z3336419250033_af3497d70c247f3d3e0e391bbba4e469

HỒ SƠ ĐĂNG KÝ LƯU HÀNH THIẾT BỊ Y TẾ LOẠI C,D

Em Tuyết Minh 0971460378 nhận làm hồ sơ đăng ký lưu hành thiết bị y tế loại C,D trên khắp cả nước

Hồ sơ đề nghị cấp mới số lưu hành đối với trang thiết bị y tế:

  1. Văn bản đề nghị cấp mới số lưu hành.
  2. Chứng chỉ ISO 13845
  3. Giấy ủy quyền của chủ sở hữu trang thiết bị y tế cho cơ sở thực hiện việc đăng ký lưu hành (Hợp pháp hóa, theo mẫu)
  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 (hợp pháp hóa, theo mẫu)
  5. CFS (hợp pháp hóa lãnh sự)
  6. Hồ sơ kỹ thuật chung về trang thiết bị y tế theo quy định của ASEAN (sau đây viết tắt là hồ sơ CSDT) sẽ áp dụng từ 01.01.2023. Trong 2022, mục này sẽ thay thế bằng các mục sau:
    6.1. 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 và kiểm soát chất lượng sản phẩm, các báo cáo nghiên cứu lâm sàng và tiền lâm sàng bao gồm báo cáo độ ổn định.
    6.2. Tài liệu hướng dẫn sử dụng của trang thiết bị y tế.
    6.3. Mẫu nhãn sẽ sử dụng khi lưu hành tại Việt Nam của trang thiết bị y tế.
  7. Chứng nhận hợp quy

Anh / Chị cần hỗ trợ chuẩn hóa giấy phép, thông quan, vận chuyển, thủ tục nhập khẩu THIẾT BỊ Y TẾ, liên hệ em Tuyết Minh nhé ạ!

Ms Tuyết Minh

Zalo/Tel: 0971.460.378 (zalo/tel)

Email: minhntt@airseaglobalgroup.com.vn

AIRSEAGLOBAL GROUP – THỦ TỤC NHẬP KHẨU THIẾT BỊ Y TẾ CHUYÊN NGHIỆP SỐ 1 VIỆT NAM

Em Tuyết Minh Airsea 0971460378 – NHẬN TRỌN GÓI DỊCH VỤ CHO THIẾT BỊ Y TẾ, VẬT TƯ Y TẾ, HÀNG NHA KHOA nhập khẩu/ sản xuất trong nước:

  1. Xử lý GIẤY PHÉP chỉ từ 3-5 ngày:
  • Phân loại (Chỉ từ 200k – Chuẩn vào thầu)
  • Công bố tiêu chuẩn áp dụng đối với TBYT loại A, B
  • Đăng ký Lưu hành thiết bị y tế BCD (Chuẩn vào thầu)
  • Công bố đủ điều kiện mua bán TBYT loại BCD (Chuẩn vào thầu)
  • Công bố đủ điều kiện sản xuất, ISO 13485, ISO 9001, CFS
  1. THÔNG QUAN MỞ TỜ KHAI CHỈ TỪ 700k/tờ khai.
  2. Vận chuyển quốc tế, trucking nội địa giá SIÊU TỐT, SIÊU NHANH

Em Tuyết Minh hoàn tiền 100% nếu hồ sơ thầu ko đạt chuẩn vào thầu; hoàn tiền 100% phí phát sinh hải quan cho khách làm Full dịch vụ từ giấy phép, Hải quan, Vận chuyển Fob/ Exw Air/ Sea với Airseaglobal nếu do lỗi sai giấy phép hoặc soát chứng từ bên em – Bên em thuộc WCA member ID 73213

Update Tuyết Minh

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