{"id":2287,"date":"2026-05-29T09:55:35","date_gmt":"2026-05-29T02:55:35","guid":{"rendered":"https:\/\/mednovum.com.vn\/?page_id=2287"},"modified":"2026-06-04T00:49:45","modified_gmt":"2026-06-03T17:49:45","slug":"general-medical-devices","status":"publish","type":"page","link":"https:\/\/mednovum.com.vn\/en\/medical-device-classification-tool\/general-medical-devices\/","title":{"rendered":"GENERAL MEDICAL DEVICES"},"content":{"rendered":"<div id=\"input_line_0\"><\/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\":\"Does the device have an integral part which is a registrable medicine (therapeutic product) that only functions to act on the human body with action ancillary to that of the device?\\nExamples: bone cements with antibiotic, wound dressings incorporating antimicrobial agents to provide ancillary action on the wound\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1Y\":{\"content\":\"<h3>Your device is classified as Class D medical device with registrable therapeutic\\\/medicinal substances in secondary role.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 13.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N\":{\"content\":\"The device was manufactured from or has incorporated any of the following:\\n\\n(D)Derivatives of cells or tissues of human origin, rendered non-viable\\n\\n(C) Cells, tissues or their derivatives of animal origin (rendered non-viable) or recombinant origin\\n\\n(N) None of the above\",\"type\":\"question\",\"opt1_text\":\"Derivatives of cells or tissues of human origin, rendered non-viable\",\"opt1_target\":\"1N2D\",\"opt2_text\":\"Cells, tissues or their derivatives of animal origin (rendered non-viable) or recombinant origin\",\"opt2_target\":\"1N2C\",\"opt3_text\":\"None of the above\",\"opt3_target\":\"1N2N\"},\"1N2D\":{\"content\":\"Does the device incorporate non-viable tissues or derivatives that will come in contact with intact skin only?\\nExample: leather components of orthopaedic appliances.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2D3Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2D3N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2D3Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 14.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2D3N\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>Examples: porcine heart valves, catgut sutures<br>The risk classification above is based on Part II, Appendix 1 rule 14.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2C\":{\"content\":\"Does the device incorporate non-viable tissues or derivatives that will come in contact with intact skin only?\\n\\nExample: leather components of orthopaedic appliances.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2C3Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2D3N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2C3Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 14.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N\":{\"content\":\"What is the intended use of the device.\\n\\n(S) Sterilise or disinfect medical devices (including contact lenses), or hydrating contact lenses\\n\\n(C) Contraceptive or used to prevent the transmission of sexually transmitted diseases\\n\\n(N) None of the above\",\"type\":\"question\",\"opt1_text\":\"Sterilise or disinfect medical devices (including contact lenses), or hydrating contact lense\",\"opt1_target\":\"1N2N3S\",\"opt2_text\":\"Contraceptive or used to prevent the transmission of sexually transmitted diseases.\",\"opt2_target\":\"1N2N3C\",\"opt3_text\":\"None of the above\",\"opt3_target\":\"1N2N3N\"},\"1N2N3S\":{\"content\":\"Is the device intended specifically to disinfect, or hydrate contact lenses?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3S4Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3S4N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3S4Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 15.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3S4N\":{\"content\":\"Is the device intended to disinfect medical devices before end point sterilisation or before higher level disinfection?\\n\\nExample: washer disinfectors\\n\\nNote: This does not apply to products that are intended to clean medical devices by means of physical action, e.g. washing machines.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3S4N5Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3S4N5N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3S4N5Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 15.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3S4N5N\":{\"content\":\"<h3>Your device\\\\'s risk classification is Class C.<\\\/h3>\\r\\nExamples: devices for disinfecting or sterilising endoscopes, disinfectants intended to be used with medical devices.\\r\\nThe risk classification above is based on Part II, Appendix 1 rule 15.\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3C\":{\"content\":\"Is the device an implantable or invasive device for long-term use, i.e. continuous use of more than 30 days?\\n\\nExample: intrauterine contraceptive device\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3C4Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3C4N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3C4Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 16.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3C4N\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>Examples: condoms, contraceptive diaphragms.<br>The risk classification above is based on Part II, Appendix 1 rule 16.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N\":{\"content\":\"Is the device invasive?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y\":{\"content\":\"Does the device only penetrate the human body through a body orifice (non-surgically invasive)?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y\":{\"content\":\"Is the invasive device intended to be connected to an active medical device?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5Y6Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5Y6N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6Y\":{\"content\":\"Is the device intended to be connected to a Class B or Class C active medical device?\\n\\nExamples: tracheal tubes connected to a ventilator, suction catheters for stomach drainage, dental aspirator tips\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5Y6Y7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5Y6Y7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6Y7Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6Y7N\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N\":{\"content\":\"Describe the intended duration of continuous use of this non-surgically invasive device.