Circular 06/2002/tt-Byt: Guide To Exporting, Importing Medical Equipment Specialized Management In The Period 2002-2005

Original Language Title: Thông tư 06/2002/TT-BYT: Hướng dẫn xuất khẩu, nhập khẩu trang thiết bị y tế thuộc diện quản lý chuyên ngành thời kỳ 2002 - 2005

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Circular exports, imports of medical equipment management in the period of 2002-2005 implementation of decision No. 46/2001/QD-TTg on 04/04/2001 by 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 2002-2005, as follows: i. UNITS are ALLOWED to export, the IMPORTING medical EQUIPMENT 1. Vietnam businesses have production and business functions, are eligible for production, business and medical equipment have been the General Department of customs code-level import-export business, was allowed to export, the import of medical equipment.
2. Enterprises production, medical equipment business invested foreign import-export functions are allowed to export, the import of medical equipment.
3. The producers, pharmaceutical business have export and import function imported medical equipment and chemical for drug testing and production.
II. SOME PROVISIONS Of The EXPORT And Import Of Medical EQUIPMENT 1. Export, import of Trustees: the export and import authorization must be made according to the regulations of the Ministry of Commerce at no. 3486/TM-EXPORT on July 23, 1999.
2. 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 for PERMISSION to export, the IMPORTING medical EQUIPMENT enterprises when performing export and import of medical equipment by category management (Appendix 1) must file sent to the Ministry of health (Service equipment and medical works) include the following contents : 1. Application for a permit for export, import of medical equipment (annex No. 2 *), the number consists of 3 sets, in that 1 the sender Of customs Bureau, 1 set of business and send a saved the Health Ministry. The Ministry sent to Customs will be the Ministry of health SENT to CUSTOMS stamp and submit directly to the General Department of customs. The send business will be stamped the Health Ministry SENT the enterprise, the enterprise used this to record the Customs gate when the goods receipt.
2. A copy of valid business registration certificate by the Department of planning and investment, the central-level cities; Registration certificate of import and export enterprise code due to the Customs level (only the first filing when applying for export or import).
3. documentation manuals, technical documentation (the original) and Vietnamese translations.
4. license and quality certificates (ISO, FDA, EC) the competent authorities of the country of origin (certified copy).
IV. IMPORT MODEL And SPARE PARTS, COMPONENTS And PRODUCTION Of Medical EQUIPMENT 1. Import business equipment, spare parts, accessories to serve manufacturing, medical equipment Assembly or for clinical trials to be the Ministry of health allowed.
2. Imports of medical equipment with the purpose of doing samples, participate in exhibitions, fairs, temporary import appeared to be the Ministry of health license and must be recovered at the end of the exhibition, the fair.
3. Imports of medical equipment in Vietnam: a) for medical equipment in the category specified in annex No. 1 must have a full profile as specified in section III of this circular.
b) for these devices, medical instruments directly into the human body must be tested at least three medical facility in Vietnam (by the Ministry of Health appointed) before allowing imports.
V. IMPORT medical EQUIPMENT aid, USED The import business and the State Agency social organization when asking for permission to import medical equipment in the form of aid, gifts, business is done properly the provisions of decision No. 64/2001/QD-TTg dated April 16, 2001 of the Prime Minister has issued.
1. for the used equipment, the Agency received only agree if the party receiving funding have the text of the authorized agency to confirm the quality of the goods it is also 80% or more over the original and new just announced for the sponsoring party when shipping authority of Vietnam allow relaying.
2. Businesses and individuals want to import medical equipment used as gifts, to perform properly the provisions of decision No 2019/1997/QD-BVHTT on 01/12/1997 of the Ministry of science, technology and environment and the Ministry of health granted must be retrieved.
VI. EXPORT LICENSING JURISDICTION, Imported 1. Service equipment and health is responsible for reception, organization records appraisal and licenses the export and import of medical equipment.
2. After 15 days (working days) from the date the business filed enough valid profile, the Health Ministry will be writing the reply and export licenses, import or stating the reason in writing with the cases not resolved.
VII. HANDLING VIOLATIONS 1. Service equipment and medical works in collaboration with the Ministry of health and inspection service, the Department organized relevant test, inspection and handling violation according to the authority on the scope of the country of exportation, importation of medical equipment.
2. the Department of health, the central cities (called the) make check, inspection and handling of violations under the authority of the export operation, importing medical equipment on the territory of the province administered.
3. active enterprises export, import of 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.
VIII. ENFORCEMENT Of TERMS 1. This circular effect after 15 days from the date of signing and replacing circular No. 8/2001/TT-BYT on 27/04/2001. The previous provisions contrary to the provisions of this circular are repealed.
2. Service of the equipment and facilities for health, Ministry of health inspectors of the Department, medical device Corporation Vietnam, enterprises and individuals are allowed to export, the import of medical equipment, the relevant units responsible for the implementation of the provisions of this circular.
(*) Not in annex No. 2.