Công văn 2968/BYT-TB-CT của Bộ Y tế về cấp phép nhập khẩu trang thiết bị y tế

Kính gửi: Công ty TNHH Trang thiết bị y tế và Tư vấn Môi trường Tâm Thy

Căn cứ Thông tư số 30/2015/TT-BYT ngày 12/10/2015 của Bộ Y tế quy định việc nhập khẩu trang thiết bị y tế.

Xét nội dung đề nghị tại công văn 150416/TTC ngày 15/4/2016 của đơn vị nhập khẩu về việc nhập khẩu trang thiết bị y tế. Bộ Y tế đã tổ chức họp thẩm định hồ sơ nhập khẩu và duyệt cấp giấy phép nhập khẩu các trang thiết bị y tế (mới 100%) theo danh mục như sau:

Đề nghị đơn vị nhập khẩu thực hiện đúng các quy định hiện hành về nhập khẩu trang thiết bị y tế. Về nhãn hàng hóa phải theo đúng quy định pháp luật về nhãn, đồng thời phải chịu trách nhiệm về số lượng, trị giá và chất lượng các trang thiết bị y tế nhập khẩu theo quy định của pháp luật.

Giấy phép nhập khẩu này có hiệu lực một (01) năm kể từ ngày ký ban hành.

DANH MỤC

(Kèm theo Công văn số: 2968/BYT-TB-CT ngày 20/5/2016 của Bộ Y tế)

I. Giá đỡ động mạch vành (stent) và vật tư tiêu hao đi kèm

1. Giá đỡ động mạch vành

1.1. Sirolimus Eluting Cobalt Chromium Coronary Stent ALEX

ZSTC2.00x0814CFS; ZSTC2.00x1014CFS; ZSTC2.00x1214CFS; ZSTC2.00x1514CFS; ZSTC2.00x1814CFS; ZSTC2.00x2214CFS;

ZSTC2.00x2514CFS; ZSTC2.00x2914CFS; ZSTC2.00x3414CFS; ZSTC2.00x3614CFS; ZSTC2.00x3814CFS; ZSTC2.00x4014CFS;

ZSTC2.25x0814CFS; ZSTC2.25x1014CFS; ZSTC2.25x1214CFS; ZSTC2.25x1514CFS; ZSTC2.25x1814CFS; ZSTC2.25x2214CFS;

ZSTC2.25x2514CFS; ZSTC2.25x2914CFS; ZSTC2.25x3414CFS; ZSTC2.25x3614CFS; ZSTC2.25x3814CFS; ZSTC2.25x4014CFS;

ZSTC2.50x0814CFS; ZSTC2.50x1014CFS; ZSTC2.50x1214CFS; ZSTC2.50x1514CFS; ZSTC2.50x1814CFS; ZSTC2.50x2214CFS;

ZSTC2.50x2514CFS; ZSTC2.50x2914CFS; ZSTC2.50x3414CFS; ZSTC2.50x3614CFS; ZSTC2.50x3814CFS; ZSTC2.50x4014CFS;

ZSTC2.75x0814CFS; ZSTC2.75x1014CFS; ZSTC2.75x1214CFS; ZSTC2.75x1514CFS; ZSTC2.75x1814CFS; ZSTC2.75x2214CFS;

ZSTC2.75x2514CFS; ZSTC2.75x2914CFS; ZSTC2.75x3414CFS; ZSTC2.75x3614CFS; ZSTC2.75x3814CFS; ZSTC2.75x4014CFS;

ZSTC3.00x0814CFS; ZSTC3.00x1014CFS; ZSTC3.00x1214CFS; ZSTC3.00x1514CFS; ZSTC3.00x1814CFS; ZSTC3.00x2214CFS;

ZSTC3.00x2514CFS; ZSTC3.00x2914CFS; ZSTC3.00x3414CFS; ZSTC3.00x3614CFS; ZSTC3.00x3814CFS; ZSTC3.00x4014CFS;

ZSTC3.25x0814CFS; ZSTC3.25x1014CFS; ZSTC3.25x1214CFS; ZSTC3.25x1514CFS; ZSTC3.25x1814CFS; ZSTC3.25x2214CFS;

ZSTC3.25x2514CFS; ZSTC3.25x2914CFS; ZSTC3.25x3414CFS; ZSTC3.25x3614CFS; ZSTC3.25x3814CFS; ZSTC3.25x4014CFS;

ZSTC3.50x0814CFS; ZSTC3.50x1014CFS; ZSTC3.50x1214CFS; ZSTC3.50x1514CFS; ZSTC3.50x1814CFS; ZSTC3.50x2214CFS;

ZSTC3.50x2514CFS; ZSTC3.50x2914CFS; ZSTC3.50x3414CFS; ZSTC3.50x3614CFS; ZSTC3.50x3814CFS; ZSTC3.50x4014CFS;

