Hồ sơ kỹ thuật chung ASEAN bắt buộc áp dụng từ ngày 01/01/2024 đã gây ra nhiều khó khăn cho doanh nghiệp trong quá trình đăng ký lưu hành thiết bị y tế loại C, D.
1. CSDT LÀ GÌ? KHI NÀO ÁP DỤNG HỒ SƠ CSDT?
Theo Nghị định 07/2023/NĐ-CP:
“Quy định về việc áp dụng Hồ sơ kỹ thuật chung về trang thiết bị y tế theo quy định của ASEAN (Common Submission Dossier Template – CSDT): Bắt buộc áp dụng hồ sơ CSDT từ ngày 01 tháng 01 năm 2024″
2. HỒ SƠ CSDT GỒM NHỮNG TÀI LIỆU NÀO? ĐƠN VỊ NÀO THẨM ĐỊNH HỒ SƠ CSDT?
Hồ sơ CSDT là thành phần hồ sơ bắt buộc trong Hồ sơ xin Đăng ký lưu hành trang thiết bị y tế loại C, D tại Việt Nam.
- Đối với hồ sơ đăng ký lưu hành luồng thường: nộp Kết quả thẩm định hồ sơ CSDT của đơn vị do Bộ trưởng Bộ Y tế chỉ định kèm theo hồ sơ CSDT.
- Đối với hồ sơ đăng ký lưu hành luồng nhanh: nộp Hồ sơ CSDT
Quyết định 04/QĐ-BYT về việc chỉ định đơn vị thẩm định hồ sơ kỹ thuật chung về trang thiết bị y tế theo quy định của ASEAN:
– Đối với TTBYT không phải TTBYT chuẩn đoán IVD: Viện Trang thiết bị và Công trình y tế
– Đối với TTBYT là TTBYT chuẩn đoán IVD: Viện Kiểm định Quốc gia Vắc xin và Sinh phẩm y tế
Bộ Y tế đã có Quyết định số 2426/QĐ-BYT Hướng dẫn chuẩn bị hồ sơ kỹ thuật chung ASEAN và Quyết định số 166/QĐ-BYT Về việc ban hành tiêu chí, nguyên tắc đánh giá hồ sơ kỹ thuật chung về thiết bị y tế theo quy định của ASEAN (Common Submission Dossier Template – CSDT) đối với thiết bị y tế không phải là thiết bị y tế in vitro
LÀM HỒ SƠ CSDT CẦN NHỮNG TÀI LIỆU NÀO?
Anh chị cần bản tiếng Anh của Quyết định 2426/QĐ-BYT, Quyết định 166/QĐ-BYT và Checklist hồ sơ CSDT bản tiếng Anh, vui lòng liên hệ Thúy em 0979785886
3. HỒ SƠ ĐỀ NGHỊ CẤP MỚI SỐ LƯU HÀNH THIẾT BỊ Y TẾ TỪ 2024
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:
- 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
- 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
- DỊCH VỤ CÔNG BỐ MỸ PHẨM, THỰC PHẨM BẢO VỆ SỨC KHỎE
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