Quy định của FDA - Mỹ về thiết bị y tế

FDA (Cục quản lý Thực phẩm và Dược phẩm Hoa Kỳ) quy định sản phẩm thiết bị y tế là sản phẩm có mục đích sử dụng cho việc chẩn đoán, điều trị, làm giảm nhẹ, chữa trị hay ngăn ngừa bệnh tật có thể ảnh hưởng đến cấu trúc hay bất kì chức năng nào trên cơ thể người hoặc động vật.


Cục quản lý Thực phẩm và Dược phẩm Hoa Kỳ

Việc đăng kí thiết bị y tế và danh mục sản phẩm  
FDA yêu cầu chủ sở hữu hoặc điều hành cơ sở có liên quan đến việc sản xuất hay phân phối thiết bị y tế có mục đích sử dụng tại Mỹ phải đăng kí thường niên với họ. Những cơ sở sản xuất, đóng gói, dán nhãn hoặc tái chế thiết bị y tế phải trả phí thường niên. FDA yêu cầu nhiều cơ sở sản xuất phải đăng kí cơ sở cũng như liệt kê sản phẩm của họ.
Kiểm duyệt quản lý và đăng kí 510(k)
Ngoài việc đăng kí cơ sở sản xuất và danh mục sản phẩm thiết bị y tế, một số thiết bị y tế nhất định có yêu cầu phải được FDA thông qua trước khi được bán tại thị trường Mỹ. Để nhận được sự thông qua đó, các công ty phải đăng kí những thông tin khoa học và công nghệ đầy đủ để minh chứng cho việc sản phẩm của họ thực chất tương đương với một thiết bị đã được chính thực cho phép buôn bán ở thị trường Mỹ.

Quy trình đăng ký FDA

Đăng kí Quản lý thiết bị y tế (MAF) 
Đăng kí quản lý thiết bị y tế cho FDA là việc có thể sử dụng để hỗ trợ việc đăng kí trước khi sản phẩm cung cấp cho thị trường để bổ sung những thông tin chi tiết về cở sản xuất, chế biến hay sản phẩm được dùng trong việc sản xuất, chế biến, đóng gói và lưu trữ một hay nhiều thiết bị y tế. Đội ngũ chuyên gia tư vấn cung cấp những hướng dẫn yêu cầu về yếu tố cần thiết, định dạng và đặc thù của việc đăng kí quản lý thiết bị y tế.
Kiểm duyệt và thiết kế đồ họa nhãn mác thiết bị y tế
Hơn 22% những lô hàng bị lưu giữ tại Mỹ là do những sai phạm trong việc đóng gói nhãn mác. Các công ty thay đổi nhãn mác phù hợp với yêu cầu của FDA. Cần có các tập tin đồ họa đã chỉnh sửa để in ấn hoặc thay đổi, kèm theo một báo cáo chi tiết về luật và những hướng dẫn thích hợp, những bức thư cảnh báo, cảnh báo nhập khẩu và những tài liệu hướng dẫn khác từ U.S FDA.

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