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THE
MINISTRY OF PUBLIC HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No:
06/2002/TT-BYT
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Hanoi,
May 30, 2002
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CIRCULAR
GUIDING
THE EXPORT AND IMPORT OF MEDICAL EQUIPMENT SUBJECT TO SPECIALIZED MANAGEMENT IN
THE 2002-2005 PERIOD
In furtherance of the Prime
Minister’s Decision No. 46/2001/QD-TTg of April 4, 2001 on the management of
goods export and import in the 2001-2005 period, the Ministry of Health hereby
guides the export and import of medical equipment subject to specialized
management in the 2002-2005 period as follows:
I. UNITS PERMITTED TO EXPORT
AND IMPORT MEDICAL EQUIPMENT
1. Vietnamese enterprises, which
have the production and business functions, full conditions to manufacture and
trade in medical equipment and export and import enterprise codes granted by
the General Department of Customs, shall be permitted to export and import
medical equipment.
2. Foreign-invested enterprises
which manufacture and/or trade in medical equipment and have the export and
import functions, shall be permitted to export and import medical equipment.
3. Enterprises manufacturing and
trading in pharmaceuticals and having the export and import function shall be
permitted to import medical equipment and chemicals in service of
pharmaceutical production and testing.
II. SOME PROVISIONS ON THE
EXPORT AND IMPORT OF MEDICAL EQUIPMENT
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2. Labels of medical equipment
shall comply with the Prime Minister’s Decision No. 178/1999/QD-TTg and the
Trade Ministry’s Circular No. 34/1999/TT-BTM of December 15, 1999.
III. PROCEDURES FOR
APPLICATION FOR PERMITS TO EXPORT AND IMPORT MEDICAL EQUIPMENT
In order to export and/or import
medical equipment on the list of those subject to specialized management
(Appendix 1), enterprises must compile dossiers and send them to the Ministry
of Health (the Department for Medical Equipment and Works), which consist of:
1. An application for export
and/or import of medical equipment (Appendix 2)(*), in three sets, of which one
shall be sent to the General Department of Customs, one to the enterprise, and
one to be archived at the Ministry of Health. The set to be sent to the Customs
shall be affixed by the Ministry of Health the stamp "SET SENT TO
CUSTOMS", and send it directly to the General Department of Customs. The
set to be sent to the enterprise shall be affixed by the Ministry of Health the
stamp "SET SENT TO ENTERPRISE." The enterprises may use this dossier
set for presentation to the border-gate customs offices upon receiving their
goods.
2. Valid copies of the business
registration certificate granted by the Planning and Investment Service of a
province or centrally-run city, the certificate of registration of the export
and import enterprise code, which is granted by the customs office (required only
for first-time application for export or import permits).
3. Original use instruction
documents and technical documents and their Vietnamese translations.
4. Circulation permits and
quality certificates (ISO, FDA, EC�.)
granted by competent authorities of the manufacturing countries (notarized
copies).
IV. IMPORT OF MODEL GOODS AND
COMPONENTS AND ACCESSORIES IN SERVICE OF THE MANUFACTURE OF MEDICAL EQUIPMENT
1. Enterprises must obtain the
permission of the Ministry of Health if they wish to import equipment,
components and accessories in service of the manufacture and/or assembly of
medical equipment or for clinical tests.
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3. First-time import of medical
equipment into Vietnam:
a/ For medical equipment on the
list prescribed in Appendix 1, they must be accompanied with full dossiers as
prescribed in Section III of this Circular.
b/ For medical equipment and
devices to be directly placed in human bodies, they must be tested in at least
three medical establishments in Vietnam (to be designated by the Ministry of
Health) before they can be permitted to be imported.
V. IMPORT OF DONATED OR USED
MEDICAL EQUIPMENT
Importing enterprises, State
agencies and social organizations, when applying for permits to import medical
equipment in forms of aid, gifts, or for business purposes, must strictly
comply with the provisions in the Prime Minister’s Decision No. 64/2001/QD-TTg
of April 16, 2001.
1. For used equipment, the
receiving agencies shall only agree to receive them if the donors have written
certifications of competent authorities that they still have 80% or over of
their original quality and shall ask the donors to deliver the goods only after
competent Vietnamese agencies permit them to receive such equipment.
2. If enterprises and
individuals wish to import used medical equipment in the form of gifts, they
must comply with the provisions in Decision No. 2019/1997/QD-BKHCNMT of
December 1, 1997 of the Ministry of Science, Technology and Environment, and
obtain approval and permission thereof from the Ministry of Health.
