z3004405680545_1ae5eda0a911bd1d85e5c6e804e650ad

NĂM 2022, TBYT LOẠI B ĐƯỢC NHẬP KHẨU NHƯ THẾ NÀO ?

AIRSEAGLOBAL GROUP

👉TBYT LOẠI B CHUYỂN SANG XIN CÔNG BỐ TIÊU CHUẨN ÁP DỤNG TẠI SỞ Y TẾ

👉VẬY BỘ HỒ SƠ CÔNG BỐ TBYT LOẠI B CHUẨN CHỈNH THEO NĐ 98/2021/NĐ-CP GỒM NHỮNG GÌ ????

Em Minh sẽ giải đáp các thắc mắc trên giúp anh chị:

🎯Sang năm 2022, Trang thiết bị y tế loại B thay vì xin số lưu hành thì sẽ chuyển sang Xin Số Công bố giống như Loại A, hồ sơ được xử lý bởi Sở y tế địa phương. (Loại C, D vẫn xin số lưu hành.)

🎯Bộ hồ sơ chuẩn chỉnh đối với Doanh nghiệp tiến hành Công bố tiêu chuẩn áp dụng TBYT loại B gồm:

✔1. Văn bản công bố tiêu chuẩn áp dụng của trang thiết bị y tế thuộc loại 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
✔4. Giấy xác nhận đủ điều kiện bảo hành , trừ trường hợp trang thiết bị y tế sử dụng một lần 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, catalogue
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.
✔7. Tài liệu hướng dẫn sử dụng của trang thiết bị y tế tiếng Việt + bản gốc tiếng Anh của bên bán
✔8. Mẫu nhãn sẽ sử dụng khi lưu hành tại Việt Nam của trang thiết bị y tế + Nhãn gốc thực tế của bên bán
✔9. Giấy chứng nhận lưu hành tự do (CFS) còn hiệu lực tại thời điểm nộp hồ sơ đối với trang thiết bị y tế nhập khẩu.

👉👉Anh chị cần tư vấn trọn bộ thủ tục nhập khẩu thiết bị y tế: Phân loại, Công bố, Lưu hành,… liên hệ:

Anh / Chị cần hỗ trợ chuẩn hóa hồ sơ Lưu hành TTBYT, giấy phép – thông quan – vận chuyển TTBYT, 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

Các dịch vụ cung cấp:

  • Phân loại (Chỉ từ 400k – Chuẩn vào thầu – Được phân loại lại 1 lần miễn phí)
  • Xin Công bố đủ điều kiện kinh doanh thiết bị y tế loại BCD (Chuẩn vào thầu)
  • Xin Công bố tiêu chuẩn áp dụng đối với trang thiết bị y tế loại A
  • Xin giấy phép nhập khẩu thông tư 30
  • Xin đăng ký lưu hành thiết bị y tế BCD nhập khẩu, sản xuất trong nước (Chuẩn vào thầu)
  • Xin công bố đủ điều kiện sản xuất
  • Dịch vụ làm chứng chỉ lưu hành tự do cho hàng loại ABCD sản xuất trong nước.
  • Dịch vụ làm ISO 13485, ISO 9001,…sản xuất trong nước
  • Tư vấn miễn phí Luật đấu thầu mới theo TT14, Phân nhóm, Uỷ quyền, giấy tờ… (Thông tư 14 hiệu lực từ 01.09.2020)
  • Vận chuyển quốc tế, trucking nội địa, thông quan, xử lý VAT 5 TBYT

Update Tuyết Minh

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