Decision No. 18/2005/QD-TTg On approving the Project "Research, Manufacturing and Production of Medical Equipment until 2010"

DECISION OF THE PRIME MINISTER

Regarding the approval of the Project "Research, Manufacturing and Production of Medical Equipment until 2010"

medical equipment by 2010"

______________________

PRIME MINISTER

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

Pursuant to the Prime Minister's Decision No. 130/2002/QĐ-TTg dated October 4, 2002 on approving the National Policy on Medical Equipment for the period 2002-2010;

Considering the proposal of the Minister of Health,

DECISION:

Article 1. Approve the Project "Research, Manufacturing and Production of Medical Equipment until 2010" with the main contents as follows:

I. OBJECTIVES OF THE PROJECT

1. General objectives

Focus scientific and technological potential throughout the country to form and develop the domestic medical equipment manufacturing industry with the goal of being able to produce and supply essential and commonly used medical equipment, as well as some high-tech medical equipment for healthcare levels by 2010, ensuring the implementation of the objectives of the National Policy on Medical Equipment for the period 2002-2010.

2. Specific objectives

a) Ensure that by 2005, 40% and by 2010, 60% of the demand for essential and commonly used medical equipment in the entire healthcare sector can be met.

b) Intensify investment in production lines for medical equipment to improve quality, update designs, and introduce brands to meet domestic needs and gradually participate in regional and global export activities.

c) Form domestic scientific and technological bases capable of researching and manufacturing high-tech medical equipment including various types of X-ray, diagnostic ultrasound, electrocardiogram, high-frequency surgical scalpel, medical laser, biochemical analysis equipment, hematological equipment...

d) Expand and complete the system for calibrating medical equipment to ensure by 2010, it has the capability to calibrate all types of medical equipment subject to periodic calibration according to the regulations of the Ministry of Science and Technology.

đ) Develop human resources specialized in medical equipment; establish and consolidate a nationwide system of maintenance and repair centers for medical equipment, initially focusing on representative facilities in Hanoi, Da Nang, Ho Chi Minh City, and gradually expanding to provinces and cities to tap potential and enhance internal capacity to successfully implement the main contents of the National Policy on Medical Equipment for the period 2002-2010.

e) Utilize effectively the medical equipment already equipped at facilities throughout the healthcare sector.

II. CONTENTS, IMPLEMENTATION SCHEDULE AND COMPONENT PROJECTS

1. Principles and criteria for research, manufacturing, and production of medical equipment

To successfully implement the National Policy on Medical Equipment for the period 2002-2010, investment in research, manufacturing, and production of medical equipment must ensure scientific, economic, and effective principles and criteria as follows:

a) Principles:

- Products domestically produced, of good quality, and accepted by users should continue to improve quality, perfect, and update designs, striving to meet domestic demand, reduce imports, and eventually achieve exports.

- For medical equipment that Vietnam can affirm it can manufacture, the Ministry of Health needs to closely coordinate with relevant ministries and sectors to accelerate research, trial production, and promptly propose necessary supportive policies.

- For medical equipment that Vietnam cannot yet produce and will have to import over the next 10 to 15 years, correct types must be imported to meet professional requirements and technical levels specified by the Ministry of Health. At the same time, actively or through joint ventures and collaborations with domestic and foreign partners, research models and production processes to select suitable types, aiming to design and trial-manufacture such medical equipment independently.

b) Criteria for selecting types of medical equipment to focus on research, manufacturing, and production:

- They must be essential medical equipment serving primary health care at grassroots healthcare levels, meeting common requirements, widely applicable in hospitals and healthcare facilities, and aligning with the objectives of the National Policy on Medical Equipment for the period 2002-2010.

- They must be medical equipment with domestic usage experience, manufacturing potential, and produced by domestic facilities; they must be licensed for circulation by the Ministry of Health to ensure competitiveness in terms of quality and price compared to imported products.

- Priority production during 2005-2006 includes products requiring simple technical maintenance and easy user acceptance, ensuring effectiveness in diagnosis and treatment, and establishing credibility for domestically manufactured medical equipment.

- Medical equipment with complex technical design and construction, large size and weight, and high import and transportation costs should be concentrated on research and manufacturing to proactively meet domestic needs and limit imports.

- Medical equipment that has been researched, manufactured, and clinically tested at major hospitals, and accepted by users will transfer technology to production facilities capable of receiving technology and meeting ISO quality management standards for production from now until 2010.

- Concentrate on researching and selecting specialized high-tech medical equipment for diagnosis and treatment.

2. Types of medical equipment to focus on research, manufacturing, and production and implementation schedule until 2010:

a) Phase I: 2005-2006:

- Mass-produce large quantities with high quality to ensure meeting 40% of the total demand, moving towards exporting commonly used and traditional medical equipment such as hospital interior equipment, small-capacity sterilization equipment, general supplies, and educational medical tools.

- Intensively research and manufacture, perfect technology, and improve accuracy, durability, and safety of electronic medical equipment to meet domestic market demands, replace imports, and move towards exports.

- Invest in researching and trial-producing high-tech medical equipment, initially focusing on the following types:

+ Diagnostic equipment for primary healthcare facilities (X-ray machines, ultrasound, electrocardiogram, fetal Doppler...).

+ Operating room equipment, anesthesia and resuscitation equipment (ventilators, anesthesia machines, personal oxygen generators, patient monitoring devices, surgical knives, operating tables...).

