Medical Device Exemptions 510(k) and GMP Requirements | 合法醫療器材資訊網
-
Introduction
Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.
Class I Devices
FDA has exempted almost all class I devices (with the exception of Reserved Devices[1] from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "#" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21...
ISO 20697 | 合法醫療器材資訊網
ISODIS 20697(en) | 合法醫療器材資訊網
ISO 20696 | 合法醫療器材資訊網
EN ISO 20697 | 合法醫療器材資訊網
Classification of medical devices | 合法醫療器材資訊網
Medical Device Exemptions 510(k) and GMP Requirements | 合法醫療器材資訊網
【"優勢益" 導入/引流導管及其附件 (未滅菌)】許可證字號:衛部醫器輸壹字第018164號
器材品名:"優勢益"導入/引流導管及其附件(未滅菌)許可證字號:衛部醫器輸壹字第018164號註銷狀態:註銷日期:註銷理由:有效日期...