ảnh web

TRỌN GÓI GIẤY TỜ CHO XƯỞNG SẢN XUẤT TẤM CHẮN GIỌT BẮN – HÀ MY 0949.755.806

Trước tình hình dịch bệnh diễn biến khó lường, kính chắn giọt bắn trở thành “vật bất ly thân” của tất cả mọi người khi ra ngoài. Đối với các đại lý sản xuất, kinh doanh thì đây là một sản phẩm tiềm năng, thu hút lượng mua đáng kể và đem lại lợi nhuận cao.

Để đủ điều kiện sản xuất, kinh doanh tấm chắn giọt bắn, các đơn vị sản xuất kinh doanh cần chuẩn bị những giấy tờ sau:

1. ISO 13485

Doanh nghiệp cần set up xưởng theo các tiêu chuẩn của hệ thống sản xuất trang thiết bị y tế, phù hợp với sản phẩm sản xuất là TẤM CHẮN GIỌT BẮN – Xây dựng quy trình sản xuất, đảm bảo quy trình kiểm soát chất lượng, danh mục các máy móc vật tư sử dụng đảm bảo…

2. Công bố đủ điều kiện sản xuất TTBYT

Nhân sự: Thời gian công tác có liên quan đến kỹ thuật trang thiết bị y tế từ đủ 24 tháng trở lên theo quy định và học ngành kỹ thuật dược, y, hoặc ngành liên quan đến mặt hàng các bác định kinh doanh

Trường hợp cơ sở không tự thực hiện kiểm tra chất lượng sản phẩm hoặc không có kho tàng hoặc không có phương tiện vận chuyển mà ký hợp đồng kiểm tra chất lượng, bảo quản, vận chuyển với cơ sở khác thì phải kèm theo các giấy tờ chứng minh cơ sở đó đủ điều kiện kiểm tra chất lượng, kho tàng, vận chuyển trang thiết bị y tế mà mình sản xuất.

3. Phân loại

Phân loại phải được thực hiện bởi bên có Chứng chỉ phân loại

4. Kiểm nghiệm: 

Doanh nghiệp cần chuẩn bị sẵn các tiêu chí kiểm nghiệm

5. Công bố A:

Làm tại sở y tế mà DN đăng kí kinh doanh. Khi làm công bố A doanh nghiệp lưu ý Tiêu chuẩn cơ sở và Bản kiểm nghiệm doanh nghiệp đã làm phải khớp nhau.

————————

Quý doanh nghiệp có thắc mắc về thủ tục làm giấy tờ sản xuất tấm chắn giọt bắn hoặc cần hỗ trợ thủ tục các nhóm hàng THIẾT BỊ Y TẾ có thể liên hệ:

Hà My: 0949.755.806 (zalo/tel)

Mail: mynh@airseaglobalgroup.com.vn

Airseaglobal – Thủ tục nhập khẩu thiết bị y tế chuyên nghiệp số 1 Việt Nam

Add: AIRSEAGLOBAL – Phòng 2414, tòa Eurowindow, 27 Trần Duy Hưng, Cầu Giấy, HN

Các dịch vụ cung cấp :

1. Phân loại TTBYT (CHỈ TỪ 400K, Có chứng chỉ hành nghề, chuẩn vào thầu, làm công bố, GPNK, lưu hành)

2. ISO 13485. ISO 9001. ISO 22000

3. Công bố đủ điều kiện sản xuất TTBYT

4. Công bố đủ điều kiện mua bán TTBYT loại BCD

5. Xin giấy phép nhập khẩu TBYT thông tư 30

6. Công bố TTBYT loại A nhập khẩu/sản xuất trong nước

7. Tra soát – Up sửa – Up mới hồ sơ đăng ký lưu hành TTBYT loại BCD nhập khẩu/sản xuất trong nước

8. Tư vấn thuế XNK, MÃ HS, xử lý VAT 5 VAT 10 hàng y tế

9. Công bố TPCN nhập khẩu/sx trong nước, đăng ký xác nhận nội dung quảng cáo

10. Tự công bố sản phẩm nhập khẩu

11. Công bố mỹ phẩm nhập khẩu

12. Thủ tục hải quan trọn gói

13. Vận chuyển AIR/SEA EXW, FOB, TRUCKING nội địa

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