đăng ký lưu hành TBYT

DỊCH VỤ ĐĂNG KÝ LƯU HÀNH THIẾT BỊ Y TẾ LOẠI B,C,D – MS THẢO 0368874718

Em Thảo Katie 0368874718 (các bác alo trực tiếp hoặc add zalo sẽ có giá ưu đãi) – tư vấn, rà soát, chuẩn hóa hồ sơ đăng ký lưu hành TBYT từ A-Z – Tham khảo tất cả các bí kịp liên quan tới đăng ký lưu hành ở cuối bài viết. LUÔN UPDATE CÁC THÔNG TIN MỚI NHẤT LIÊN QUAN TỚI CẤP SỐ LƯU HÀNH TBYT, CHECK HỒ SƠ CHUẨN, CHÍNH XÁC ĐỐI VỚI CÁC MẶT HÀNG TBYT

Theo Nghị định số 98/2021/NĐ-CP của Chính phủ, Việc cấp số lưu hành cho Trang thiết bị Y tế loại B,C,D hàng nhập khẩu sẽ áp dụng từ 01/01/2022. Cụ thể: Loại A, B sẽ làm công bố ở Sở Y tế, loại C,D sẽ làm đăng ký lưu hành ở Vụ TTB.

Tuy nhiên, hiện tại, 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.

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.

“Các chuyên gia có tâm lý e ngại, lo sợ xảy ra các rủi ro thẩm định. Một số chuyên gia muốn rút không tham gia thẩm định, bên cạnh đó chuyên viên xử lý hồ sơ ở vụ trang thiết bị thì thiếu nên gây ra việc chậm cấp đăng ký lưu hành” – ông Lê Văn Dụng, Phó Vụ trưởng Vụ Trang thiết bị và công trình y tế, Bộ Y tế, lý giải.

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.

“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.

Đại diện của Bộ Y tế cho biết thêm, 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.

Quy trình xử lý lưu hành thiết bị y tế 2022

Airseaglobal xin gửi anh chị bộ hồ sơ xin cấp số lưu hành thiết bị y tế loại C,D (2022) như sau:

Hồ sơ đề nghị cấp mới số lưu hành đối với trang thiết bị y tế khác:

1. Văn bản đề nghị cấp mới số lưu hành.

2. CFS (hợp pháp hoá lãnh sự) đối với hàng NK hoặc công bố SX đối với hàng SX

3. ISO 13485

4. Uỷ quyền của chủ sở hữu trang thiết bị y tế cho cơ sở thực hiện việc đăng ký lưu hành (Hợp pháp hóa, theo mẫu)

5. Giấy xác nhận đủ điều kiện bảo hành do chủ sở hữu trang thiết bị y tế cấp, trừ trường hợp trang thiết bị y tế sử dụng một lần theo quy định của chủ sở hữu trang thiết bị y tế (hợp pháp hóa, theo mẫu)

6. Kết quả thẩm định hồ sơ CSDT của đơn vị do Bộ trưởng Bộ Y tế chỉ định kèm theo hồ sơ CSDT. ( áp dụng từ 2023)

7. Đối với trang thiết bị y tế chẩn đoán in vitro là thuốc thử, chất hiệu chuẩn, vật liệu kiểm soát phải có thêm giấy chứng nhận chất lượng do cơ quan có thẩm quyền của Việt Nam cấp.

8. Hồ sơ kỹ thuật chung về trang thiết bị y tế theo quy định của ASEAN (sau đây viết tắt là hồ sơ CSDT) sẽ áp dụng từ 01.01.2023. Trong 2022, mục này sẽ thay thế bằng các mục sau:

8.1. Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế bằng tiếng Việt, kèm theo tài liệu kỹ thuật mô tả chức năng, thông số kỹ thuật của trang thiết bị y tế do chủ sở hữu trang thiết bị y tế ban hành.(catalog) Riêng đối với thuốc thử, chất hiệu chuẩn, vật liệu kiểm soát in vitro: tài liệu kỹ thuật bằng tiếng Việt kèm theo tài liệu về nguyên vật liệu, về an toàn của sản phẩm, quy trình sản xuất và kiểm soát chất lượng sản phẩm, các báo cáo nghiên cứu lâm sàng và tiền lâm sàng bao gồm báo cáo độ ổn định.

8.2. Tài liệu hướng dẫn sử dụng của trang thiết bị y tế (tiếng anh + tiếng việt)

8.3. Mẫu nhãn sẽ sử dụng khi lưu hành tại Việt Nam của trang thiết bị y tế. (Nhãn gốc + nhãn phụ

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:

Ms Thu Thảo (Katie) –  Sales Manager

Mob: 0368.874.718 (zalo, viber)  | Skype: thaodtt99

AIRSEAGLOBAL GROUP – ” VUA DỊCH VỤ NHẬP KHẨU THIẾT BỊ Y TẾ”
” Cứ 10 Khách hàng xuất nhập khẩu thiết bị y tế trên thị trường thì có 4 bên làm gpnk, phân loại, Hải quan, vận chuyển Air/ Sea Exw, Fob với Airseaglobal Group “
“TOP 3 CHUYỂN PHÁT NHANH QUỐC TẾ LỚN NHẤT MIỀN BẮC”

WCA MEMBER ID : 73213 

Mail:thuthao@airseaglobalgroup.com.vn| thaodo.airseaglobal@gmail.com

Web : https://airseaglobal.com.vn | http://airseaglobal.com.vn  

Facebook Diễn đàn đăng ký lưu hành Thiết bị Y tế Việt Nam

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