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.