+ Medical laser equipment, high-tech treatment equipment, and physical therapy and rehabilitation equipment.

+ Laboratory equipment, diagnostic testing equipment for primary healthcare facilities (biological microscopes, biochemical analyzers, hematology analyzers... and particularly accompanying test materials and chemicals).

+ Stainless steel implant materials, composite materials..., materials for Dental - Maxillofacial specialty.

+ Large capacity sterilization equipment, wastewater and medical waste treatment equipment.

b) Phase II: 2007 - 2010.

- Continue to expand production and improve the quality of medical equipment types produced during Phase I.

- Focus on perfecting technological processes and bringing into production high-tech medical equipment that has been successfully researched and developed during 2005 - 2006.

- Ensure the supply of 60% of common medical equipment needs across the entire sector. Vigorously promote joint ventures and collaborations in producing high-tech medical equipment, gradually reducing imports.

- Expand and ensure the stability of the export market for medical equipment.

3. Implementation

The project will be implemented through component projects. Units involved in researching, manufacturing, and producing medical equipment shall be responsible for building and submitting these projects for approval according to current regulations. Focus on implementing the following component projects:

a) Research, development, and production of hospital interior equipment and general medical supplies.

b) Research, development, and production of biochemical and hematological analysis equipment, laboratory equipment, and specialized medical supplies.

c) Research, development, and production of medical laser equipment and high-tech treatment equipment.

d) Research, development, and production of physical therapy and rehabilitation equipment.

đ) Research, development, and production of ward equipment, thermal equipment, and sterilization equipment.

e) Research, development, and production of imaging diagnostic equipment (X-ray for district level, black and white ultrasound, fetal Doppler...).

f) Research, development, and production of medical equipment and pharmaceutical industry equipment.

III. IMPLEMENTATION MEASURES

1. Group of solutions regarding resources and policies

a) Strengthen investment in funding and material, technical, means, tools, research materials for activities such as researching, developing, producing medical equipment, standardizing, repairing, maintaining, and training human resources to implement the project; manage, allocate, and use effectively and economically the mobilized funds for the research and production program of medical equipment.

b) Consolidate and improve the system of training specialized technical personnel in medical equipment. Enhance the quality, expand the scale, and types of training for the team of researchers and technical workers in medical equipment.

c) Strengthen and diversify technical service work for medical equipment. Consolidate and build operational mechanisms for medical equipment technical service centers nationwide. Make medical equipment calibration work mandatory and regular.

d) Gradually perfect the legal framework for the field of medical equipment, with particular emphasis on establishing policies to encourage and provide incentives for scientists, scientific and technological institutions, enterprises, and investors from all economic sectors to participate in researching, developing, producing, exploiting, and using medical equipment.

2. Group of solutions for researching and trial-producing medical equipment in Vietnam

a) Develop a plan for researching and trial-producing certain types of medical equipment for the period 2005 - 2010.

b) Invest in infrastructure and human resources for research and production centers for medical equipment. Study technological processes, expand the range of medical equipment already manufactured, while improving quality and updating designs to suit the characteristics of the Vietnamese people and socio-economic conditions.

c) Strengthen cooperation between research agencies, investors, production units, and domestic healthcare facilities with technical experts in medical equipment during the research and development process.

d) Strengthen international cooperation in training cadres, research, and trial-production.

3. Group of solutions for mass production of domestically-made medical equipment

a) Invest in upgrading and modernizing production lines for medical equipment. Apply international ISO standards or equivalent for medical equipment production management. Ensure compliance with Vietnamese national standards (TCVN) or industry standards (TCN) for each type of medical equipment produced.

b) Strengthen technology transfer and technology introduction in the manufacture and production of medical equipment. Build product brands and ensure domestic reputation, aiming towards exports.

c) Strengthen joint ventures and cooperation with reputable medical equipment manufacturers in the region and worldwide for the production of medical equipment.

d) Encourage foreign-invested enterprises to invest in the production of medical equipment.

IV. IMPLEMENTATION FUNDS

The sources of implementation funds include:

1. State budget funds allocated to Projects and topics approved by competent authorities according to regulations and annual plans.

2. Science and technology research and development funds,

3. Production support funds, loans from the Development Support Fund,

4. Enterprise capital and other legitimate sources of funding,

5. Direct foreign investment.

Article 2.

- The Ministry of Health shall take the lead and coordinate with relevant ministries, sectors, and agencies to identify types of products with production needs and create conditions for medical equipment to be tested and clinically evaluated at major hospitals; direct the implementation of the project; guide, inspect, supervise, and compile the situation of its implementation; report annually to the Prime Minister; organize mid-term and final reviews of the implementation status in 2007 and 2010.

- The Ministry of Planning and Investment and the Ministry of Finance shall be responsible for budget allocation for implementation; provide guidance, inspect the implementation of the project's budget in accordance with the law; study and propose to the Government policies to support the development of domestically researched, manufactured, and produced medical equipment products.

- The Ministry of Science and Technology shall be responsible for reviewing, evaluating, and accepting scientific and technological research topics and pilot production projects at the national level concerning medical equipment products in accordance with regulations.

- The Ministry of Industry shall be responsible for directing and consolidating research units and manufacturing enterprises to cooperate with the Ministry of Health to form comprehensive resources in researching, manufacturing, and producing medical equipment.

Article 3. This Decision takes effect fifteen days from the date of publication in the Official Gazette.

Article 4. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of provincial People's Committees under central cities are responsible for implementing this Decision./.