Circular 8/2001/tt-Byt: Guide To Exporting, Importing Medical Equipment Specialized Management In The Period Of 2001-2005

Original Language Title: Thông tư 08/2001/TT-BYT: Hướng dẫn xuất khẩu, nhập khẩu trang thiết bị y tế thuộc diện quản lý chuyên ngành thời kỳ 2001 - 2005

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Circular exports, imports of medical equipment management in the period of 2001-2005 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ made the decision No. 46/2001/QD-TTg dated 4/4/2001 of the Prime Minister on the management of the export and import of goods the period 2001-2005. The Health Ministry instructed the export and import of medical equipment management in the period of 2001-2005 are as follows: i. UNITS are ALLOWED to import EXPORT TRADING medical EQUIPMENT 1.1. Enterprises producing or trading in the economic sectors or business registry established under the provisions of the law of Vietnam, if eligible production, medical equipment business, has been granted the customs import and export enterprise code shall be allowed to export, the import of medical equipment.
1.2. The pharmaceutical manufacturing business or medical equipment of foreign-invested exporting, importing medical equipment under the provisions of the law on foreign investment in Vietnam and the provisions of this circular.
II. SOME PROVISIONS of the EXPORT and import of medical EQUIPMENT 2.1. Export, import authorization import-export: the trustee must follow the regulations of the Ministry of Commerce at no. 3486/TM-23/071999 IMPORT-EXPORT.
2.2. export orders, imports medical equipment was established as 3 sets, in that 1 the sending customs, 1 sent business and 1 accumulator at the Ministry of health (Service equipment and medical works). The Ministry sent to Customs will be sent directly to the Ministry of health General Directorate of customs. On the order stamped "Department SENDING CUSTOMS", "BUSINESS", and SENT to be used the "big business" to send the Customs gate when the goods receipt.
2.3. Tangle of medical equipment is made according to the decision No 178/1999/QD-TTg of the Prime Minister and circular No. 34/1999/TT-BTM on 15/12/1999 of the Ministry of Commerce.
III. procedure and ISSUED PERMITS to EXPORT, import medical EQUIPMENT orders of importing medical equipment in the specialized management (Appendix 1) was submitted to the Ministry of health (Service equipment and medical works).
When making the order, the unit must submit the following documents attached: 3.1. Catalogue introduction;
3.2. license and quality certificates (ISO, FDA, EC) the competent authorities of the country-level (original or certified copy).
IV. The TIME LIMIT for SETTLING the RECORD after 10 business days from the submission of a valid application, the Ministry of health will have text answers and import license, or stating the reason in writing with the cases not resolved.
V. 5.1 VIOLATION PROCESSING. Service equipment and medical works, Inspector of the Ministry of Health organized and conducted the inspection and handling of violations under the authority on the scope of the country of exportation, importation of medical equipment.
5.2. the Health Department Inspector, central cities (called the) make check inspection and handling of violations under the authority of the export activities, import medical equipment on the territory of the province administered.
5.3. Enterprises export activities, importing medical equipment in violation of the provisions of this circular, then depending on the level of violation would be sanctioning administrative violations or prejudice criminal responsibility, if the damage to compensation under the provisions of the law.
VI. ENFORCEMENT PROVISIONS 6.1. This circular effect after 15 days from the date of signing and replacing circular No. 13/2000/TT-BYT on 29/05/2000. The previous provisions contrary to the provisions of this circular are repealed.
6.2. the Service equipment and health, Ministry of health inspectors, provincial Department of health, medical device Corporation Vietnam, enterprises, import medical equipment, the foreign company has the license to operate the production, medical equipment business in Vietnam is responsible for enforcing the provisions of this circular.