentrate on the mass production of high-quality common and traditional medical equipment with a view to satisfying 40% of the entire health service’s demand, proceeding to export such products as hospital interior equipment, low-capacity sterilizers, common supplies and medical instruments for school use.

- To concentrate on manufacture research, technology perfection and quality improvement in terms of precision, durability and safety of medical electronic equipment so as to satisfy the domestic market’s demands, substitute imports and proceed to export such equipment.

- To invest in research and trial manufacture of hi-tech medical equipment, first of all:

+ Diagnostic equipment in service of grassroots medical establishments (X-ray machines, ultrasonographs, electrocardiographs, fetus cardiac dopplers…)

+ Operation, anesthetization and resuscitation equipment (respirators, anesthetic apparatuses, personal oxygenic apparatuses, patient monitors, scalpels of all kinds, operating tables…)

+ Medical laser equipment, hi-tech therapeutic equipment, physiotherapeutic and rehabilitation equipment.

+ Laboratory equipment, analytic and testing equipment in service of grassroots medical establishments (biological microscopes, biochemical and hematological testing devices…, especially accompanying supplies and chemicals for tests).

+ Human body transplants made of stainless steel, composite materials…, materials used specifically for odontology-maxilla-face.

+ High-capacity sterilizers, equipment for treatment of medical wastewater and refuse.

b/ Stage II: 2007-2010:

- To further expand production and raise the quality of assorted medical equipment which have been made at home at stage I.

- To concentrate on the perfection of technological processes, produce medical equipment with high technological content, which have already been successfully researched into and manufactured in the 2005-2006 period.

- To ensure to satisfy 60% of the entire health service’s demand for common medical equipment. To boost joint venture and cooperation in the production of hi-tech medical equipment, gradually reduce imports.

- To expand and stabilize markets for export of medical equipment.

3. Implementation organization

This Scheme shall be implemented through component projects. Units participating in manufacture research and production of medical equipment shall have to elaborate and submit for approval the projects strictly according to current regulations. Investment shall be concentrated on the execution of the following component projects:

a/ Research into manufacture and production of hospital interior equipment and common medical supplies.

b/ Research into manufacture and production of biochemical and hematological analysators, laboratory equipment and specialized medical supplies.

c/ Research into manufacture and production of medical laser equipment and hi-tech therapeutic equipment.

d/ Research into manufacture and production of physiotherapeutic and rehabilitation equipment.

e/ Research into manufacture, production of room equipment, thermal equipment and sterilizing equipment.

f/ Research into manufacture and production of image diagnosis equipment (X-ray machines for district-level medical establishments, black and white ultrasonographs, fetus cardiac dopplers…).

g/ Research into manufacture and production of medical and pharmaceutical equipment.

III. IMPLEMENTATION SOLUTIONS

1. Group of resource and policy solutions

a/ To enhance funding and investment in material and technical bases, facilities, research instruments and documents for activities of manufacturing and producing medical equipment, expertizing, repairing and maintaining them and training human resources for the implementation of the Scheme; managing, distributing and efficiently and thriftily using funding sources mobilized for the program on research and production of medical equipment.

b/ To consolidate and improve the system of training human resources specialized in medical equipment techniques. To raise the quality, expand the scale and forms of training researchers and technical workers specialized in medical equipment.

c/ To enhance and diversify technical services related to medical equipment. To consolidate and build the operation mechanism for medical equipment technical service centers nationwide. To make medical equipment expertising a compulsory and regular activity.

d/ To step by step perfect the system of legal documents in the domain of medical equipment, attaching special importance to the elaboration of incentive and preferential policies toward scientists, scientific and technological institutions, enterprises and investors of all economic sectors involved in manufacture research, production, exploitation and use of medical equipment.

2. Group of solutions to research and trial production of medical equipment in Vietnam

a/ To work out a plan on research and trial production of a number of medical equipment in the 2005-2010 period.

b/ To concentrate investment on material bases and human resources for medical equipment research and manufacturing centers. To research into technological processes, increase the number of home-made medical equipment categories while raising their quality and renovating their models and designs to make them suit human characteristics and socio-economic conditions of Vietnam.

c/ To intensify cooperation between research institutions, investors, production establishments and medical equipment technical specialists as well as domestic medical examination and treatment establishments in the manufacture research process.

d/ To boost international cooperation in the domains of personnel training, research and trial production.

3. Group of solutions to mass production of medical equipment in the country.

a/ To invest in the upgrading and renovation of medical equipment production chains. To apply ISO standards or equivalent standards to management of medical equipment production. To ensure the attainment of Vietnam standards (TCVN) or branch standards (TCN) by each medical equipment product.

b/ To enhance technical and technological transfer in manufacture and production of medical equipment. To build up product brands, ensuring domestic prestige and proceeding to export such products.

c/ To enhance joint venture and cooperation with prestigious medical equipment manufacturers in the region and the world in the production of medical equipment.

d/ To encourage enterprises with 100% foreign capital to invest in the domain of production of medical equipment.

IV. FUNDING FOR IMPLEMENTATION

Funding sources for scheme implementation include:

1. State budget funding allocated to projects and subjects ratified by competent authorities according to regulations and annual plans.

2. Capital for scientific, technological as well as research and development subjects.

3. Capital for production support, capital borrowed from the Development Assistance Fund.

4. Capital of enterprises and capital mobilized from other lawful sources.

5. Foreign direct investment sources.

Article 2.-

- The Ministry of Health shall assume the prime responsibility for, and coordinate with the concerned ministries and branches in, determining demanded types of product for production and creating conditions for the clinical testing and assessment of such medical equipment at big hospitals; direct the implementation of the Scheme; guide, inspect, supervise and synthesize the situation on implementation of the Scheme and annually report it to the Prime Minister; organize the preliminary review and final review of the implementation by 2007 and 2010.

- The Ministry of Planning and Investment and the Ministry of Finance shall have to allocate budget for scheme implementation; guide and inspect the use of budget funding for the Scheme under law provisions; study and submit to the Government for promulgation policies on support for development of medical equipment which are researched into, manufactured and produced at home.

- The Ministry of Science and Technology shall have to approve, evaluate and test before acceptance scientific-technological subjects and State-run projects on the trial production of medical equipment according to regulations.

- The Ministry of Industry shall have to direct and rally research institutions and production enterprises in coordination with the Ministry of Health to create a combined strength for research, manufacture and production of medical equipment.

Article 3.- This Decision takes effect 15 days after its publication in the Official Gazette.

Article 4.- The ministers, the heads of the ministerial-level agencies, the heads of the Government-attached agencies and the presidents of the provincial/municipal People’s Committees shall have to implement this Decision.

For the Prime Minister
Deputy Prime Minister
PHAM GIA KHIEM