GIẤY TỜ LƯU HÀNH CHO SẢN XUẤT KHẨU TRANG, CỒN, NƯỚC MUỐI

GIẤY TỜ LƯU HÀNH CHO SẢN XUẤT KHẨU TRANG Y TẾ, NƯỚC MUỐI, CỒN

AIRSEAGLOBAL GROUP

Khẩu trang, nước muối….. dùng trong y tế hiện nay đang được sử dụng phổ biến ở trong các bệnh viện phòng khám cũng như ở các quầy thuốc. Hiện nay có rất nhiều doanh nghiệp đã và đang sản xuất các loại mặt hàng này. Năm 2024 thủ tục sản xuất nước muối sinh lý đã đơn giản hóa hơn nhiều, nhưng các Sở y tế sẽ đẩy mạnh khâu hậu kiểm hơn nên khi sản xuất doanh nghiệp cần đặc biệt lưu ý hoàn thành đầy đủ giấy tờ lưu hành. em Thúy 0979785886 xin phép gửi đến các bác giấy tờ như sau nhé ạ:

Theo quy định của pháp luật thì khi muốn đưa sản phẩm khẩu trang, nước muối….. dùng trong y tế thì các cơ sở sản xuất phải xin giấy tờ lưu hành đầy đủ như sau:

Bước 1: Thành lập công ty sản xuất trang thiết bị y tế tại Sở Kế hoạch và đầu tư nơi bạn đặt trụ sở kinh doanh

Bước 2: Xin giấy tờ chứng nhận đạt tiêu chuẩn quản lý chất lượng ISO 13485 cho khẩu trang, nước muối,….

Bước 3: Xin giấy tờ đủ điều kiện sản xuất khẩu trang, nước muối sinh lý,….(Công bố cơ sở đủ điều kiện sản xuất trang thiết bị y tế).

Bước 4: Kiểm nghiệm theo tiêu chuẩn của Bộ

Bước 5: Xin giấy tờ lưu hành cho khẩu trang y tế, nước muối,… (Công bố tiêu chuẩn loại A)


Anh chị cần tư vấn cụ thể hơn về các giấy tờ lưu hành cho sản xuất hàng khẩu trang y tế, nước muối,…. thì liên hệ em Thúy 0979785886

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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