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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:
08/2001/TT-BYT
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Hanoi, April 27, 2001
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CIRCULAR
GUIDING THE
EXPORT AND IMPORT OF MEDICAL EQUIPMENT SUBJECT TO SPECIALIZED MANAGEMENT FOR
THE 2001-2005 PERIOD
In furtherance of the Prime Ministers 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 2001-2005
period as follows:
I. UNITS LICENSED TO DEAL IN THE EXPORT
AND/OR IMPORT OF MEDICAL EQUIPMENT
1.1. Production and business enterprises of all
economic sectors, which are established or register their business according to
the provisions of Vietnamese laws, meet all conditions for production of and/or
trading in medical equipment and have already been granted codes of exporting
and/or importing enterprises by customs authorities shall be allowed to export
and/or import medical equipment.
1.2. Foreign-invested enterprises engaged in the
production of pharmaceutical products or medical equipment may export and
import medical equipment according to the provisions of the Law on Foreign Investment
in Vietnam and the provisions of this Circular.
II. A NUMBER OF PROVISIONS ON THE EXPORT AND
IMPORT OF MEDICAL EQUIPMENT
2.1. Entrusted export, import: The entrusted
export and/or import must comply with the regulations of the Trade Ministry in
Official Dispatch No. 3490/TM-XNK of July 23,1999.
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2.3. The medical equipment labels shall comply
with the Prime Ministers Decision No. 178/1999/QD-TTg and the Trade Ministrys
Circular No. 34/1999/TT-BTM of December 15, 1999.
III. PROCEDURES AND COMPETENCE TO GRANT
PERMITS FOR MEDICAL EQUIPMENT IMPORT AND/OR EXPORT
The applications for the import of medical
equipment subject to the specialized management (Appendix 1) shall be addressed
to the Health Ministry (the Medical Equipment and Project Department).
When submitting the applications, units shall
also have to submit the following documents:
3.1. Goods catalogue;
3.2. Circulation permits and quality certificates
(ISO, FDA, EC�) granted by competent bodies of the host countries (the
originals or notarized copies).
IV. TIME LIMITS FOR SETTLING DOSSIERS
10 days after the full receipt of valid dossiers
from enterprises, the Health Ministry shall make written replies and grant
import permits or clearly state the reasons in writing for the refusal thereof.
V. HANDLING OF VIOLATIONS
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5.2. The Inspectorates of the Health Services of
the provinces and centrally-run cities (called collectively the provinces)
shall according to their competence conduct the inspection and handling of
violations regarding the export and import of medical equipment in the
provinces under their respective management.
5.3. Enterprises engaged in the export and/or
import of medical equipment which violate the provisions of this Circular shall
be administratively sanctioned or examined for penal liability, depending on
the seriousness of their violations; if damage is caused, the compensation
therefor must be paid according to law provisions.
VI. IMPLEMENTATION PROVISIONS
6.1. This Circular takes effect 15 days after
its signing and replaces Circular No.13/2000/TT-BYT of May 29, 2000. The
previous regulations contrary to the provisions of this Circular shall all be
annulled.
6.2. The Medical Equipment and Project
Department and Inspectorate of the Health Ministry, the provincial Health
Services, Vietnam Medical Equipment Corporation, medical equipment- exporting
and/or - importing enterprises, foreign companies licensed to produce and/or
trade in medical equipment in Vietnam shall have to implement the provisions of
this Circular.
FOR THE MINISTER OF HEALTH
VICE MINISTER
Le Ngoc Trong
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(Promulgated together
with Circular No. 08/2001/TT-BYT of April 27, 2001)
I. IMAGE DIAGNOSIS EQUIPMENT:
1. CT Scanner
2. Magnet Rennance 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:
- Gastroscopy - Restoscopy - Recto-colonscopy
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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.
13. Narcotizers.
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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
22. Hematological testing apparatus
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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:
- Magnetictherapy - Electro-therapy -
Thermo-therapy.
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- Phototherapy.
VI. SPECIALIZED EQUIPMENT:
Obstetrics:
31. Infant incubators.
32. Pregnancy testing devices.
33. Fetuss heart monitor.
Cardiovascular: Specialized cardio- grafting and
culture equipment and materials:
34. Blood, serum transfusion tube set (+
needles).
Ophthalmology:
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36. Artificial crystalline lens
Faciomaxillodentology
37. Tooth and mouth surgery, dental materials
VII. EQUIPMENT OF OTHER KINDS:
38. Medical gas system.
39. Drug testing devices, contagious disease
detecting devices.
40. 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 at their demands without having to apply for
certification from the Health Ministry.-