\\n\\nTransient use i.e. less than 60 minutes\\nExamples: examination gloves, enema devices\\nShort term use i.e. between 60 minutes and 30 days\\nLong term use i.e. more than 30 days\",\"type\":\"question\",\"opt1_text\":\"Transient use\",\"opt1_target\":\"1N2N3N4Y5Y6N7T\",\"opt2_text\":\"Short term use\",\"opt2_target\":\"1N2N3N4Y5Y6N7S\",\"opt3_text\":\"Long term use\",\"opt3_target\":\"1N2N3N4Y5Y6N7L\"},\"1N2N3N4Y5Y6N7T\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N7S\":{\"content\":\"Is the invasive device intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the eardrum or in a nasal cavity?\\n\\nExamples: dentures intended to be removed by the patient, dressings for nose bleeds\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5Y6N7S8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5Y6N7S8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N7S8Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N7S8N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>Examples: urinary catheters, tracheal tubes.<br>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N7L\":{\"content\":\"Is the invasive device intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the eardrum, or in a nasal cavity and is not absorbed by the mucous membrane?\\n\\nExamples: orthodontic wire, fixed dental prothesis\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5Y6N7L8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5Y6N7L8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N7L8Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5Y6N7L8N\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>Example: urethral stent, contact lenses for long-term continuous use (for this device, removal of the lens for cleaning or maintenance is considered as part of the continuous use).<br>The risk classification above is based on Part II, Appendix 1 rule 5.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N\":{\"content\":\"What is the intended duration of continuous use for this surgically invasive device?\\n\\nTransient use i.e. less than 60 minutes\\nShort term use i.e. between 60 minutes and 30 days\\nLong term use i.e. more than 30 days\",\"type\":\"question\",\"opt1_text\":\"Transient use\",\"opt1_target\":\"1N2N3N4Y5N6T\",\"opt2_text\":\"Short term use\",\"opt2_target\":\"1N2N3N4Y5N6S\",\"opt3_text\":\"Long term use\",\"opt3_target\":\"1N2N3N4Y5N6L\"},\"1N2N3N4Y5N6T\":{\"content\":\"Is the device intended specifically for use in direct contact with the central nervous system?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6T7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6T7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N\":{\"content\":\"Is the device intended specifically to diagnose, monitor or correct a defect of the heart or the central circulatory system through direct contact with these body parts?\\n\\nExamples: angioplasty balloon catheters and related guide wires, dedicated disposable cardiovascular surgical instruments\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6T7N8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6T7N8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N\":{\"content\":\"Is the device intended to supply ionising radiation energy?\\n\\nExample: catheter incorporating or containing sealed radioisotopes\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6T7N8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6T7N8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N\":{\"content\":\"Is the device intended to have a biological effect, or be wholly or mainly absorbed?\\n\\nExample: insufflation gases for the abdominal cavity\\n\\nNote: The 'biological effect' referred to is an intended one rather than unintentional. The term 'absorbed' refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body. This does not apply to those substances that are excreted without modification from the body.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6T7N8N9N10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6T7N8N9N10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N10Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N10N\":{\"content\":\"Is this device intended for the administration of a drug via a delivery system where its mode of administration could be done in a potentially hazardous manner?\\n\\nExample: insulin pen for self- administration\\n\\nNote: The term 'administration of drug' includes storage or influencing the rate or volume of drug delivered and not just channelling. The term 'potentially hazardous manner' is in relations to the characteristics of the device and not the competence of the user.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6T7N8N9N10N11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6T7N8N9N10N11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N10N11Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N10N11N\":{\"content\":\"Is the device a reusable surgical instrument?\\n\\nExamples: manually operated surgical drill bits and saws\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6T7N8N9N10N11N12Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6T7N8N9N10N11N12N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N10N11N12Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6T7N8N9N10N11N12N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>A majority of such devices fall into several major groups: those that create a conduit through the skin (e.g. syringe needles, lancets), surgical instruments (e.g. single-use scalpels, surgical staplers, single-use aortic punch), surgical gloves, and various types of catheter\\\/sucker etc.<br>The risk classification above is based on Part II, Appendix 1 rule 6.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S\":{\"content\":\"Is the device intended to have a biological effect or to be wholly or mainly absorbed?\\n\\nExamples: absorbable suture, biological adhesive\\n\\nNote: The 'biological effect' referred to is an intended one rather than unintentional. The term 'absorbed' refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body. This does not apply to those substances that are excreted without modification from the body.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6S7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6S7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N\":{\"content\":\"Is the device intended specifically for use in direct contact with the central nervous system?