Hàng y tế vốn là mặt hàng đặc biệt bên cạnh những thủ tục, giấy tờ chuyên ngành: từ phân loại, công bố, đến số lưu hành thì các bác cũng cần lưu ý thường xuyên cập nhật những thay đổi về luật trong quy định nhập các mặt hàng này.
Ví dụ như 2022 trở về trước cùng một mặt hàng các bác phải làm GPNK( thời gian lâu, thủ tục phức tạp) nhưng từ năm 2022 lại chỉ cần làm công bố( nhanh chóng, hồ sơ ngắn gọn).
Vậy từ năm 2022, để có thể nhập khẩu, kinh doanh mặt hàng MÁY NỘI NHA, các doanh nghiệp cần chuẩn bị những gì?
Trả lời:
I. CĂN CỨ THEO LUẬT:
– Nghị định số 98/2021/NĐ-CP https://airseaglobal.com.vn/nghi-dinh-so-98-2021-nd-cp-ngay-8-11-2021-ve-quan-ly-trang-thiet-bi-y-te-ms-hien-0988726654/
– Thông tư 39/2016/TT-BYT https://airseaglobal.com.vn/thong-tu-39-2016-tt-byt-phan-loai-ttbyt/
II. BẢN CHẤT MẶT HÀNG
– Tên sản phẩm: MÁY NỘI NHA
– HS Code: 9018 4900
– Thuế NK: 0% Thuế VAT: ib em Hiền
– MÁY NỘI NHA là trang TBYT thuộc loại B (Theo Quy tắc 9, Phần II, Thông tư 39/2016/TT- BYT)
III. NHỮNG LƯU Ý TRƯỚC KHI NHẬP KHẨU
MÁY NỘI NHA Là trang thiết bị y tế loại B, thuộc quản lý của BYT. Đây là mặt hàng nhập khẩu có điều kiện. Vì vậy trước khi nhập khẩu, các doanh nghiệp cần tiến hành:
– Phân loại và công khai phân loại B
– Công bố tiêu chuẩn áp dụng loại B tại SYT (trước đây mặt hàng này có rủi ro phải cần xin GPNK gây nhiều khó khăn, tuy nhiên với luật mới thì đã là tạo điều kiện rất nhiều cho các DN nhập khẩu rồi nhé các bác)
– Với các doanh nghiệp kinh doanh, nhập khẩu trang TBYT loại B,C,D cần làm công bố đủ điều kiện mua bán BCD
– Kê khai giá là yêu cầu bắt buộc trước 01/04/2022 đối với các đơn vị nhằm quản lý giá về giá vốn, lợi nhuận, giá bán ra của các doanh nghiệp đối với tbyt đang lưu hành và trước khi đưa tbyt lần đầu lưu hành trên thị trường.
– Tem nhãn thực tế trên hàng phải chuẩn 100% với tất cả giấy tờ
IV. HỒ SƠ HẢI QUAN NHẬP KHẨU MÁY NỘI NHA:
Hồ sơ hải quan nhập khẩu MÁY NỘI NHA thông thường bao gồm bản scan nộp điện tử hoặc bản gốc của các giấy tờ sau:
– Commercial Invoice (Hóa đơn thương mại)
– Bill of lading (Vận đơn)
– Giấy giới thiệu – Bản chính
– Certificate of origin (Giấy chứng nhận xuất xứ) – Bản gốc hoặc bản điện tử trong trường hợp người nhập khẩu muốn được hưởng thuế nhập khẩu ưu đãi đặc biệt
– Packing List
– Phân loại TBYT & Công bố tiêu chuẩn loại B
MỌI THẮC MẮC VUI LÒNG LIÊN HỆ EM HIỀN ĐỂ ĐƯỢC TƯ VẤN THỦ TỤC XUẤT NHẬP KHẨU: 0988726654
Các bài viết tham khảo thêm:
1, Tải Full Nghị định 98/2021/NĐ-CP về quản lý trang TBYT: Tại đây
2, Bộ hồ sơ đăng ký lưu hành: Tại đây

EM HIỀN NHẬN FULL DỊCH VỤ HỖ TRỢ CHECK, CARE, XIN GIẤY PHÉP, VẬN CHUYỂN THÔNG QUAN, ĐƯA HÀNG VỀ KHO
TEL: 0988726654 – Sales Manager – Ms Hiền
Qúet Zalo
DỊCH VỤ LOGISTICS, THÔNG QUA, TƯ VẤN THỦ TỤC HÀNG Y TẾ VÀ THỦ TỤC CÁC MẶT HÀNG
1. Dịch vụ công bố TBYT loại A, B
2. Dịch vụ xin Lưu hành TBYT loại C,D
3. Dịch vụ Phân loại TBYT chuyên nghiệp
4. Dịch vụ tư vấn hồ sơ vào thầu TBYT
5. Dịch vụ Công bố mua bán TBYT loại BCD
6. Dịch vụ Xin GPNK các loại TBYT khác
7. Dịch vụ tư vấn các mặt hàng khác
8. Dịch vụ Vận chuyển AIR / SEA Quốc tế & Hải quan trọn gói
9. Dịch vụ tư vấn CFS quốc tế


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