Circular No. 09/2006/TT-BYT guiding amendments and supplements to Section IV and Appendix 9 of Circular No. 08/2006/TT-BYT dated June 13, 2006, issued by the Minister of Health, guiding the importation of vaccines, medical products; chemicals, insecticides, and bactericides for household and medical use, and medical equipment.

CIRCULAR

Guidelines for amending and supplementing Section IV and Appendix 9 of Circular No. 08/2006

dated June 13, 2006, issued by the Minister of Health guiding the importation of vaccines, medical products;

chemicals, insecticides, bactericides used in household and medical fieldsand medical equipment

To facilitate and be appropriate with the actual situation in state management work on the importation of medical equipment, the Ministry of Health guides the amendment and supplementation of Section IV. Regulations on the importation of medical equipment and Appendix 9 of Circular No. 08/2006/TT-BYT dated June 13, 2006, guiding the importation of vaccines, medical products; chemicals, insecticides, bactericides used in household and medical fields and medical equipment (hereinafter referred to as Circular No. 08/2006/TT-BYT) as follows: 1. Amend paragraph 3, point 1.2, Clause 1, Section IV of Circular No. 08/2006/TT-BYT regarding the dossier for the importation of medical equipment listed in Appendix 7 as follows:

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"The accompanying documents include: Catalogue (original); user guide, technical documentation (with Vietnamese translation) of each type of equipment; Quality certificates (ISO, FDA, EC, etc.) or equivalent; Product registration certificate at the country of production (original or certified true copy) - (Appendix 9)."

 Amend Clause 2, Section IV of Circular No.

08/2006/TT-BYT regarding the importation of medical equipment outside the list specified in Appendix 7 as follows:

2. "2.1 Merchants wishing to import medical equipment outside the list prescribed in this Appendix 7 do not need to apply for an import permit from the Ministry of Health but must still comply with the provisions at point 1.1 and 1.2, Clause 1, Section IV of Circular No. 08/2006/TT-BYT (part of the accompanying documents)

"2.2 Medical equipment outside the list specified in Appendix 7, those equipment applying new diagnostic and treatment methods and being imported into Vietnam for the first time must apply for an import permit from the Ministry of Health. In addition to the conditions, dossiers, procedures for applying for an import permit as stipulated in Clause 1, Section IV of Circular No. 08/2006/TT-BYT, the medical equipment to be imported must have clinical trial results and be reviewed and approved by the Science and Technology Council of the Ministry of Health before being allowed to import." 3. Supplement Clause 3 into Section IV of Circular No. 08/2006/TT-BYT as follows:".

"For certain special medical equipment that has been accepted and recommended for use in other countries by international organizations, the Ministry of Health will consider granting permission to waive clinical trials based on the conclusion of the Science and Technology Council of the Ministry of Health."

4. Amend the accompanying documents of the application dossier for the importation of medical equipment at Appendix 9 of Circular No. 08/2006/TT-BYT as follows:

Attached:

- Catalogue (original) of each type of equipment.

"- User guide, technical documentation (with Vietnamese translation) of each type of equipment.

- Quality certificates (ISO, FDA, EC, etc.) or equivalent.

- Product registration certificate at the country of production (original or certified true copy).

- Must provide a commitment to bear legal responsibility for the quality, quantity, and value of the goods to be imported."

5. This circular takes effect 15 days after its publication in the Official Gazette.

Repeal paragraph 3, point 1.2, Clause 1 and Clause 2 of Section IV and the part of the accompanying documents of the application dossier for the importation of medical equipment at Appendix 9 of Circular No. 08/2006/TT-BYT of the Minister of Health./.

Tran Thi

Trung Chien