Bản dịch văn bản 06/2002/TT-BYT
thong-tu-06-2002-tt-byt
Cơ quan ban hành: Bộ Y tế
Ngày ban hành: 2002-05-30

CIRCULAR No CIRCULAR No. 06/2002/TT-BYT OF MAY 30, 2002 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 1. Entrusted export and import must comply with the Trade Ministry�s regulations in Official Dispatch No. 3490/TM-XNK of July 23, 1999. 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. 2. The import of medical equipment for use as model goods, for participation in exhibitions, fairs, or their temporary import for re-export, must be approved and granted permits by the Ministry of Health, and must be re-exported after exhibitions or fairs close. 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. 2. Within 15 (working) days, as from the date the enterprises submit full valid dossiers, the Ministry of Health shall reply them in writing and grant export or import permits, or clearly state the reasons in writing in case of refusal. 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. For the Minister of Health Vice Minister LE NGOC TRONG 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: - Gastroscopy - Restoscopy - Recto-colonscopy - 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. 13. Narcotizers. 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 22. Hematological testing apparatus 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: - Magnetictherapy - Microwave therapy - Phototherapy. - Electro-therapy - Hydro-therapy - Thermo-therapy. - Laser therapy. VI. Specialized equipment: Obstetrics: 31. Infant incubators. 32. Pregnancy testing devices. 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 VII. Equipment of other kinds: 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.