THIẾT BỊ SPA CÓ PHẢI TBYT

THIẾT BỊ SPA CÓ PHẢI THIẾT BỊ Y TẾ ?

AIRSEAGLOBAL GROUP

Gần đây, nhiều anh chị có hàng bị vướng cảng tìm đến Airseaglobal với vấn đề: “MÁY SPA VỀ BỊ HẢI QUAN ĐÒI CÔNG BỐ B, VƯỚNG CẢNG KHÔNG THÔNG QUAN ĐƯỢC?”

Tình trạng này, Thúy 0979785886 thấy có 2 nguyên nhân chính như sau:

  • Mặt hàng máy spa không thuộc thông tư 30, nên trước đây chỉ cần bản phân loại là nhập được. Tuy nhiên, Nghị định 98 bắt đầu có hiệu lực từ 01/01/2022 nên TẤT CẢ HÀNG LOẠI B PHẢI CHUYỂN QUA CÔNG BỐ B. Do quý anh chị chưa cập nhật được tình hình này nên chưa làm công bố B trước khi cho hàng về.

=> Anh chị liên hệ em Thúy 0979785886 làm nhanh chuẩn công bố B cho anh/chị ạ.

  • TH thứ hai là anh chị không biết MÁY SPA CÓ THỂ THUỘC THIẾT BỊ Y TẾ. Rất nhiều anh chị thắc mắc vấn đề này, các anh chị cho rằng máy spa của mình không phải TBYT và thực chất một số hàng spa ở nước ngoài không được phân loại là TBYT.

Để xác định một loại máy spa có phải thiết bị y tế hay không, anh chị hãy căn cứ vào CFS, ISO, HDSD và catalogue của sản phẩm nhé ạ!

Theo em, nếu các sản phẩm sử dụng công nghệ như sóng siêu âm, laser,… các công nghệ có tác dụng “điều trị” và xâm lấn vào cơ thể, da mặt thì Hải quan sẽ phân là thiết bị y tế. Các thiết bị chỉ mang tính chăm sóc ngoài da, tác dụng nhiệt (làm lạnh, nóng bề mặt) thì sẽ không phải là thiết bị y tế.

Tuy nhiên, tùy vào Hải quan họ sẽ yêu cầu khác nhau. Hiện chưa có công văn hay điều luật nào để doanh nghiệp có thể dựa vào để chứng minh sản phẩm spa của mình không phải là thiết bị y tế.

NHẬN TƯ VẤN QUA ZALO
proflie

Ngoài ra, mời anh chị tham khảo các bộ GPNK/ Lưu hành mà Airseaglobal Group đã làm tại đây: https://thutucnhapkhauthietbiyte.com.vn/gioi-thieu/

EM THÚY HƯỚNG DẪN CHECK SOÁT HỒ SƠ ĐĂNG KÝ LƯU HÀNH TỪ CHI TIẾT VÀ HẠN CHẾ PHẢN HỒI – ĐỐI VỚI TBYT LOẠI C, D

QUY TRÌNH CẤP SỐ ĐĂNG KÝ LƯU HÀNH C,D MỚI NHẤT

Hotline:0979785886 (zalo/tel) – Ms THÚY – Sales Manager
Mail: thuynt@airseaglobalgroup.com.vn
Add: P2414; 2412 Tòa Eurowindown, 27 Trần Duy Hưng, Cầu Giấy, Tp. Hà
Nội, Việt Nam

AIRSEAGLOBAL GROUP
VUA DỊCH VỤ NHẬP KHẨU THIẾT BỊ Y TẾ
Đảm bảo – Uy tín -Nhanh chóng

CÁC DỊCH VỤ CUNG CẤP:

  1. DỊCH VỤ HỖ TRỢ NHẬP KHẨU TBYT
    – VẬN CHUYỂN QUỐC TẾ, XỬ LÝ HÀNG VƯỚNG CẢNG CASE KHÓ
    – THÔNG QUAN MỞ TỜ KHAI CHỈ TỪ 700k/tờ khai (Tư vấn thuế nhập khẩu, thuế VAT, CO ưu đãi thuế)
    – Công bố tiêu chuẩn áp dụng đối với TBYT loại A, B
    – Đăng ký mới- soát sửa lưu hành C, D, Hồ sơ CSDT, thẩm định CSDT ( kinh nghiệm >1000 hồ sơ )
    – Công bố đủ điều kiện mua bán TBYT loại BCD (Chuẩn vào thầu)
    – Xin cấp mã hãng nước sản xuất, mã VTYT theo QĐ 5086, Quảng cáo TBYT, kê khai giá
  1. DỊCH VỤ HỖ TRỢ SẢN XUẤT VÀ XUẤT KHẨU TBYT:
    – Tư vấn và xin chứng nhận ISO 13485; ISO 22000; HACCP
    – Công bố đủ điều kiện sản xuất TTBYT
    – Công bố tiêu chuẩn áp dụng TBYT loại A,B
    – Đăng ký chứng chỉ lưu hành tự do (CFS), CE, FDA
  1. DỊCH VỤ CÔNG BỐ MỸ PHẨM, THỰC PHẨM BẢO VỆ SỨC KHỎE

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