
Hơn 5.000 hồ sơ là số lượng mà các doanh nghiệp xin đăng ký cấp chứng nhận lưu hành trang thiết bị y tế tính từ đầu năm 2022. Thế nhưng, gần 9 tháng đã trôi qua, không có 1 hồ sơ nào được Bộ Y tế cấp chứng nhận.
Có hồ sơ hàng về cảng chờ thủ tục, có hồ sơ hàng bị phạt vì không thể thông quan, không ít doanh nghiệp rơi vào bế tắc vì chẳng còn giải pháp gì ngoài chờ đợi.
Em Thảo 0368874718 hỗ trợ làm Hồ sơ đăng ký lưu hành TBYT nhanh nhất, chuẩn nhất
Quy trình cấp lưu hành trang thiết bị y tế được Bộ Y tế thực hiện theo 4 bước (2022)
– Bước 1: 2 chuyên gia pháp chế thẩm định hồ sơ;
– Bước 2: Chuyên viên rà soát tổng hợp lại nội dung thẩm định;
– Bước 3: Trình Hội đồng tư vấn xem xét;
– Bước 4: Lãnh đạo Bộ ký duyệt và phát hành.
Theo lý giải của đại diện Bộ Y tế về việc chậm cấp lưu hành trang thiết bị y tế, nguyên nhân là từ bước đầu tiên về thẩm định hồ sơ.
“Trong thời gian tới sẽ đổi mới quy trình thẩm định hồ sơ theo hướng chuyển đổi vai trò của chuyên gia từ tiền kiểm sang hậu kiểm, giao trách nhiệm cho chuyên viên của Vụ tiền kiểm hồ sơ để đẩy nhanh tiến độ xử lý hồ sơ, cùng với đó là sửa đổi hoàn thiện các quy trình hướng dẫn tiêu chí thẩm định để đảm bảo sự thống nhất trong xử lý hồ sơ hạn chế sự e ngại của chuyên gia khi thẩm định hồ sơ” – ông Lê Văn Dụng cho biết.
Hiện có 18 chuyên gia thẩm định hồ sơ là cán bộ các đơn vị thuộc Bộ Y tế, mặc dù đã có quy định thời gian thẩm định hồ sơ nhưng thiếu rõ ràng về trách nhiệm của chuyên gia dẫn tới không thẩm định cũng không ai chịu trách nhiệm. Để khắc phục những bất cập hiện nay, đại diện Bộ Y tế cho biết sẽ thay đổi lại quy trình cấp giấy chứng nhận.
=> Dự kiến: 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.
Bài viết tham khảo nguồn VTV.VN
Em Thảo Katie 0368 874 718 – tư vấn, rà soát, chuẩn hóa hồ sơ đăng ký lưu hành TBYT từ A-Z
Bài viết tham khảo:
- Cấp nhanh số lưu hành TBYT: Xem tại đây
- Yêu cầu về hồ sơ đăng ký lưu hành TBYT: Xem tại đây
- 11 Lỗi sai (nâng cao- thực tế) khiến HS lưu hành ra chậm: Xem tai đây
- Đăng ký lưu hành chất làm đầy, bôi trơn khớp: Xem tại đây
- Các mẫu CFS chuẩn của BYT (phục vụ lưu hành và luồng cấp nhanh: Xem tại đây
- Danh mục TTBYT phải làm kiểm định an toàn và tính năng kỹ thuật: Xem tại đây
- QUY TRÌNH CẤP SỐ LƯU HÀNH THIẾT BỊ Y TẾ 2022: Xem tại đây
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Mob: 0368.874.718 (zalo, viber) | Skype: thaodtt99
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