On September 16, 2021, the Minister of Health promulgated Circular No. 13\/2021\/TT-BYT stipulating the issuance of circulation numbers and the import of medical equipment to serve the prevention and control of COVID-19 in case of urgent.<\/p>\n
Accordingly, medical equipment may apply the form of fast issuance of free registration numbers if the following conditions are satisfied at the same time:<\/strong><\/span><\/p>\n As medical equipment for the prevention and control of the COVID-19 epidemic, the circulation number is quickly issued on the list of regulations, including Extraction machine; PCR machine, Chemicals (biological products) running the PCR machine for testing SARS-CoV-2; Rapid test kit for antigen\/antibody against SARS-CoV-2; High-function ventilators, invasive and non-invasive ventilators, non-invasive ventilators, high-flow oxygen machines, portable ventilators; Continuous dialysis machine; Portable X-ray machine; Color Doppler ultrasound machine \u2265 3 probes; Blood gas meter (measuring electrolytes, lactate, hematocrit); Patient monitor \u2265 5 parameters; Electric injection pump; Infusion machine; Pacemaker defibrillators; ECG machine \u2265 6 channels; Portable ultrasound machine; Coagulation time meter; Hemodynamic meter.<\/em><\/p>\n Belongs to one of the following cases:<\/span><\/strong><\/p>\n 1. Has been approved for circulation or emergency use by one of the following organizations: US Food and Drug Administration (FDA) – USA; Therapeutic Goods Administration (TGA) – Australia; Health Canada (Health Canada); Japan’s Ministry of Health, Labor, and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) \u2013 Japan; This Circular takes effect from September 16, 2021.<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":" On September 16, 2021, the Minister of Health promulgat […]<\/p>\n","protected":false},"author":3,"featured_media":14701,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-14705","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-16"],"_links":{"self":[{"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/posts\/14705","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/comments?post=14705"}],"version-history":[{"count":0,"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/posts\/14705\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/media\/14701"}],"wp:attachment":[{"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/media?parent=14705"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/categories?post=14705"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bizlawyer.vn\/zh-hans\/wp-json\/wp\/v2\/tags?post=14705"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n2. Has been approved by the competent authorities of the European countries for circulation and emergency use;
\n3. Belongs to the list of SARS-CoV-2 testing products for emergency use announced by the World Health Organization (WHO) on its website at https:\/\/extranet.who.int (Coronavirus disease) (COVID-19) Pandemic – Emergency Use Listing Procedure (EUL) open for IVDs | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines, and Imm unification Devices, Vector Control);
\n4. Belongs to the list of popular products for testing for SARS-CoV-2 issued by the European Health Security Committee (EUHSC) published on its website at https:\/\/ ec.europa.eu (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu);
\n5. Having been granted a commercial import license in Vietnam before the effective date of this Circular (September 16, 2021);
\n6. Produced domestically in the form of technology transfer for medical equipment in one of the following cases (1), (2), (3), ( 4), (5) above;
\n7. Produced domestically in the form of processing for medical equipment in one of the following cases (1), (2), (3), (4), (5) above.<\/p>\n