VI. COMPETENCE TO GRANT
EXPORT AND IMPORT PERMITS
1. The Department for Medical
Equipment and Works shall be responsible for receiving dossiers, organizing the
evaluation thereof and grant permits to export and/or import medical equipment.
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VII. HANDLING OF VIOLATIONS
1. The Department for Medical
Equipment and Works shall coordinate with the Inspectorate of the Ministry of
Health and the concerned departments in organizing the supervision, inspection
and handling of violations nationwide in the export and import of medical
equipment according to their competence.
2. The Health Services of the
provinces and centrally-run cities (referred to collectively as provinces)
shall supervise, inspect and handle violations in the export and import of
medical equipment in the provinces under their management according to their
respective competence.
3. If any enterprises engaged in
the export and/or import of medical equipment violate the provisions of this
Circular, they shall, depending on the seriousness of their violations, be
administratively sanctioned or examined for penal liability and, if causing any
damage, have to pay compensation therefor according to law provisions.
VII. IMPLEMENTATION
PROVISIONS
1. This Circular takes effect 15
days after its signing and replaces Circular No. 08/2001/TT-BYT of April 27,
2001. All previous regulations contrary to the provisions of this Circular
shall be hereby annulled.
2. The Department for Medical
Equipment and Works, the Inspectorate of the Ministry of Health, the provincial
Health Services, Vietnam Medical Equipment Corporation, enterprises and
individuals permitted to export and/or import medical equipment, and all
concerned units shall have to implement the provisions of this Circular.
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APPENDIX
1
(Issued together with Circular No. 06/2002/TT-BYT of May 30, 2002)
I. MEDICAL IMAGE DIAGNOSIS
EQUIPMENT:
1. CT Scanner
2. Magnet Resonance Imaging.
3. Fluoroscopy machines
4. Assorted X-ray machines for
image diagnosis and treatment
5. Doppler color, black and
white ultrasonic apparatus of various kinds:
6. Endoscopic equipment:
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- Abdoscopy - Ocularscopy
II. FUNCTION EXAMINATION
EQUIPMENT:
7. Basic specialization meter.
8. Electro-encephalograph (EEG)
9. Electro-retinograph.
10. Electro-cardiograph,
intensive electro-cardiograph, cardiac rate meter.
III. EMERGENCY INTENSIVE CARE
EQUIPMENT AND OPERATING THEATRE EQUIPMENT:
11. Cardiac fibrillation
breakers.
12. Respirators.
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14. Laser operating machines of
various kinds.
15. Electric operating knives.
16. Specialized surgery (heart,
brain�) equipment,
endoscopic surgery equipment.
17. Artificial heart and lung
apparatus.
18. Cardiac rate maker.
19. Patient monitor.
20. Ultrasonic operating knives,
laser operating knives.
IV. LABORATORY EQUIPMENT:
21. Biochemical testing
apparatus
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23. Immune testing apparatus.
V. Radio-therapeutic,
physio-therapeutic and functional rehabilitation equipment:
24. Linear accelerator.
25. Cobalt machine.
26. Low-intensity close
radio-therapeutic apparatus.
27. High-intensity close
radio-therapeutic apparatus.
28. Lithotrity apparatus.
29. Artificial kidney apparatus.
30. Physio-therapeutic
equipment:
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- Microwave therapy
- Phototherapy.
- Electro-therapy
- Hydro-therapy
- Thermo-therapy.
- Laser therapy.
VI. SPECIALIZED EQUIPMENT:
Obstetrics:
31. Infant incubators.
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33. Fetus’s heart monitor.
34. IUDs.
Cardiovascular:
Specialized cardio- grafting and culture equipment and materials:
35. Blood, serum transfusion
tube set (plus needles).
Ophthalmology:
36. PHACO operating apparatus.
37. Artificial crystalline lens
Faciomaxillodentology:
38. Tooth and mouth surgery,
dental materials
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39. Medical gas system.
40. Drug testing devices,
contagious disease detecting devices.
41. Brand-new ambulances.
Medical equipment outside the
above-mentioned list in Appendix 1 to this Circular may be exported, imported
by enterprises mentioned at Points 1 and 2 according to their demands without
having to apply for certification from the Health Ministry.-
(*) Not printed herein.
FOR THE MINISTER OF HEALTH
VICE MINISTER
Le Ngoc Trong