Thông tư 03/2001/TT-BYT hướng dẫn kinh doanh trang thiết bị, dụng cụ y tế do Bộ Y tế ban hành

CIRCULAR

GUIDING THE TRADING IN MEDICAL EQUIPMENT AND INSTRUMENTS

Pursuant to the Government’s Decree No. 11/1999/ND-CP of March 3, 1999 on goods banned from circulation, commercial services banned from provision; goods and commercial services subject to business restriction or conditional business";
The Ministry of Health hereby guides the trading in medical equipment and instruments according to the provisions of Section 1 of List 3, issued together with the Government’s Decree No. 11/1999/ND-CP of March 3, 1999 as follows:

Chapter I

GENERAL PROVISIONS

Article 1.- Medical equipment and instruments include all technical instruments and equipment, special-use transport means and corrosive medical materials, which are used in service of disease prevention, examination and treatment in the health service.

Article 2.- The trading in medical equipment and instruments is a form of conditional business.

Article 3.- Establishments dealing in medical equipment and instruments may operate only when they meet all conditions prescribed in this Circular and may only trade in the medical equipment and instruments already licensed by the Ministry of Health for circulation.

Chapter II

CONDITIONS FOR TRADING IN, EQUIPMENT AND INSTRUMENTS

Article 4.- Conditions for trading in medical equipment and instruments, applicable to enterprises:

A. FOR SALE/PURCHASE ENTERPRISES:

1. On personnel

a) Those who assume the main technical responsibility must graduate from technical universities, or university of medicine or university of pharmacy, and have certificates of one or more training courses on medical equipment and instruments, granted by medical facilities and equipment training establishments, or equivalent certificates granted by foreign countries.

b) Having a contingent of engineers and technicians fully capable of guiding, installing, giving guaranty to and maintaining the medical equipment and instruments which the enterprises trade in.

c) The above-mentioned persons must be physically fit, are neither examined for penal liability nor serving prison terms or deprived by the court of the right to professional practice.

2. On technical and material foundation:

a) Having offices and warehouses suitable and qualified for good preservation of medical equipment and instruments.

b) Having enough technical instruments and equipment for the installation and warranty of medical equipment and instruments.

c) Having enough means for fire prevention and fight, as well as ensuring environmental safety and hygiene.

3. On goods:

Enterprises may trade in medical equipment and instruments already licensed by the Ministry of Health for circulation.

B. FOR PRODUCTION ENTERPRISES:

1. On personnel:

a) Those who assume the main technical responsibility must graduate from technical universities, university of medicine or university of pharmacy, have certificates of one or more training courses on medical equipment and instruments, granted by medical facility and equipment training establishments, or equivalent certificates granted by foreign countries.

b) Having a contingent of engineers and technicians fully capable of meeting the production requirements set for the commodities produced by the enterprises

c) The above-mentioned persons must be physically fit, are neither examined for penal liability nor serving prison terms or deprived by the court of the right to professional practices.

2. On technical and material foundation:

a) Having the production ground areas suitable to the requirements set for the commodities produced by the enterprises.

b) Having enough equipment for the production and inspection of products’ quality, compatible with the commodities produced by the enterprises

c) Having enough means for fire prevention and fight, as well as for labor safety, and ensuring environmental safety and hygiene.

3. On goods:

Enterprises’ products may be circulated on the market only after they are granted circulation permits by the Ministry of Health.

Article 5.- Condition for dealing in medical equipment and instruments, applicable to individual business households:

1. On personnel:

a) Those who assume the main technical responsibility must have the diplomas of graduation from one of the following schools: the Medio-technical Intermediate Vocational School, the Pharmaco-technical Intermediate Vocational School, or the Medical Equipment Technicians’ School. Those who have intermediate technical degrees of other majors must have certificates of one or more training courses on medical equipment and instruments, granted by medical equipment and instrument training establishments, or equivalent certificates granted by foreign countries.

b) Being physically fit and neither examined for penal liability nor serving prison terms or deprived by the court of the right to professional practices.

2. On technical and material foundation:

a) Having shops and warehouses suitable and qualified for goods preservation of medical equipment and instruments.

b) Having enough necessary technical instruments for the maintenance and repair of medical equipment, and instruments.

c) Having enough means for fire prevention and fight, as well as ensuring environmental safety and hygiene.

3. On goods:

Individual business households shall be entitled to trade in hospitals’ interior equipment, assorted corrosive medical instruments and supplies which have been granted circulation permits by the Ministry of Health.

Chapter III

COMPETENCE AND PROCEDURES FOR THE GRANTING OF CERTIFICATES OF QUALIFICATION FOR TRADING IN MEDICAL EQUIPMENT AND INSTRUMENTS

Article 6.- The competence to grant certificates of qualification for trading in medical equipment and instruments:

The provincial/municipal (hereafter called "provincial" for short) Health Services shall be the agencies to expertise and grant certificates of qualification for trading in medical equipment and instruments.

Article 7.- Dossiers of application for certificates of qualification for trading in medical equipment and instruments business, for enterprises:

1. The application for the granting of certificate of qualification for trading in medical equipment and instruments.

2. Business registration certificate (valid copy)

3. Files on persons assuming main technical responsibility of enterprises

4. Files on technical workers, who conduct installation and warranty activities.

5. Documents on organizational apparatus, warehouses, and technical facilities and equipment.

Article 8.- Dossiers of application for certificates of qualification for trading in medical equipment and instruments, for individuals and business households:

1. The application for certificate of qualification for trading in medical equipment and instruments.

2. Business registration certificate (valid copy)

3. Files on persons assuming main technical responsibility for medical equipment and instruments

4. Documents on warehouses and technical facilities and equipment.

Article 9.- Within 15 working days as from the date of receiving full and proper dossiers, based on the result of the expertise of business conditions prescribed in this Circular, the provincial Health Services shall grant certificates of qualification for trading in medical equipment and instruments; in case of refusal, the reasons therefor must be clearly stated in writing.

Article 10.- Enterprises that are granted certificates of qualification for trading in medical equipment and instruments shall have to pay a fee according to current law provisions on charges and fees

Chapter IV

EXAMINATION, INSPECTION AND HANDLING OF VIOLATIONS

Article 11.- Examination, inspection

1. The Department for Medical Equipment and Health Facilities shall coordinate with relevant Departments and inspectorate of the Health Ministry in examining and inspecting the observation of law provisions on medical equipment and instruments and the provisions of this Circular throughout the country.

2. The provincial Health Services shall examine and inspect the observation of law provisions on medical equipment and instruments, and the provisions of this Circular in their respective localities.

3. The examination and inspection shall be conducted regularly or irregularly.

4. Establishments trading in medical equipment and instruments shall have to observe and create favorable conditions for the examination and inspection at their establishments.

Article 12.- Handling of violations:

The heads of medical equipment and instrument trading establishments, who violate the provisions of this Circular and other relevant law provisions shall, depending on the nature and seriousness of their violations, be administratively sanctioned or examined for penal liability, if damage is caused, the compensation therefor must be made according to law provisions.

Chapter V

IMPLEMENTATION PROVISIONS

Article 13.- This Circular takes effect 15 days after its signing and replaces Circular No. 14/1998/TT-BYT of November 17, 1998 providing guidance on medical equipment and instruments trading activities by private establishments.

In the course of implementation, if meeting with difficulties or problems, units and localities should report them to the Ministry of Health (the Department for Medical Equipment and Health Facilities) for consideration and settlement.

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