The Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter referred to as “the Act”).
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, pathology, and genetics devices
3.Immunology and microbiology devices
7.Ear, nose, and throat devices
8.Gastroenterology and urology devices
9.General, plastic surgery, and dermatology devices
10.General hospital and personal use devices
12.Obstetrical and gynecological devices
15.Physical medicine devices
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
Product items of the medical device classification are specified in the Annex.
Medical 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:
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 class as the particular medical device, unless otherwise specified in the Annex of the preceding paragraph.
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, 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.
Medical device firms or the public may make an inquiry to the central competent authority regarding the 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 as well.
2.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.
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.
If 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.
If 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.
The 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.