Circular additional amendments section IV and Appendix 3 of circular No. 08/2006/TT-BYT on 13/06/2006 of the Minister of health guide to import vaccines, medical products;
chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ To create favorable conditions and in accordance with the actual situation in the management of the State for importing medical equipment, the Ministry of health revised instructions, additional section IV. Regulations on imported medical equipment and Appendix 3 of circular No. 08/2006/TT-BYT on 13/06/2006 instructions to import vaccines, medical products; chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment (hereinafter referred to as the circular No. 08/2006/TT-BYT) as follows: 1. Amend paragraph headline Tuesday, point 1.2, paragraph 1 of section IV of the circular No. 08/2006/TT-BYT on record for imports of medical equipment in annex 7 is as follows : "document, the attached papers include: Catalogue (original); the manual documents, technical documents (accompanied by Vietnamese translations) of each type of equipment; Quality certificates (ISO, FDA, EC, ...) or equivalent; The license product circulation in the country of production (the original or a copy of valid)-(annex 9) ".
2. Amend paragraph 2, section IV of the circular No. 08/2006/TT-BYT on the import of equipment in addition to the list in annex 7 as follows: "2.1 traders want to import medical equipment in addition to the categories specified in Appendix 7 does not have to permit imports of the Ministry of health but must still ensure the provisions in points 1.1 and 1.2 clause 1 Section IV of the circular No. 08/2006/TT-BYT (the attached papers, documentation) ".
"2.2. medical equipment in addition to the above mentioned categories in annex 7 but the equipment that the application of the methods of diagnosis, new treatments and first imported to Vietnam must import permission of the Ministry of health. In addition to these conditions, record, import permit procedures as prescribed in clause 1, section IV of the circular No. 08/2006/TT-BYT, medical equipment import must have pleased the results of clinical trials and evaluation by the Council of science and technology of the Ministry of health, the evaluation allows the new imported ".
3. additional paragraph 3 on item IV of circular No. 08/2006/TT-BYT as follows: "for some special medical equipment have been international organizations accepted and recommended to use in the country, the Health Ministry would consider allowing long clinical trials based on the conclusions of the Council of science and technology of the Ministry of health".
4. Modify the section enclosed documents of application for imports of medical equipment in annex 9 of the circular No. 08/2006/TT-BYT as follows: "attached:-Catalogue (original) of each device type.
-use documentation, technical documentation (accompanied by Vietnamese translations) of each device type.
-quality certificate (ISO, FDA, EC, ...) or equivalent.
-permit circulation of the product in the country of production (the original or a copy of valid).
-must have a commitment to be responsible before the law for the quality, quantity and value of items please enter password ".
5. This circular takes effect after 15 days from the date The report.
Abolish headline Tuesday, point 1.2, paragraph 1 and Paragraph 2 of section IV and the documents attached to application for importing medical equipment in annex 9 of the circular No. 08/2006/TT-BYT of the Minister of health.