TƯ VẤN THỦ TỤC

Reply:

  Pursuant to Circular 24/2011 / TT-BYT dated June 21, 2014 of the Ministry of Health:

 - In Article 2 stipulates: Medical equipment are all kinds of equipment, tools, supplies, chemicals, including necessary software, used separately or in coordination with each other to serve people in order to Purpose: Preventing, examining, diagnosing, treating, alleviating disease or compensating for injury; Examining, replacing, modifying and supporting surgery in the process of medical examination and treatment; Support or maintain life; Control conception; Disinfection in health (excluding chemicals, insecticidal and germicidal preparations for domestic and medical use); Specialized transportation for medical activities.

- Clause 3, Article 4 stipulates: Importers do not have to apply for import licenses for medical equipment not included in the list specified in Appendix 1 except for the cases specified in Clause 2, Article 4 This Circular, but still must ensure the provisions at Points b and c, Clause 1, Article 5 of this Circular.

- In Clause 3a, Article 5 stipulates: For medical equipment outside the list prescribed in Appendix 1, but that device applies new diagnostic and treatment methods and first imported into Vietnam: Outside conditions and dossiers of procedures for applying for import permits as prescribed in Clause 1, Article 5, medical equipment for import must have results of evaluation of clinical trials and be approved by the Science and Technology Council. The Ministry of Health appraises and allows it to be allowed to import.