Circular No. 08/2001/TT-BYT guiding the export and import of medical equipment under specialized management during the period from 2001 to 2005

CIRCULAR

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

under specialized management during the period from 2001 to 2005

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Implement Decision No. 46/2001/QĐ-TTg dated April 4, 2001 of the Government on the management of export and import of goods during the period from 2001 to 2005. The Ministry of Health guides the export and import of medical equipment under specialized management during the period from 2001 to 2005 as follows:

I. ENTITIES PERMITTED TO ENGAGE IN THE EXPORT AND IMPORT OF MEDICAL EQUIPMENT

1.1. Enterprises producing and trading in medical equipment established or registered for business in accordance with Vietnamese law, if they meet the conditions for production and trade in medical equipment and have been issued an enterprise code for export and import by customs, shall be permitted to export and import medical equipment.

1.2. Foreign-invested enterprises engaged in the production of pharmaceuticals or medical equipment may export and import medical equipment in accordance with the Law on Foreign Investment in Vietnam and the provisions of this Circular.

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

2.1. Export and import on consignment: Export and import on consignment must be carried out in accordance with Circular No. 3490/TM-XNK dated July 23, 1999 of the Ministry of Trade.

2.2. Orders for the export and import of medical equipment shall be prepared in three copies, one copy sent to customs, one copy sent to the enterprise, and one copy retained at the Ministry of Health (Department of Medical Equipment and Health Works). The copy sent to customs will be directly sent by the Ministry of Health to the General Department of Customs. On the order, there shall be stamps indicating "COPY FOR CUSTOMS," "COPY FOR ENTERPRISE," and the "COPY FOR ENTERPRISE" shall be used to present to the customs checkpoint upon receipt of goods.

2.3. The labeling of 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 AND AUTHORITY FOR GRANTING PERMISSION FOR THE EXPORT AND IMPORT OF MEDICAL EQUIPMENT

Orders for the import of medical equipment under specialized management (Annex 1) shall be submitted to the Ministry of Health (Department of Medical Equipment and Health Works).

When preparing orders, entities must submit the following documents:

3.1. Catalogues introducing the products;

3.2. Certificates of circulation and quality certificates (ISO, FDA, EC...) issued by competent authorities of the country of origin (original or certified copies).

IV. TIME LIMIT FOR HANDLING APPLICATIONS

Within ten days from the date when the enterprise submits complete and valid documents, the Ministry of Health will issue a written response and grant an import permit, or provide written reasons for non-resolution in cases where it does not resolve.

V. VIOLATION HANDLING

5.1. The Department of Medical Equipment and Health Works and the Inspectorate of the Ministry of Health organize and implement inspections, audits, and handling of violations within their authority throughout the country regarding the activities of exporting and importing medical equipment.

5.2. Provincial Health Inspectors of provinces and centrally governed cities (referred to collectively as provinces) shall carry out inspections, audits, and handling of violations within their authority regarding the activities of exporting and importing medical equipment within the territory under their management.

5.3. Enterprises engaging in the export and import of medical equipment that violate the provisions of this Circular shall be subject to administrative penalties or criminal prosecution, depending on the severity of the violation, and shall be required to compensate for damages in accordance with the law if damage is caused.

VI. IMPLEMENTATION PROVISIONS

6.1. This Circular takes effect fifteen days from the date of issuance and replaces Circular No. 13/2000/TT-BYT dated May 29, 2000. All previous regulations contrary to the provisions of this Circular are abolished.

6.2. The Department of Medical Equipment and Health Works, the Inspectorate of the Ministry of Health, provincial health departments, the Vietnam Medical Equipment Corporation, enterprises engaged in the export and import of medical equipment, and foreign companies with permits to operate in the production and trade of medical equipment in Vietnam are responsible for implementing the provisions of this Circular./.