ZSTC3.75x0814CFS; ZSTC3.75x1014CFS; ZSTC3.75x1214CFS; ZSTC3.75x1514CFS; ZSTC3.75x1814CFS; ZSTC3.75x2214CFS;

ZSTC3.75x2514CFS; ZSTC3.75x2914CFS; ZSTC3.75x3414CFS; ZSTC3.75x3614CFS; ZSTC3.75x3814CFS; ZSTC3.75x4014CFS;

ZSTC4.00x0814CFS; ZSTC4.00x1014CFS; ZSTC4.00x1214CFS; ZSTC4.00x1514CFS; ZSTC4.00x1814CFS; ZSTC4.00x2214CFS;

ZSTC4.00x2514CFS; ZSTC4.00x2914CFS; ZSTC4.00x3414CFS; ZSTC4.00x3614CFS; ZSTC4.00x3814CFS; ZSTC4.00x4014CFS;

ZSTC4.50x0814CFS; ZSTC4.50x1014CFS; ZSTC4.50x1214CFS; ZSTC4.50x1514CFS; ZSTC4.50x1814CFS; ZSTC4.50x2214CFS;

ZSTC4.50x2514CFS; ZSTC4.50x2914CFS; ZSTC4.50x3414CFS; ZSTC4.50x3614CFS; ZSTC4.50x3814CFS; ZSTC4.50x4014CFS;

ZSTC5.00x0814CFS; ZSTC5.00x1014CFS; ZSTC5.00x1214CFS; ZSTC5.00x1514CFS; ZSTC5.00x1814CFS; ZSTC5.00x2214CFS;

ZSTC5.00x2514CFS; ZSTC5.00x2914CFS; ZSTC5.00x3414CFS; ZSTC5.00x3614CFS; ZSTC5.00x3814CFS; ZSTC5.00x4014CFS.

1.2. Cobalt choromium sirolimus eluting coronary stent ALEX PLUS

ZSTC2.00x0814CFSP; ZSTC2.00x1014CFSP; ZSTC2.00x1214CFSP; ZSTC2.00x1514CFSP; ZSTC2.00x1814CFSP; ZSTC2.00.X2214CFSP;

ZSTC2.00x2514CFSP; ZSTC2.00x2914CFSP; ZSTC2.00x3414CFSP; ZSTC2.00x3614CFSP; ZSTC200x3814CFSP; ZSTC2.00x4014CFSP;

ZSTC2.25x0814CFSP; ZSTC2.25x1014CFSP; ZSTC2.25x1214CFSP; ZSTC2.25x1514CFSP; ZSTC2.25x1814CFSP; ZSTC2.25x2214CFSP;

ZSTC2.25x2514CFSP; ZSTC2.25x2914CFSP; ZSTC2.25x3414CFSP; ZSTC2.25x3614CFSP; ZSTC225x3814CFSP; ZSTC2.25x4014CFSP;

ZSTC2.50x0814CFSP; ZSTC2.50x1014CFSP; ZSTC2.50x1214CFSP; ZSTC2.50x1514CFSP; ZSTC2.50x1814CFSP; ZSTC2.50x2214CFSP;

ZSTC2.50x2514CFSP; ZSTC2.50x2914CFSP; ZSTC2.50x3414CFSP; ZSTC2.50x3614CFSP; ZSTC2.50x3814CFSP; ZSTC2.50x4014CFSP;

ZSTC2.75x0814CFSP; ZSTC2.75x1014CFSP; ZSTC2.75x1214CFSP; ZSTC2.75x1514CFSP; ZSTC2.75x1814CFSP; ZSTC2.75x2214CFSP;

ZSTC2.75x2514CFSP; ZSTC2.75x2914CFSP; ZSTC2.75x3414CFSP; ZSTC2.75x3614CFSP; ZSTC2.75x3814CFSP; ZSTC2.75x4014CFSP;

ZSTC3.00x0814CFSP; ZSTC3.00x1014CFSP; ZSTC3.00x1214CFSP; ZSTC3.00x1514CFSP; ZSTC3.00x1814CFSP; ZSTC3.00x2214CFSP;

ZSTC3.00x2514CFSP; ZSTC3.00x2914CFSP; ZSTC3.00x3414CFSP; ZSTC3.00x3614CFSP; ZSTC3.00x3814CFSP; ZSTC3.00x4014CFSP;

ZSTC3.25x0814CFSP; ZSTC3.25x1014CFSP; ZSTC3.25x1214CFSP; ZSTC3.25x1514CFSP; ZSTC3.25x1814CFSP; ZSTC3.25x2214CFSP;

ZSTC3.25x2514CFSP; ZSTC3.25x2914CFSP; ZSTC3.25x3414CFSP; ZSTC3.25x3614CFSP; ZSTC325x3814CFSP; ZSTC3.25x4014CFSP;

ZSTC3.50x0814CFSP; ZSTC3.50x1014CFSP; ZSTC3.50x1214CFSP; ZSTC3.50x1514CFSP; ZSTC3.50x1814CFSP; ZSTC3.50x2214CFSP;