\\n\\nExample: neurological catheter\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6S7N8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6S7N8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N\":{\"content\":\"Is the device intended specifically to diagnose, monitor or correct a defect of the heart or the central circulatory system through direct contact with these body parts?\\n\\nExamples: cardiovascular catheters, temporary pacemaker leads, carotid artery shunts\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6S7N8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6S7N8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N\":{\"content\":\"Is the device intended for the administration of medicines (therapeutic products)?\\n\\nNote: The term 'administration of medicines' includes storage and\\\/or influencing the rate or volume of medicine delivered and not just channelling.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6S7N8N9N10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6S7N8N9N10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N10Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N10N\":{\"content\":\"Is the device intended to undergo chemical change in the body (excludes devices that are placed in the teeth)?\\n\\nExample: surgical adhesive\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6S7N8N9N10N11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6S7N8N9N10N11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N10N11Y\":{\"content\":\"<h2><span style=\\\"font-size: 12pt\\\"><strong>Your device\\\\'s risk classification is Class C.<\\\/strong><\\\/span><\\\/h2>\\r\\nThe risk classification above is based on Part II, Appendix 1 rule 7.\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N10N11N\":{\"content\":\"Is the device intended to supply ionising radiation energy?\\n\\nExample: brachytherapy device\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6S7N8N9N10N11N12Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6S7N8N9N10N11N12N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N10N11N12Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6S7N8N9N10N11N12N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>Examples: infusion cannulae, temporary filling materials, non-absorbable skin closure devices, tissue stabilisers used in cardiac surgery (includes devices that are used during cardiac surgery but do not monitor or correct a defect)<br>The risk classification above is based on Part II, Appendix 1 rule 7.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L\":{\"content\":\"Is the device intended to be used in direct contact with the heart, the central circulatory system, or the central nervous system?\\n\\nExamples: prosthetic heart valves, spinal and vascular stents\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N\":{\"content\":\"Is the device intended to be life-supporting or life-sustaining?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N\":{\"content\":\"Is the device intended to be an active implantable medical device?\\n\\nExamples: pacemakers, their electrodes and leads, implantable defibrillators\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N\":{\"content\":\"Is the device intended to have a biological effect or to be wholly or mainly absorbed?\\n\\nExample: implants claimed to be bioactive\\n\\nNote: The 'biological effect' referred to is an intended one rather than unintentional. The term 'absorbed' refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body. This does not apply to those substances that are excreted without modification from the body.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8N9N10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N9N10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N\":{\"content\":\"Is the device intended for the administration of medicines (therapeutic products)?\\n\\nExample: rechargeable non-active drug delivery system\\n\\nNote: The term 'administration of drugs' includes storage and\\\/or influencing the rate or volume of medicine delivered and not just channelling.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8N9N10N11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N9N10N11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N\":{\"content\":\"the device intended to undergo chemical change in the body (excludes devices to be placed in teeth)?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8N9N10N11N12Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N9N10N11N12N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N12Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N12N\":{\"content\":\"Is the device a breast implant?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8N9N10N11N12N13Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N9N10N11N12N13N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N12N13Y\":{\"content\":\"<h3>Your device's risk classification is Class D.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N12N13N\":{\"content\":\"Is the device intended to be placed into the teeth?\\n\\nExamples: bridges, crowns, dental filling materials\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4Y5N6L7N8N9N10N11N12N13N14Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4Y5N6L7N8N9N10N11N12N13N14N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N12N13N14Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4Y5N6L7N8N9N10N11N12N13N14N\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>Examples: maxilla-facial implants, prosthetic joint replacements, bone cement, nonabsorbable internal sutures, posts to secure teeth to the mandibular bone (without a bioactive coating).<br>The risk classification above is based on Part II, Appendix 1 rule 8.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N\":{\"content\":\"Is the device an active medical device?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y\":{\"content\":\"Is the device an active therapeutic device intended to administer or exchange energy to or with the human body, or is a software?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6Y\":{\"content\":\"Considering the nature, density and site of application of the energy, could the administration or exchange of this energy be done in a potentially hazardous manner, including exposure to ionising radiation?