KHÁNH HUYỀN

CHÍNH THỨC GIA HẠN GIẤY PHÉP NHẬP KHẨU ĐẾN HẾT NĂM 2024

AIRSEAGLOBAL GROUP

TIN MỚI: CHÍNH THỨC KÝ NGHỊ ĐỊNH 07/2023/NĐ-CP SỬA ĐỔI BỔ SUNG NGHỊ ĐỊNH 98/2021/NĐ-CP VỀ QUẢN LÝ TRANG THIẾT BỊ Y TẾ

Ngày 03/03, Bộ Y tế ban hành Nghị định 07/2023/NĐ-CP sửa đổi bổ sung Nghị định 98/2021/NĐ-CP.

Link tải, FULL Nghị định 07/2023/NĐ-CP

Điểm mới quan trọng:

1. Giấy phép nhập khẩu TTBYT đã được cấp từ ngày 1/1/2018 đến 31/12/2021 được tiếp tục sử dụng đến hết ngày 31/12/2024

2. Số đăng ký lưu hành đối với TTBYT là sinh phẩm chẩn đoán in vitro đã được cấp từ ngày 1/1/2014 đến ngày 31/12/2019 được tiếp tục sử dụng đến hết ngày 31/12/2024

3. Đối với trang thiết bị y tế không thuộc danh mục phải cấp giấy phép nhập khẩu (trừ hóa chất, chế phẩm diệt côn trùng, diệt khuẩn dùng trong lĩnh vực gia dụng và y tế chỉ có một mục đích là khử khuẩn trang thiết bị y tế) và đã có bản phân loại là trang thiết bị y tế thuộc loại C, D được Bộ Y tế công bố thông tin trên cổng thông tin điện tử được tiếp tục nhập khẩu đến hết ngày 31 tháng 12 năm 2024 theo nhu cầu, không hạn chế số lượng, không cần văn bản của Bộ Y tế xác nhận là trang thiết bị y tế và không phụ thuộc vào thời gian công bố thông tin trên Cổng thông tin điện tử của Bộ Y tế khi thực hiện thông quan.

4. Bổ sung Điều 39a về việc xử lý thiết bị y tế sau khi thu hồi số lưu hành

5. Hồ sơ CSDT bắt buộc áp dụng từ ngày 01/01/2024

6. Số lần phản hồi hồ sơ lưu hành: 03 lần, quá 03 lần phản hồi phải làm mới hồ sơ

7. Chỉ thực hiện kê khai giá đối với TTBYT khi có biến động bất thường về giá ảnh hưởng đến nguồn cung cấp TTBYT, khả năng chi trả của người mua, khả năng thanh toán của Quỹ bảo hiểm y tế.

8. Nghị định số 07/2023/NĐ-CP cũng quy ban hành các quy định để giải quyết vướng mắc trong việc xử lý TTBYT khi bị thu hồi số đăng ký lưu hành vì vậy có thể gây khó khăn cho các doanh nghiệp, người dân, cơ quan quản lý nhà nước trong việc thực hiện, xử lý TTBYT có số đăng ký lưu hành đã bị thu hồi.

9. Nghị định số 07/2023/NĐ-CP sửa đổi, bổ sung Điều 46, Điều 48 Nghị định số 98/2021/NĐ-CP theo hướng: Việc nhập khẩu TTBYT đã qua sử dụng thực hiện theo quy định của pháp luật về quản lý ngoại thương; Bộ Y tế không cấp giấy phép nhập khẩu TTBYT đã qua sử dụng.

10. Đối với các bộ GPNK đã nộp trước 2022 mà chưa được cấp có 2 hướng:

?1 là BYT sẽ cấp tiếp gpnk (nhưng xin giấy tờ theo lưu hành) và thời hạn gpnk tới hết 2024, sau này vẫn phải làm lưu hành

? 2 là sẽ xin luôn số lưu hành, BYT sẽ ưu tiên xử lý trước.

Link tải, FULL Nghị định 07/2023/NĐ-CP

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3.099 comments

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    Ключевым типом в этой системе является Генератор. Генераторы отличаются высокой энергетичностью и способностью легко и эффективно завершать начатые задачи. Главная задача Генератора — найти деятельность, которая приносит радость и удовлетворение. Генератор начинает действовать, когда ощущает внутренний отклик. Их индивидуальная особенность заключается в том, что энергия накапливается, только когда они следуют своему отклику.

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