醫療器材分類分級管理辦法

The Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter referred to as “the Act”).

1Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty:

21.Clinical chemistry and clinical toxicology devices

32.Hematology, pathology, and genetics devices

43.Immunology and microbiology devices

54.Anesthesiology devices

65.Cardiovascular devices

76.Dental devices

87.Ear, nose, and throat devices

98.Gastroenterology and urology devices

109.General, plastic surgery, and dermatology devices

1110.General hospital and personal use devices

1211.Neurological devices

1312.Obstetrical and gynecological devices

1413.Ophthalmic devices

1514.Orthopedic devices

1615.Physical medicine devices

1716.Radiology devices

1Medical devices are classified into the following classes according to their risk level:

21.Class I: Low risk

32.Class II: Medium risk

43.Class III: High risk

1Product items of the medical device classification are specified in the Annex.

2Medical device, except that it can be classified into anyone product item in the Annex of the preceding paragraph, may be classified its class according to the following rules with its special function, intended use, or working principle:

31.If two or more categories, classes, or product items are applicable to the same medical device, the highest class of risk level is assigned.

42.The accessory to a medical device, intended specifically by the manufacturer for use with a particular medical device, is classified the same class as the particular medical device, unless otherwise specified in the Annex of the preceding paragraph.

53.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.

64.A medical device containing medicine, which its primary mode of action is attributable to its medical device, is determined to be a Class III medical device, unless otherwise specified in the Annex of the preceding paragraph.

1Medical device firms or the public may make an inquiry to the central competent authority regarding the classification of medical devices or other relevant matters.

2Inquirers 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:

31.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 as well.

42.Classification 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.

5In addition to the above documents and information, when necessary, the central competent authority may request the inquirer to provide other relevant documents and information.

1If the function, intended use, or working principle of a medical device does not meet identification criteria of any product item listed in the Annex, its classification shall be determined to be a Class III medical device.

2If a predicate device has been approved in registration or listed domestically, its classification shall be determined according to the risk level of the predicate device, 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.

1The Regulations shall enter into force on May 1, 2021, excluding classification numbers “A.3652”, “C.3372”, and “C.3970” from the Annex which shall be effective on July 1, 2022.

2The amendments to the Annex to Article 4 shall enter into force on August 22, 2023, excluding classification numbers “D.1100”, “J.5780”, and “M.5844” from the Annex which shall be effective on August 22, 2025 and classification number “I.4040” from the Annex which shall be effective on August 22, 2026.