{"id":2289,"date":"2026-05-29T09:56:09","date_gmt":"2026-05-29T02:56:09","guid":{"rendered":"https:\/\/mednovum.com.vn\/?page_id=2289"},"modified":"2026-06-04T00:48:03","modified_gmt":"2026-06-03T17:48:03","slug":"ivd-medical-device","status":"publish","type":"page","link":"https:\/\/mednovum.com.vn\/en\/medical-device-classification-tool\/ivd-medical-device\/","title":{"rendered":"MEDICAL DEVICES (IVD)"},"content":{"rendered":"<div id=\"wpcontent\">\n<div id=\"wpbody\" role=\"main\">\n<div id=\"wpbody-content\">\n<div class=\"wrap\">\n<div class=\"card\">\n<div class=\"code-line\" data-line-number=\"1\" data-line-start=\"1\" data-line-end=\"1\">\n<div class=\"line-content\"><span class=\"mtk1\"><\/span><\/div>\n<\/div>\n<div class=\"code-line\" data-line-number=\"4\" data-line-start=\"4\" data-line-end=\"4\">\n<div class=\"line-content\"><\/div>\n<\/div>\n<div class=\"code-line\" data-line-number=\"5\" data-line-start=\"5\" data-line-end=\"5\">\n<div class=\"line-content\"><span class=\"mtk1\"><\/span><\/div>\n<\/div>\n<div class=\"code-line\" data-line-number=\"6\" data-line-start=\"6\" data-line-end=\"6\">\n<div class=\"line-content\"><span class=\"mtk1\">    <script>\n        window.mdrcData = {\"1\":{\"content\":\"Is the IVD medical device intended to detect the presence of, or exposure to, a transmissible agent in any of the following in order to assess their suitability for transfusion, transplant or cell administration?\\nBlood\\nBlood components\\nCells\\nTissues\\nOrgans or any of their derivatives\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>Examples: Tests to detect infection by HIV, HCV, HBV, HTLV. This rule applies to first-line assays, confirmatory assays and supplemental assays.<br>The risk classification above is based on Part III, Appendix 1 rule 1.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N\":{\"content\":\"Is the IVD medical device intended to detect the presence of, or the exposure to, a transmissible agent that causes a life-threatening, disease with a high or suspected high risk of propagation?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>Examples: Tests to detect infection by HIV, HCV, HBV, HTLV. This rule applies to first-line assays, confirmatory assays and supplemental assays.<br>The risk classification above is based on Part III, Appendix 1 rule 1.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N\":{\"content\":\"Is the IVD medical device intended for blood grouping or tissue typing to ensure the immunological compatibility of the following for transplantation, transfusion or cell administration?\\n\\nBlood\\nBlood components\\nCells\\nTissues\\nOrgans\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3Y\":{\"content\":\"Is it used to determine any of the following markers?\\n\\nABO systems [A (ABO1), B (ABO2), AB (ABO3)]\\nRhesus systems [RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e)]\\nKell system [Kel1 (K)]\\nKidd system [JK1 (Jka), JK2 (Jkb)]\\nDuffy system [FY1 (Fya), FY2 (Fyb)]\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3Y4Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3Y4N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3Y4Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 2.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3Y4N\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>Examples: HLA, Duffy systems other than FY1 (Fya) and FY2 (Fyb), which are Class D IVD medical devices.<br>The risk classification above is based on Part III, Appendix 1 rule 2.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N\":{\"content\":\"Is the IVD medical device intended to detect the presence of, or the exposure to, a sexually transmitted agent?\\n\\nExamples: sexually transmitted agents such as Chlamydia trachomatis, Neisseria gonorrhoeae.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N\":{\"content\":\"Is the IVD medical device intended to detect the presence of an infectious agent with a risk of limited propagation in cerebrospinal fluid or blood, an infectious agent with a risk of limited propagation?\\n\\nExamples: infectious agents such as Neisseria meningitidis or Cryptococcus neoformans.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N\":{\"content\":\"Is the IVD medical device intended to detect the presence of an infectious agent where there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested or to the individual`s offspring?\\n\\nExamples: diagnostic assay for Cytomegalovirus (CMV), Chlamydia pneumoniae, Methycillin Resistant Staphylococcus aureus\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N\":{\"content\":\"Is the IVD medical device intended for use in women\\u2019s pre-natal screening to determine their immunity towards transmissible agents?\\n\\nExamples: immune status tests for Rubella or Toxoplasmosis\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N\":{\"content\":\"Is the IVD medical device intended to determine the patient's infective disease or immune status where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation or severe disability for the patient or for the patient's offspring?\\n\\nExamples: IVD medical device to determine Enteroviruses, Cytomegalovirus (CMV) and Herpes Simplex Virus (HSV) viral load in transplant patients.