\\n\\nExamples: lung ventilators, baby incubators, electrosurgical generators, external pacemakers and defibrillators, surgical lasers, lithotriptors, therapeutic xray and other sources of ionising radiation\\n\\nNote: The term 'potentially hazardous' is in relations to the type of technology involved and the intended application.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6Y7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6Y7Y\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6Y7Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 9i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6Y7N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>Examples: muscle stimulators, Transcutaneous Electro-Neuro Stimulator (TENS) devices, powered dental hand pieces, hearing aids, neonatal phototherapy equipment, ultrasound equipment for physiotherapy.<br>The risk classification above is based on Part II, Appendix 1 rule 9i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N\":{\"content\":\"Is the device non-invasive?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y\":{\"content\":\"Does the non-invasive device come into contact with injured skin?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y\":{\"content\":\"Is it intended to be used as a mechanical barrier, for compression or for absorption of exudates only, for wounds that heal by primary intention?\\n\\nExamples: compression bandages, cotton wool.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7Y8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7Y8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y8Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 1.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y8N\":{\"content\":\"Is it intended to be used to manage microenvironment of a wound?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7Y8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7Y8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y8N9Y\":{\"content\":\"Is it intended to be used principally with wounds that cannot heal by primary intention?\\n\\nExamples: dressings for chronic ulcerated wounds, dressings for severe burns\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7Y8N9Y10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7Y8N9Y10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y8N9Y10Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 1.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y8N9Y10N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>Examples: non-medicated impregnated gauze dressings.<br>The risk classification above is based on Part II, Appendix 1 rule 1.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7Y8N9N\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 1.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N\":{\"content\":\"Is the non-invasive device intended to modify the biological or chemical composition of blood, body liquids, or other liquids, for infusion into the body?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7N8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8Y\":{\"content\":\"Does the treatment consist of filtration, centrifuging or exchanges of gas or of heat?\\n\\nExamples: devices to remove carbon dioxide, particulate filters in an extracorporeal circulation system\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7N8Y9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N8Y9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8Y9Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8Y9N\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>Examples: haemodialysers, devices to remove white blood cells from whole blood.<br>The risk classification above is based on Part II, Appendix 1 rule 3.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N\":{\"content\":\"Is the non-invasive device intended for channelling or storing body liquids, tissues, liquids or gases for eventual infusion, administration or introduction into the body?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7N8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>Examples: urine collection bottles, compression hosiery, non-invasive electrodes, hospital beds.<br>The risk classification above is based on Part II, Appendix 1 rule 4.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9Y\":{\"content\":\"Is it a blood bag?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7N8N9N10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N8N9N10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N10Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 2i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N10N\":{\"content\":\"Can the non-invasive device to be connected to a Class B or Class C active medical device?\\n\\nExamples: syringes and administration sets for infusion pumps, anaesthesia breathing circuits\\n\\nNote: \\\"Connection\\\" to an active device covers those circumstances where the safety and performance of the active device is influenced by the non-active device and vice versa.\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7N8N9N10N11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N8N9N10N11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N10N11Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 2i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N10N11N\":{\"content\":\"Is the non-invasive device intended for any of the following?\\n\\nChannelling blood or blood components\\nStoring organs, parts of organs or body tissues\\nExamples: tubes used for blood transfusion, organ storage containers\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5N6Y7N8N9N10N11Y12Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5N6Y7N8N9N10N11Y12N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N10N11Y12Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 2ii.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6Y7N8N9N10N11Y12N\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>Examples: administration sets for gravity infusion, syringes without needles.<br>The risk classification above is based on Part II, Appendix 1 rule 2i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5N6N\":{\"content\":\"<h3>Sorry, we were unable to classify your device.<\\\/h3><p>You may wish to:<br>Review your answers<br>Check if your product is a medical device<br>Refer to our risk classification guide<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N\":{\"content\":\"Is the active device intended to control, monitor or directly influence the performance of an active therapeutic device?\\n\\nExamples: external feedback systems for active therapeutic devices\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 9ii.