KD TBSP CÓ CẦN LÀM BCD KHÔNG

KINH DOANH THIẾT BỊ SPA, THIẾT BỊ THẨM MỸ CÓ CẦN LÀM CÔNG BỐ ĐỦ ĐIỀU KIỆN MUA BÁN TBYT BCD KHÔNG?

Các mặt hàng thiết bị SPA, thiết bị thẩm mỹ khi bán ra thị trường, doanh nghiệp BẮT BUỘC phải làm CÔNG BỐ ĐỦ ĐIỀU KIỆN MUA BÁN TBYT LOẠI BCD gồm:

  • Thiết bị có chức năng “điều trị”, ví dụ như: Máy điều trị da bằng sóng siêu âm, Máy laser trị mụn sẹo, làm đẹp da, …
  • Thiết bị can thiệp, tác động vào cơ thể con người: Máy tiêm dưỡng chất, Máy phi kim, …
  • Hoặc đặc biệt như filler, chất làm đầy da cũng là TBYT loại D, khi nhập khẩu cần xin Đăng ký Lưu hành và khi mua bán tại VN cũng phải làm Công bố BCD.

=>> Thiết bị SPA, thiết bị thẩm mỹ cũng là THIẾT BỊ Y TẾ. Khi kinh doanh các mặt hành này tại Việt Nam BẮT BUỘC phải làm Công bố BCD.

LÀM CÔNG BỐ ĐỦ ĐIỀU KIỆN MUA BÁN TBYT BCD CHO DOANH NGHIỆP KINH DOANH THIẾT BỊ SPA, THẨM MỸ – LIÊN HỆ EM THÚY 0979785886

Như vậy, hồ sơ để làm Công bố đủ điều kiện mua bán TBYT loại BCD là gì?

1. Yêu cầu về nhân sự:

Có ít nhất 1 nhân viên kỹ thuật có trình độ cao đẳng chuyên ngành kỹ thuật, chuyên ngành y, dược, hóa học, sinh học hoặc cao đẳng kỹ thuật trang thiết bị y tế trở lên hoặc có trình độ cao đẳng trở lên mà chuyên ngành được đào tạo phù hợp với loại trang thiết bị y tế mà cơ sở kinh doanh.

2. Yêu cầu về kho:

Có kho bảo quản đáp ứng các điều kiện tối thiểu sau đây:

  • Có diện tích phù hợp với chủng loại và số lượng TBYT được bảo quản.
  • Đảm bảo thoáng, khô ráo, sạch sẽ, không gần các nguồn gây ô nhiễm.
  • Đáp ứng yêu cầu bảo quản khác của TBYT theo hướng dẫn sử dụng.

3. Yêu cầu về phương tiện vận tải:

Phương tiện vận chuyển trang thiết bị y tế từ cơ sở mua bán đến nơi giao hàng phù hợp với loại trang thiết bị y tế mà cơ sở mua bán.

=>> Để được hướng dẫn làm Công bố đủ điều kiện mua bán TBYT BCD, anh chị liên hệ EM THÚY 0979785886 hỗ trợ 24/7 ạ.

Hotline:0979785886 (zalo/tel) – Ms THÚY – Sales Manager
Mail: thuynt@airseaglobalgroup.com.vn
Add: P2414; 2412 Tòa Eurowindown, 27 Trần Duy Hưng, Cầu Giấy, Tp. Hà
Nội, Việt Nam

CAM KẾT HOÀN TIỀN 100% PHÍ DỊCH VỤ NẾU GIẤY PHÉP (CÔNG BỐ, LƯU HÀNH) KHÔNG CHUẨN VÀO THẦU, KHÔNG LẤY ĐƯỢC HÀNG

Airseaglobal Group hiện có hơn 4300 khách hàng thiết bị y tế, thông quan 15,000 tờ khai hải quan hàng y tế, xin giấy phép cho hơn 11.000 loại thiết bị y tế và phụ kiện

Xem full các số đăng ký lưu hành TBYT tiêu biểu Airseaglobal đã làm cho khách hàng (update liên tục) TẠI ĐÂY

Xem full các vận đơn hàng Sea tiêu biểu mà Airseaglobal đã làm cho khách hàng TẠI ĐÂY

Xem full các vận đơn hàng Air tiêu biểu mà Airseaglobal đã làm cho khách hàng TẠI ĐÂY

Ngoài ra, mời anh chị tham khảo các bộ GPNK/ Lưu hành mà Airseaglobal Group đã làm tại đây: https://thutucnhapkhauthietbiyte.com.vn/gioi-thieu/

EM THÚY HƯỚNG DẪN CHECK SOÁT HỒ SƠ ĐĂNG KÝ LƯU HÀNH TỪ CHI TIẾT VÀ HẠN CHẾ PHẢN HỒI ĐỐI VỚI TBYT LOẠI C, D

QUY TRÌNH CẤP SỐ ĐĂNG KÝ LƯU HÀNH C,D MỚI NHẤT

proflie

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