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THỦ TỤC ĐĂNG KÝ LƯU HÀNH MÁY THỞ CAO TẦN – MS TUYẾT MINH 0971 460 378

Dự kiến năm 2023, cơ chế cấp số lưu hành sẽ chuyển từ tiền kiểm sang hậu kiểm. Đây có thể coi là tín hiệu tích cực cho các doanh nghiệp đang treo hồ sơ xin cấp giấy phép lưu hành. Với giải pháp này sẽ giải quyết được khoảng 70% hồ sơ đang tồn đọng, trong đó tập trung ưu tiên xem xét các hồ sơ thuộc trường hợp cấp nhanh theo Nghị định 98.

Với kinh nghiệm và góc độ của em Minh, đây là thời điểm VÀNG để các Doanh nghiệp nhanh chóng hoàn thiện bộ hồ sơ để kịp xử lý, ra số lưu hành vào năm 2023.

Nay em Tuyết Minh 0971 460 378 xin phép chia sẻ cho các bác Các bước để đăng ký Lưu hành Máy thở cao tần :

BƯỚC 1: RÀ SOÁT HỒ SƠ PHÁP LÝ

Rà soát các tài liệu do Hãng cung cấp là bước quan trọng đảm bảo hồ sơ không bị mất thời gian chỉnh sửa, làm chậm quá trình xin cấp hồ sơ lưu hành:

1, ISO 13485

Yêu cầu:

  • Iso còn hạn tại thời điểm nộp
  • Hồ sơ bằng tiếng anh hoặc tiếng việt (dịch công chứng)
  • Ghi đầy đủ thông tin nhà sản xuất, địa chỉ
  • Phạm vi sản xuất: bao gồm trang thiết bị y tế đăng ký lưu hành

2, Chứng nhận lưu hành tự do – Free sale certificate

Yêu cầu:

  • Được hợp thức hóa lãnh sự
  • Ghi đầy đủ thông tin nhà sản xuất, chủ sở hữu, tên sản phẩm, chủng loại
  • Trên Chứng nhận lưu hành tư do phải ghi rõ “sản phẩm được lưu hành tại thị trường nội địa và không hạn chế xuất khẩu”

3, Ủy quyền Authorization (consular authetication)

Yêu cầu:

  • Làm theo mẫu do Bộ y tế ban hành
  • Được hợp thức hóa lãnh sự

4, Bảo hành hoặc xác nhận hàng dùng 1 lần:

Yêu cầu:

  • Làm theo mẫu do Bộ y tế ban hành
  • Được hợp thức hóa lãnh sự

5, Hướng dẫn sử dụng

Yêu cầu: Hướng dẫn sử dụng gốc của nhà sản xuất

6, Tem nhãn hàng gốc:

Yêu cầu: Scan màu ĐẦY ĐỦ mẫu nhãn của từng chủng loại sản phẩm, từng quy cách đóng gói

7, Hồ sơ giấy chứng nhận hoặc tuyên bố phù hợp với các tiêu chuẩn

BƯỚC 2: RÀ SOÁT HỒ SƠ KỸ THUẬT

Hồ sơ kỹ thuật kể đến các báo cáo lâm sàng, mô tả kỹ thuật và catalogue

BƯỚC 3: PHÂN LOẠI VÀ PHÂN NHÓM: AIRSEAGLOBAL hỗ trợ Phân loại chuẩn TT 05

Máy thở cao tần: loại C

BƯỚC 4: PHÂN LUỒNG LƯU HÀNH:

Với các hồ sơ đủ điều kiện cấp nhanh, AIRSEAGLOBAL hỗ trợ rà soát theo quy định

Tham khảo: ĐIỀU KIỆN CẤP NHANH SỐ LƯU HÀNH ĐỐI VỚI TRANG THIẾT BỊ Y TẾ LOẠI C, D: tại đây 

BƯỚC 5: NỘP LƯU HÀNH VÀ CHỜ PHẢN HỒI: AIRSEAGLOBAL chuẩn hóa và hoàn thiện form mẫu, nộp

 AIRSEAGLOBAL HỖ TRỢ QUÝ KHÁCH HÀNG:

  • CHECK SOÁT HỒ SƠ LƯU HÀNH (MIỄN PHÍ)
  • DỊCH THUẬT TÀI LIỆU KỸ THUẬT
  • PHÂN LOẠI CHUẨN LƯU HÀNH
  • NỘP HỒ SƠ LƯU HÀNH
  • THEO DÕI TIẾN ĐỘ
  • THEO DÕI PHẢN HỒI LƯU HÀNH TỪ BỘ Y TẾ
Tham khảo: 16 LỐI SAI KHIẾN HỒ SƠ LƯU HÀNH C,D BỊ CHẬM DOANH NGHIỆP NÊN TRÁNH: tại đây

MỌI THẮC MẮC XIN LIÊN HỆ MS TUYẾT MINH AIRSEAGLOBAL – 0971 460 378

Zalo: 0971 460 378

Mobi: 0971 460 378

Email: minhtt@airseaglobalgroup.com.vn

AIRSEAGLOBAL – VUA DỊCH VỤ NHẬP KHẨU THIẾT BỊ Y TẾ

  1. Xử lý GIẤY PHÉP chỉ từ 3-5 ngày:
  • Phân loại (Chỉ từ 200k – Chuẩn vào thầu)
  • Công bố tiêu chuẩn áp dụng đối với TBYT loại A, B
  • Đăng ký Lưu hành thiết bị y tế BCD (Chuẩn vào thầu)
  • Công bố đủ điều kiện mua bán TBYT loại BCD (Chuẩn vào thầu)
  • Công bố đủ điều kiện sản xuất, ISO 13485, ISO 9001, CFS
  1. THÔNG QUAN MỞ TỜ KHAI CHỈ TỪ 700k/tờ khai.
  2. Vận chuyển quốc tế, trucking nội địa giá SIÊU TỐT, SIÊU NHANH

Em Tuyết Minh hoàn tiền 100% nếu hồ sơ thầu ko đạt chuẩn vào thầu; hoàn tiền 100% phí phát sinh hải quan cho khách làm Full dịch vụ từ giấy phép, Hải quan, Vận chuyển Fob/ Exw Air/ Sea với Airseaglobal nếu do lỗi sai giấy phép hoặc soát chứng từ bên em – Bên em thuộc WCA member ID 73213

Update Tuyết Minh

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