HỒ SƠ ISO 13485 MỚI

GIẤY CHỨNG NHẬN, HỒ SƠ LÀM ISO 13485 CHO DOANH NGHIỆP SẢN XUẤT THIẾT BỊ Y TẾ

1/ ISO 13485 LÀ GÌ?

Chứng nhận ISO 13485 sản xuất thiết bị y tế trong nước là những tiêu chuẩn quốc tế về hệ thống quản lý an toàn cho các sản phẩm về thiết bị y tế nằm trong bộ tiêu chuẩn ISO 13485:2016 do tổ chức ISO ban hành và quy định, tương đương với tiêu chuẩn quốc gia tại Việt Nam là TCVN ISO 13485:2017

2/ AI PHẢI LÀM Chứng nhận ISO 13485 sản xuất thiết bị y tế trong nước?

Theo Nghị định Chính phủ 36/2016/NĐ_CP ngày 15/5/2016 quy định: áp dụng ISO 13485 là một trong những yêu cầu BẮT BUỘC đối với các doanh nghiệp kinh doanh, sản xuất trong lĩnh vực trang thiết bị y tế.

3/ LỢI ÍCH KHI LÀM Chứng nhận ISO 13485 sản xuất thiết bị y tế trong nước?

Tầm quan trọng và lợi ích rõ rệt nhất khi doanh nghiệp áp dụng tiêu chuẩn ISO 13485:2017: 

  • Cung cấp sản phẩm an toàn cho người sử dụng
  • Tạo lợi thế cạnh tranh, nâng cao thương hiệu, có thể dễ dàng xuất khẩu
  • Nâng cao khả năng đáp ứng các yêu cầu của khách hàng. Đáp ứng luật định của quốc gia, quốc tế cho các sản phẩm y tế
  • Nâng cao năng lực cạnh tranh cho doanh nghiệp và mở rộng thị trường

4/ HỒ SƠ LÀM ISO 13485 CHO DOANH NGHIỆP SẢN XUẤT TBYT CẦN NHỮNG GIẤY TỜ GÌ?

  • Đăng ký kinh doanh
  • Hình ảnh nhà xưởng, cơ sở sản xuất
  • Để làm ISO 13485 cho doanh nghiệp sản xuất TBYT liên hệ em Thúy 0979785886 ạ.

? Hiệu lực của ISO 13485: 3 năm kể từ ngày cấp

Anh/chị cần làm mới ISO 13485 đã hết hạn liên hệ em Thúy 0979785886TRỌN GÓI giấy tờ cho hàng sản xuất trong nước

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
proflie

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