dang ky luu hanh bom tiem dien

THỦ TỤC NHẬP KHẨU – ĐĂNG KÝ LƯU HÀNH BƠM TIÊM ĐIỆN

Từ 1.1.2023 Bơm tiêm điện phân loại C muốn nhập khẩu về cần có số lưu hành.

Bơm tiêm điện được xét cấp khẩn cấp số lưu hành theo Danh mục Thiết bị y tế phục vụ phòng – chóng COVID (Thông tư 06/2022/TT –  BYT)

Cơ quan cấp phép: Vụ trang thiết bị và công trình y tế (Bộ y tế)

Các bước chuẩn bị và xin cấp phép Lưu hành như sau:

BƯỚC 1: RÀ SOÁT HỒ SƠ PHÁP LÝ

Rà soát các tài liệu do Hãng cung cấp là bước quan trọng đảm bảo hồ sơ không bị mất thời gian chỉnh sửa, làm chậm quá trình xin cấp hồ sơ lưu hành

  1. ISO 13485
    • Iso còn hạn tại thời điểm nộp
    • Hồ sơ bằng tiếng anh hoặc tiếng việt (dịch công chứng)
    • Ghi đầy đủ thông tin nhà sản xuất, địa chỉ
    • Phạm vi sản xuất: bao gồm trang thiết bị y tế đăng ký lưu hành
  2. Chứng nhận lưu hành tự do – Free sale certificate
    • Được hợp thức hóa lãnh sự
    • Ghi đầy đủ thông tin nhà sản xuất, chủ sở hữu, tên sản phẩm, chủng loại
    • Trên Chứng nhận lưu hành tư do phải ghi rõ “sản phẩm được lưu hành tại thị trường nội địa và không hạn chế xuất khẩu”
    • Tham khảo MẪU CFS BỘ Y TẾ CUNG CẤP TẠI ĐÂY
  3. Ủy quyền
    • Làm theo mẫu do Bộ y tế ban hành
    • Được hợp thức hóa lãnh sự
  4. Bảo hành:
    • Làm theo mẫu do Bộ y tế ban hành
    • Được hợp thức hóa lãnh sự
  5. Hướng dẫn sử dụng:
    • Hướng dẫn sử dụng gốc của nhà sản xuất
    • Hướng dẫn sử dụng có các thông tin sau: mục đích sử dụng/ chỉ định, chống chỉ định (nếu có), cảnh báo, biện pháp phòng ngừa, tác dụng bất lợi (nếu có), cách sử dụng, điều kiện bảo quản, điều kiện sử dụng
  6. Tem nhãn hàng gốc:
    • Scan màu ĐẦY ĐỦ mẫu nhãn của từng chủng loại sản phẩm, từng quy cách đóng gói
  7. Hồ sơ giấy chứng nhận hoặc tuyên bố phù hợp với các tiêu chuẩn

BƯỚC 2: RÀ SOÁT HỒ SƠ KỸ THUẬT

Hồ sơ kỹ thuật kể đến các báo cáo lâm sàng, mô tả kỹ thuật và catalogue

BƯỚC 3: PHÂN LOẠI VÀ PHÂN NHÓM:

AIRSEAGLOBAL hỗ trợ Phân loại Thiết bị y tế chuẩn TT 05

BƯỚC 4: PHÂN LUỒNG LƯU HÀNH:

Với các hồ sơ đủ điều kiện cấp nhanh, AIRSEAGLOBAL hỗ trợ rà soát theo quy định

BƯỚC 5: NỘP LƯU HÀNH VÀ CHỜ PHẢN HỒI:

MỌI THẮC MẮC XIN LIÊN HỆ MS HIỀN 0988726654

MS HIỀN 0988726654 (zalo/tel)

hienbt@airseaglobalgroup.com.vn

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