Circular No. 06/2002/TT-BYT guiding the export and import of medical equipment under specialized management during the period of 2002-2005

CIRCULAR

Guidelines for Exporting and Importing Medical Equipment under Specialized Industry Management during the Period 2002-2005

Implementing Decision No. 46/2001/QĐ-TTg dated April 4, 2001 of the Prime Minister on the management of export and import activities during the period 2001-2005, the Ministry of Health issues guidelines for exporting and importing medical equipment under specialized industry management during the period 2002-2005 as follows:

I. ENTITIES PERMITTED TO EXPORT AND IMPORT MEDICAL EQUIPMENT

1. Vietnamese enterprises with production and business functions, having the necessary conditions to produce and trade in medical equipment and already registered with the General Department of Customs for export and import enterprise codes shall be permitted to export and import medical equipment.

2. Enterprises producing and trading in medical equipment with foreign investment capital and export and import functions shall be permitted to export and import medical equipment.

3. Enterprises producing and trading in pharmaceuticals with export and import functions shall be permitted to import medical equipment and chemicals for pharmaceutical production and testing.

II. SOME REGULATIONS ON THE EXPORT AND IMPORT OF MEDICAL EQUIPMENT

1. Agency export and import: Agency export and import must be carried out in accordance with Circular No. 3490/TM-XNK dated July 23, 1999 of the Ministry of Trade.

2. Product labeling for medical equipment shall be implemented in accordance with Decision No. 178/1999/QĐ-TTg of the Prime Minister and Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade.

III. PROCEDURES FOR APPLYING FOR PERMISSION TO EXPORT AND IMPORT MEDICAL EQUIPMENT

When enterprises carry out the export and import of medical equipment according to the specialized management list (Annex 1), they must prepare a dossier to submit to the Ministry of Health (Department of Medical Equipment and Health Facilities) including the following contents:

1. Application for permission to export and import medical equipment (Annex 2*), consisting of three sets, of which one set is sent to the General Department of Customs, one set is sent to the enterprise, and one set is retained by the Ministry of Health. The set sent to customs will be stamped by the Ministry of Health with "SENT TO CUSTOMS" and directly sent to the General Department of Customs. The set sent to the enterprise will be stamped by the Ministry of Health with "SENT TO ENTERPRISE", and the enterprise may use this dossier to present to the customs office at the port of entry when receiving goods.

2. A valid copy of the Business Registration Certificate issued by the Provincial Department of Planning and Investment; Export and Import Enterprise Code Certificate issued by the customs authority (only submitted once when applying for export and import).

3. User manuals and technical documents (original) and Vietnamese translations.

4. Circulation permits and quality certificates (ISO, FDA, EC...) issued by authorized agencies of the manufacturing countries (certified copies).

IV. IMPORT OF SAMPLES AND PARTS FOR PRODUCTION OF MEDICAL EQUIPMENT

1. Enterprises importing spare parts and components for the production, assembly, or clinical trial of medical equipment must obtain permission from the Ministry of Health.

2. Import of medical equipment for sample purposes, participation in exhibitions, fairs, temporary importation for re-exportation must be approved by the Ministry of Health with a permit and must be re-exported upon completion of the exhibition or fair.

3. First-time import of medical equipment into Vietnam:

a) For medical equipment listed in Annex 1, complete documentation as stipulated in Section III of this Circular must be provided.

b) For medical devices that are directly inserted into the human body, they must undergo testing at least at three designated Vietnamese healthcare facilities before being allowed to be imported.

V. IMPORT OF DONATED AND USED MEDICAL EQUIPMENT

Enterprises and state organizations importing medical equipment in the form of aid, gifts, or commercial transactions must comply with the provisions of Decision No. 64/2001/QĐ-TTg dated April 16, 2001 of the Prime Minister.

1. For used equipment, the receiving agency will only agree to accept if the donor has a certificate from an authorized agency confirming that the quality of the goods is still at least 80% of their original condition, and can only notify the donor to ship the goods after obtaining permission from the competent authority in Vietnam.

2. Enterprises and individuals wishing to import used medical equipment as gifts must comply with the provisions of Decision No. 2019/1997/QĐ-BKHCNMT dated December 1, 1997 of the Ministry of Science, Technology, and Environment and must obtain approval from the Ministry of Health.

VI. AUTHORITY TO ISSUE EXPORT AND IMPORT PERMITS

1. The Department of Medical Equipment and Health Facilities is responsible for receiving applications, conducting reviews, and issuing Export and Import Permits for medical equipment.

2. Within fifteen working days from the date of submission of complete and valid documentation, the Ministry of Health will issue a written response and Export and Import Permit or provide a written explanation for cases not resolved.

VII. SANCTIONS FOR VIOLATIONS

1. The Department of Medical Equipment and Health Facilities will cooperate with the Ministry of Health Inspectorate and relevant departments and units to organize inspections, audits, and handle violations within their jurisdiction nationwide regarding the export and import of medical equipment.

2. Provincial Health Departments (referred to collectively as provinces) will conduct inspections, audits, and handle violations within their jurisdiction regarding the export and import of medical equipment within the province's territory.

3. Enterprises engaged in the export and import of medical equipment who violate the provisions of this Circular will be subject to administrative penalties or criminal prosecution depending on the severity of the violation, and must compensate for any damages caused in accordance with the law.

1. This Circular takes effect fifteen days after its issuance date and replaces Circular No. 08/2001/TT-BYT dated April 27, 2001. All previous regulations inconsistent with this Circular are hereby abolished.

VIII. IMPLEMENTATION PROVISIONS

2. The Department of Medical Equipment and Health Facilities, the Ministry of Health Inspectorate, provincial inspectorates, the Vietnam Medical Equipment Corporation, enterprises and individuals permitted to export and import medical equipment, and related units are responsible for implementing the provisions of this Circular./.

(*) Annex 2 is not to be printed.

(*) Do not print Appendix number 2.