Dự kiến trong 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 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 thực tế đã và đang làm thành công hàng nghìn bộ hồ sơ Công bố, Lưu hành, AirseaGlobal nhận thấy 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.
Nhập khẩu máy đo loãng xương cần những thủ tục gì?
- HS CODE:
- Máy đo loãng xương có mã HS code: 9018.1200 / 9022.1400
- Thuế nhập khẩu 0%, VAT 5%
- PHÂN LOẠI: thuộc loại C
- THỦ TỤC HẢI QUAN:
- Bản phân loại
- Số đăng ký lưu hành cho TTBYT loại C (Bộ Y Tế cấp) (hiện có dự thảo lùi lưu hành đang chờ kí, nếu có hiệu lực thì các doanh nghiệp được dùng GPNK từ 2018 thì tiếp tục nhập khẩu bình thường cho tới hết năm 2023, sang đến năm 2024 bắt buộc phải có số đăng ký lưu hành mới nhập được, do vậy dự thảo lùi lưu hành chỉ là giải pháp tạm thời, các doanh nghiệp vẫn nên đăng kí lưu hành ngay từ bây giờ để chờ xét duyệt)
- Bộ hồ sơ đầy đủ: Invoice, Packing List, Catalogue, Tờ khai, C/O
- LƯU Ý
- 3M (Model, Manufacture, Made in) trên tem nhãn hàng thực tế phải chuẩn 100% như trên giấy tờ.
- Phải kê khai giá trước khi lưu hành hàng trên thị trường
CÁC BƯỚC ĐĂNG KÝ LƯU HÀNH MÁY ĐO ĐỘ LOÃNG XƯƠNG
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
- ISO 13485
- Bắt buộc phải là ISO 13485
- 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
- Chứng nhận lưu hành tự do (CFS)
- Được hợp thức hóa lãnh sự
- Ghi đầy đủ thông tin nhà sản xuất, tên sản phẩm, chủng loại
- Trên CFS phải ghi rõ “sản phẩm được lưu hành tại thị trường nội địa và không hạn chế xuất khẩu”
- Ủy quyền Authorization
- Làm theo mẫu do Bộ Y Tế ban hành
- Được hợp thức hóa lãnh sự
- Bảo hành hoặc xác nhận hàng dùng 1 lần
- Làm theo mẫu do bộ y tế ban hành
- Được hợp thức hóa lãnh sự
- Hướng dẫn sử dụng: yêu cầu có bản hướng dẫn sử dụng gốc của nhà sản xuất
- Tem nhãn hàng gốc: yêu cầu scan màu đầy đủ mẫu nhãn của từng chủng loại sản phẩm, từng quy cách đóng gói.
- 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
Liên hệ em để được hỗ trợ Phân loại chuẩn TT05(em có bản tổng hợp phân loại chuẩn hơn 300 mặt hàng, bác nào cần nhắn zalo em gửi ạ)
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, G
BƯỚC 5: NỘP LƯU HÀNH VÀ CHỜ PHẢN HỒI:
AIRSEAGLOBAL chuẩn hóa và hoàn thiện form mẫu, nộp hồ sơ.
AIRSEAGLOBAL – Chuyên thủ tục nhập khẩu Mỹ phẩm, Thực phẩm chức năng, Thiết bị y tế
 |
Tuyết Minh – AIRSEAGLOBAL GROUP SALES Zalo: 0971 460 378 Mobi: 0971 460 378 Email: minhntt@airseaglobalgroup.com.vn Add: Phòng 2412, 2414, tòa Eurowindow, 27 Trần Duy Hưng, Cầu Giấy, HN |
” 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
Web : https://airseaglobal.com.vn | http://airseaglobal.com.vn
Reg/ Bill Address : A9/4 , MO DIA CHAT GROUP, CO NHUE 2 WARD, BAC TU LIEM DIST, HA NOI.
Head office in Hanoi
Room 2412, Euro window Complex building, 27 Tran Duy Hung, Cau Giay, Ha Noi.
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Currently it sounds like WordPress is the best blogging platform out there right now. (from what I’ve read) Is that what you’re using on your blog?
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Right now it appears like Movable Type is the best blogging platform available right now. (from what I’ve read) Is that what you are using on your blog?
Right now it sounds like Drupal is the preferred blogging platform out there right now. (from what I’ve read) Is that what you’re using on your blog?
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Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my blog that automatically tweet my newest twitter updates. I’ve been looking for a plug-in like this for quite some time and was hoping maybe you would have some experience with something like this. Please let me know if you run into anything. I truly enjoy reading your blog and I look forward to your new updates.
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Aw, this was a very nice post. Finding the time and actual effort to produce a top notch article… but what can I say… I put things off a lot and don’t seem to get anything done.
Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my blog that automatically tweet my newest twitter updates. I’ve been looking for a plug-in like this for quite some time and was hoping maybe you would have some experience with something like this. Please let me know if you run into anything. I truly enjoy reading your blog and I look forward to your new updates.
Aw, this was a very nice post. Taking the time and actual effort to make a great article… but what can I say… I put things off a whole lot and don’t seem to get anything done.
Hi there, You have done an excellent job. I’ll definitely digg it and individually recommend to my friends. I am confident they will be benefited from this site.
Currently it looks like Drupal is the preferred blogging platform out there right now. (from what I’ve read) Is that what you’re using on your blog?
Hello there, You’ve done an incredible job. I’ll certainly digg it and in my view suggest to my friends. I’m sure they will be benefited from this website.
Currently it looks like BlogEngine is the best blogging platform available right now. (from what I’ve read) Is that what you’re using on your blog?
Aw, this was an exceptionally good post. Finding the time and actual effort to make a great article… but what can I say… I procrastinate a lot and never seem to get nearly anything done.
Can I simply say what a relief to find somebody who truly understands what they’re discussing on the net. You certainly realize how to bring an issue to light and make it important. More and more people really need to read this and understand this side of your story. I was surprised that you are not more popular because you most certainly possess the gift.
Can I just say what a relief to find someone that truly knows what they’re talking about on the net. You definitely know how to bring an issue to light and make it important. More people must check this out and understand this side of your story. It’s surprising you are not more popular since you most certainly have the gift.
Right now it seems like Expression Engine is the preferred blogging platform out there right now. (from what I’ve read) Is that what you are using on your blog?
Right now it appears like BlogEngine is the preferred blogging platform available right now. (from what I’ve read) Is that what you are using on your blog?
Hello there, You have performed a great job. I’ll definitely digg it and individually recommend to my friends. I’m sure they’ll be benefited from this website.
Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my blog that automatically tweet my newest twitter updates. I’ve been looking for a plug-in like this for quite some time and was hoping maybe you would have some experience with something like this. Please let me know if you run into anything. I truly enjoy reading your blog and I look forward to your new updates.
Aw, this was an exceptionally good post. Taking a few minutes and actual effort to create a great article… but what can I say… I hesitate a whole lot and don’t manage to get nearly anything done.
Aw, this was an incredibly good post. Spending some time and actual effort to make a great article… but what can I say… I put things off a whole lot and never seem to get nearly anything done.
Aw, this was an extremely good post. Finding the time and actual effort to make a great article… but what can I say… I hesitate a whole lot and never seem to get anything done.
Greate article. Keep posting such kind of info on your page. Im really impressed by it.