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N\":{\"content\":\"Is the IVD medical device intended for use in screening for the following?\\n\\nPatient selection for selective therapy and management\\nDisease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring \\nCancer diagnosis (e.g. personalised medicine)\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N\":{\"content\":\"Is the IVD medical device intended for use in human genetic testing?\\n\\nExamples: devices for genetic testing in diseases such as Huntington's Disease or Cystic Fibrosis\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N\":{\"content\":\"Is the IVD medical device intended to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient or for the patient\\u2019s offspring?\\n\\nExamples: cardiac markers, cyclosporin, prothrombin time testing\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N\":{\"content\":\"Is the IVD medical device intended for use in the management of patients suffering from a life-threatening infectious disease or condition?\\n\\nExamples: IVD medical devices to determine the hepatitis C virus (HCV) or human immunodeficiency virus (HIV) viral load, or for HCV or HIV geno- and subtyping.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N\":{\"content\":\"Is the IVD medical device intended for use in screening for congenital disorders in foetus or embryo or intended for use in screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities?\\n\\nExamples: Devices to screen for congenital disorders such as Spina Bifida or Down Syndrome or G6PD\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N\":{\"content\":\"Is the IVD medical device intended for self-testing or for near-patient testing?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14Y\":{\"content\":\"Is the result produced by the IVD medical device either of the following?\\n\\nPreliminary, and requires follow-up with an appropriate laboratory test\\nNot used for determining a medically critical status\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14Y15Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14Y15N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14Y15Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 4.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14Y15N\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>Example: blood glucose monitoring.<br>The risk classification above is based on Part III, Appendix 1 rule 4.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N\":{\"content\":\"Is the IVD medical device intended for blood gases and blood glucose determinations?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15Y\":{\"content\":\"Is it for near-patient testing?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15Y16Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15Y16N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15Y16Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 4.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15Y16N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 4.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N\":{\"content\":\"Is the IVD medical device a product for general use in clinical laboratory, or accessories which possess no critical characteristics, intended by the product owner to make them suitable for IVD procedures related to a specific examination?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N\":{\"content\":\"Is the IVD medical device a standalone instrument (inclusive of software), intended by the Product Owner specifically to be used for IVD procedures, but not intended for use in specific medical diagnostic purposes?\\n\\nExamples: sample-preparation instruments.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N\":{\"content\":\"Is the IVD medical device a specimen receptacle?\\n\\nExample: plain urine cup\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N\":{\"content\":\"Is it a device, where an erroneous result will not cause death or severe disability and\\\/or present a low public health risk?\\n\\nExamples: blood gases, Helicobacter pylori (H. pylori) and physiological markers such as hormones, vitamins, enzymes, metabolic markers, specific immunoglobulin E (IgE) assays and celiac disease markers.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19N\":{\"content\":\"Is the IVD medical device a control without a quantitative or qualitative assigned value?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19N20Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19N20N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19N20Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part III, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N7N8N9N10N11N12N13N14N15N16N17N18N19N20N\":{\"content\":\"Sorry, we were unable to classify your device.\\nYou may wish to:\\n\\nReview your answers\\nCheck if your product is a medical device\\nRefer to our risk classification guide\",\"type\":\"question\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"}};\n    <\/script>\n    <div id=\"mdrc-app-container\"><\/div>\n    <\/span><\/div>\n<\/div>\n<div class=\"code-line\" data-line-number=\"7\" data-line-start=\"7\" data-line-end=\"7\">\n<div class=\"line-content\"><span 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