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HỒ SƠ CÔNG BỐ TIÊU CHUẨN ÁP DỤNG VỚI TRANG TBYT LOẠI A,B – MS TRANG 0395646841

AIRSEAGLOBAL GROUP

Tới 01.01.2022 Bộ y tế sẽ áp dụng nộp công bố tiêu chuẩn áp dụng TBYT Loại B (hình thức Nộp trực tuyến qua cổng dịch vụ công), các anh chị lưu ý nhé ạ. Ngoài ra, theo Nghị định 98 về quản lí trang thiết bị y tế, vẫn áp dụng công bố với TBYT loại A nộp cho Sở y tế như cũ.

Em Trang – 0395646841 nhận tư vấn, hỗ trợ anh chị làm mới hồ sơ công bố tiêu chuẩn áp dụng TBYT loại A,B và lưu hành loại C, D trên khắp cả nước. Đảm bảo hồ ra chuẩn và nhanh nhất ạ.

👉 Hồ sơ công bố tiêu chuẩn áp dụng đối với trang thiết bị y tế thuộc loại A, B bao gồm:

1. Văn bản công bố tiêu chuẩn áp dụng của trang thiết bị y tế thuộc loại A, B.

2. Giấy chứng nhận đạt tiêu chuẩn quản lý chất lượng ISO 13485 còn hiệu lực tại thời điểm nộp hồ sơ.

3. Giấy ủy quyền của chủ sở hữu trang thiết bị y tế cho tổ chức đứng tên công bố tiêu chuẩn áp dụng còn hiệu lực tại thời điểm nộp hồ sơ

4. Giấy xác nhận đủ điều kiện bảo hành do chủ sở hữu trang thiết bị y tế cấp, trừ trường hợp trang thiết bị y tế sử dụng một lần theo quy định của chủ sở hữu trang thiết bị y tế hoặc có tài liệu chứng minh không có chế độ bảo hành.

5. Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế bằng tiếng Việt, kèm theo tài liệu kỹ thuật mô tả chức năng, thông số kỹ thuật của trang thiết bị y tế do chủ sở hữu trang thiết bị y tế ban hành.

Riêng đối với thuốc thử, chất hiệu chuẩn, vật liệu kiểm soát in vitro: tài liệu kỹ thuật bằng tiếng Việt kèm theo tài liệu về nguyên vật liệu, về an toàn của sản phẩm, quy trình sản xuất, các báo cáo nghiên cứu lâm sàng và tiền lâm sàng bao gồm báo cáo độ ổn định.

6. Giấy chứng nhận hợp chuẩn theo quy định hoặc bản tiêu chuẩn sản phẩm do chủ sở hữu trang thiết bị y tế công bố.

Riêng đối với trang thiết bị y tế sản xuất trong nước bổ sung kết quả đánh giá các thông số hóa, lý, vi sinh và các thông số khác do cơ sở đủ điều kiện theo quy định của pháp luật về đánh giá sự phù hợp cấp hoặc Giấy chứng nhận đánh giá chất lượng do cơ quan có thẩm quyền của Việt Nam cấp đối với trang thiết bị y tế chẩn đoán in vitro. Kết quả đánh giá phải phù hợp với tiêu chuẩn mà chủ sở hữu trang thiết bị y tế công bố.

7. Tài liệu hướng dẫn sử dụng của trang thiết bị y tế.

8. Mẫu nhãn sẽ sử dụng khi lưu hành tại Việt Nam của trang thiết bị y tế.

9. Giấy chứng nhận lưu hành tự do còn hiệu lực tại thời điểm nộp hồ sơ đối với trang thiết bị y tế nhập khẩu.

👉 Doanh nghiệp cần hỗ trợ thủ tục Nhập khẩu cho các loại hàng y tế thì liên hệ em tư vấn nhé:

Ms Trang: 0395.646.841 (zalo/tel)

Mail: trangnt@airseaglobalgroup.com.vn

Add: Phòng 2412 tòa Eurowindow 27 Trần Duy Hưng, Cầu Giấy, Hà Nội.

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