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N\":{\"content\":\"Is the device an active medical device intended for diagnosis?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y\":{\"content\":\"Is the active medical device intended to emit ionising radiation and intended for diagnostic or interventional radiology, including devices which control or monitor such devices, or those which directly influence their performance?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8Y9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 10ii.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N\":{\"content\":\"Is the device intended to supply energy which will be absorbed by the human body such as magnetic resonance energy or ultrasound waves?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y9N10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8Y9N10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10Y\":{\"content\":\"Is the device used solely to illuminate the patient's body, with visible light or near infra-red spectrum?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y9N10Y11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8Y9N10Y11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10Y11Y\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 10i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10Y11N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>Examples: magnetic resonance equipment, diagnostic ultrasound in non-critical applications, evoked response stimulators.<br>The risk classification above is based on Part II, Appendix 1 rule 10i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N\":{\"content\":\"Is the device intended to image the distribution of radiopharmaceuticals in the human body (in vivo distribution)?\\n\\nExample: gamma or nuclear cameras\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y9N10N11Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8Y9N10N11N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N11Y\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 10i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N11N\":{\"content\":\"Is the device intended to allow direct diagnosis or monitoring of vital physiological processes?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y9N10N11N12Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8Y9N10N11N12N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N11N12N\":{\"content\":\"<h3>Sorry, we were unable to classify your device.<\\\/h3><p>You may wish to:<br>Review your answers<br>Check if your product is a medical device<br>Refer to our risk classification guide<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N11N12Y\":{\"content\":\"Could the variations of the monitoring parameters OR diagnosing in clinical situations result in immediate danger to the patient?\\n\\nExamples: monitors or alarms for intensive care, biological sensors, oxygen saturation monitors, apnoea monitors, ultrasound equipment for use in interventional cardiac procedures\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8Y9N10N11N12Y13Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8Y9N10N11N12Y13N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N11N12Y13Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 10i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8Y9N10N11N12Y13N\":{\"content\":\"<h3>Your device's risk classification is Class B.<\\\/h3><p>Example: electronic thermometers, stethoscopes and blood pressure monitors, electrocardiographs.<br>The risk classification above is based on Part II, Appendix 1 rule 10i.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8N\":{\"content\":\"Is the active medical device intended to administer or remove medicines (therapeutic products), body liquids or other substances to or from the body?\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8N9Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8N9N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8N9N\":{\"content\":\"<h3>Your device's risk classification is Class A.<\\\/h3><p>Examples: examination lamps, surgical microscopes, powered hospital beds &amp; wheelchairs, powered equipment for the recording, processing, viewing of diagnostic images, dental curing lights.<br>The risk classification above is based on Part II, Appendix 1 rule 12.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8N9Y\":{\"content\":\"Considering the nature of the substances involved, the part of the body concerned and the mode and route of administration, could the administration or removal of these substances be done in a potentially hazardous manner?\\n\\nExamples: infusion pumps, anaesthesia equipment, dialysis equipment, hyperbaric chambers, nebuliser where the failure to deliver the appropriate dosage characteristics could be hazardous\",\"type\":\"question\",\"opt1_text\":\"Yes\",\"opt1_target\":\"1N2N3N4N5Y6N7N8N9Y10Y\",\"opt2_text\":\"No\",\"opt2_target\":\"1N2N3N4N5Y6N7N8N9Y10N\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8N9Y10Y\":{\"content\":\"<h3>Your device's risk classification is Class C.<\\\/h3><p>The risk classification above is based on Part II, Appendix 1 rule 11.<\\\/p>\",\"type\":\"result\",\"opt1_text\":\"\",\"opt1_target\":\"\",\"opt2_text\":\"\",\"opt2_target\":\"\",\"opt3_text\":\"\",\"opt3_target\":\"\"},\"1N2N3N4N5Y6N7N8N9Y10N\":{\"content\":\"Your device's risk classification is Class B.\\nExamples: suction equipment, feeding pumps, jet injectors for vaccination, nebuliser to be used on conscious and spontaneously breathing patients where failure to deliver the appropriate dosage characteristics is not potentially hazardous.\\n\\nThe risk classification above is based on Part II, Appendix 1 rule 11.\",\"type\":\"result\",\"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 class=\"mtk1\"><\/span><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":234,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-2287","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages\/2287","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/comments?post=2287"}],"version-history":[{"count":3,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages\/2287\/revisions"}],"predecessor-version":[{"id":2296,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages\/2287\/revisions\/2296"}],"up":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages\/234"}],"wp:attachment":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media?parent=2287"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}