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Regulations Governing the Classification of Medical Devices (Draft)

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Regulations Governing the Classification of Medical Devices (Draft) Article 1 These Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter “this Act”). Article 2 Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty: 1. Clinical chemistry and clinical toxicology devices 2. Hematology and pathology devices 3. Immunology and microbiology devices 4. Anesthesiology devices 5. Cardiovascular devices 6. Dental devices 7. Ear, nose, and throat devices 8. Gastroenterology and urology devices 9. General and plastic surgery devices 10. General hospital and personal use devices 11. Neurological devices 12. Obstetrical and gynecological devices 13. Ophthalmic devices 14. Orthopedic devices 15. Physical medicine devices 16. Radiology devices Article 3 Medical devices are classified into the following classes according to their risk level: 1. Class I: Low risk 2. Class II: Medium risk 3. Class III: High risk 1 Article 4 Product items of the medical device classification are specified in the Annex. In addition to rules stated in the Annex, medical devices whose function, intended use, or working principle are special may have their classification determined according to the following rules: 1. If two or more categories, classes, or product items are applicable to the same medical device, the highest class of risk level is assigned. 2. The accessory to a medical device, intended specifically by the manufacturer for use with a particular medical device, is classified the same as the particular medical device, unless otherwise specified in the Annex. 3. The classification of a combined product, which contains two or more medical devices packaged together while having two or more categories, classes, or product items applicable, is assigned the highest class of risk level among these devices. 4. A medical device containing medicine while having the primary mode of action of a medical device is determined to be a Class III medical device, unless otherwise specified in the Annex. Article 5 Medical device firms or the public may make an inquiry to the central competent authority regarding classification of medical devices or other relevant matters. Inquirers of the preceding paragraph shall fill out an inquiry form, provide the following related documents and information, and pay the required fees for submission to the central competent authority: 1. Instructions for use of the manufacturer: including operating instructions, function, and working principle. If they are not in the traditional Chinese or English version, a translation copy in traditional Chinese or English shall be provided separately. 2. Other reference information: Reference information from the United States of America, European Union, or other countries on the classification of the inquired product. If such reference information is not available, it is not required to be provided. In addition to the above documents and information, when necessary, the central competent authority may request the inquirer to provide other relevant documents and information. 2 Article 6 If the function, intended use, or working principle of the medical device does not meet identification criteria of the product items listed in the Annex, its classification shall be determined to be a Class III medical device. However, if a similar product has received license or been listed domestically, its classification shall be determined according to the risk level of the similar product, or if a classification inquiry has been made to the central competent authority in accordance with the provisions of the preceding paragraph, it shall be determined according to the risk level as responded by the central competent authority. Article 7 These Regulations shall enter into force from the effective date of this Act. 3 Annex Classification Classification Name Class Identification Number A.0001 Phencyclidine test system 2 Phencyclidine test system is a device to measure the concentration of Phencyclidine (an anesthetic agent) or Phencyclidine analog in blood, urine, or/and stomach contents. This device is to monitor the concentration of Phencyclidine or Phencyclidine analog in diseases treatment or diagnosis. A.0002 Clinical Chemistry Electrolyte System 1 Clinical chemistry electrolyte system is intended to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of electrolytes and other ions in a clinical specimen. A.1020 Acid phosphatase (total or prostatic) test 2 An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid system phosphatase enzyme in plasma and serum. A.1025 Adrenocorticotropic hormone (ACTH) 2 An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone test system in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. A.1030 Alanine amino transferase (ALT/SGPT) 1 An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme test system alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. A.1035 Albumin test system 2 An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. A.1040 Aldolase test system 1 An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy. A.1045 Aldosterone test system 2 An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance. A.1050 Alkaline phosphatase or isoenzymes test 2 An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its system isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. 1/222 A.1055 Newborn screening test system for amino 2 A newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass acids, free carnitine, and acylcarnitines spectrometry is a device that consists of stable isotope internal standards, control materials, extraction solutions, using tandem mass spectrometry. flow solvents, instrumentation, software packages, and other reagents and materials. The device is intended for the measurement and evaluation of amino acids, free carnitine, and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of amino acids, free carnitine, and acylcarnitines and their relationship with each other provides analyte concentration profiles that may aid in screening newborns for one or more inborn errors of amino acid, free carnitine, and acyl-carnitine metabolism. A.1060 Delta-aminolevulinic acid test system 1 Adelta -aminolevulinic acid test system is a device intended to measure the level ofdelta -aminolevulinic acid (a precursor of porphyrin) in urine.Delta -aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds includingdelta -aminolevulinic acid). A.1065 Ammonia test system 1 An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome. A.1070 Amylase test system 2 An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). A.1075 Androstenedione test system 1 An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production. A.1080 Androsterone test system 1 An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and
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