Circular No. 08/2001/TT-BYT dated April 27, 2001 of the Ministry of Health guiding the export and import of medical equipment subject to specialized management for the 2001-2005 period

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.

2.2. The medical equipment export and/or import application shall be made in 3 sets, of which 1 set shall be sent to the Customs, 1 set to the enterprise and 1 kept at the Health Ministry (the Medical Equipment and Project Department). The set sent to the Customs shall be forwarded by the Health Ministry directly to the General Department of Customs. Affixed on the goods import/export applications shall be the stamps "BO GUI HAI QUAN" (SET SENT TO CUSTOMS), "BO GUI DOANH NGHIEP" (SET SENT TO ENTERPRISE), and the "SET SENT TO ENTERPRISE" may be used for submission to border-gate customs upon the reception of goods.

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

5.1. The Medical Equipment and Project Department and the Inspectorate of the Health Ministry shall according to their competence organize and conduct the inspection and handling of violations throughout the country regarding the export and import of medical equipment.

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.

APPENDIX 1

(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

- 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 - Electro-therapy - Thermo-therapy.

- Microwave therapy - Hydro-therapy - Laser therapy.

- 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:

35. PHACO operating apparatus.

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.-