ZSTC3.50x2514CFSP; ZSTC3.50x2914CFSP; ZSTC3.50x3414CFSP; ZSTC3.50x3614CFSP; ZSTC3.50x3814CFSP; ZSTC3.50x4014CFSP;

ZSTC3.75x0814CFSP; ZSTC3.75x1014CFSP; ZSTC3.75x1214CFSP; ZSTC3.75x1514CFSP; ZSTC3.75x1814CFSP; ZSTC3.75x2214CFSP;

ZSTC3.75x2514CFSP; ZSTC3.75x2914CFSP; ZSTC3.75x3414CFSP; ZSTC3.75x3614CFSP; ZSTC3.75x3814CFSP; ZSTC3.75x4014CFSP;

ZSTC4 00x0814CFSP; ZSTC4.00x1014CFSP; ZSTC4.00x1214CFSP; ZSTC4.00x1514CFSP; ZSTC4.00x1814CFSP; ZSTC4.00x2214CFSP;

ZSTC4.00x2514CFSP; ZSTC4.00x2914CFSP; ZSTC4.00x3414CFSP; ZSTC4.00x3614CFSP; ZSTC4.00x3814CFSP; ZSTC4.00x4014CFSP;

ZSTC4.50x0814CFSP; ZSTC4.50x1014CFSP; ZSTC4.50x1214CFSP; ZSTC4.50x1514CFSP; ZSTC4.50x1814CFSP; ZSTC4.50x2214CFSP;

ZSTC4.50x2514CFSP; ZSTC4.50x2914CFSP; ZSTC4.50x3414CFSP; ZSTC4.50x3614CFSP; ZSTC4.50x3814CFSP; ZSTC4.50x4014CFSP;

ZSTC5.00x0814CPSP; ZSTC5.00x1014CFSP; ZSTC5.00x1214CFSP; ZSTC5.00x1514CFSP; ZSTC5.00x1814CFSP; ZSTC5.00x2214CFSP;

ZSTC5.00x2514CFSP; ZSTC5.00x2914CFSP; ZSTC5.00x3414CFSP; ZSTC4.00x3614CFSP; ZSTC4.00x3814CFSP; ZSTC4.00x4014CFSP.

1.3. Sirolimus Eluting Cobalt Chromium Coronary Stent BIOSS LIM

ZSTB2.50x3.25x1514S; ZSTB2.75x3.50x1514S; ZSTB3.00x3.50x1514S;

ZSTB3.00x3.75x1514S; ZSTB3.50x4.25x1514S; ZSTB3.75x4.50x1514S

ZSTB2.50x3.25x1814S; ZSTB2.75x3.50x1814S; ZSTB3.00x3.50x1814S

ZSTB3.00x3.75x1814S; ZSTB3.50x4.25x1814S; ZSTB3.75x4.50x1814S

ZSTB2.50x3.25x2314S; ZSTB2.75x3.50x2314S; ZSTB3.00x3.50x2314S

ZSTB3.00x3.75x2314S; ZSTB3.50x4.25x2314S; ZSTB3.75x4.50x2314S

1.4. Cobalt Chromium Coronary Stent Coflexus

ZSTC2.00x0814CF; ZSTC2.00x1014CF; ZSTC2.00x1214CF; ZSTC2.00x1514CF; ZSTC2.00x1814CF; ZSTC2.00x2214CF;

ZSTC2.00x2514CF; ZSTC2.00x2914CF; ZSTC2.00x3414CF; ZSTC2.00x3614CF; ZSTC2.00x3814CF; ZSTC2.00x4014CF;

ZSTC2.25x0814CF; ZSTC2.25x1014CF; ZSTC2.25x1214CF; ZSTC2.25x1514CF; ZSTC2.25x1814CF; ZSTC2.25x2214CF;

ZSTC2.25x2514CF; ZSTC2.25x2914CF; ZSTC2.25x3414CF; ZSTC2.25x3614CF; ZSTC2.25x3814CF; ZSTC2.25x4014CF;

ZSTC2.50x0814CF; ZSTC2.50x1014CF; ZSTC2.50x1214CF; ZSTC2.50x1514CF; ZSTC2.50x1814CF; ZSTC2.50x2214CF;

ZSTC2.50x2514CF; ZSTC2.50x2914CF; ZSTC2.50x3414CF; ZSTC2.50x3614CF; ZSTC2.50x3814CF; ZSTC2.50x4014CF;

ZSTC2.75x0814CF; ZSTC2.75x1014CF; ZSTC2.75x1214CF; ZSTC2.75x1514CF; ZSTC2.75x1814CF; ZSTC2.75x2214CF;

ZSTC2.75x2514CF; ZSTC2.75x2914CF; ZSTC2.75x3414CF; ZSTC2.75x3614CF; ZSTC2.75x3814CF; ZSTC2.75x4014CF;

ZSTC3.00x0814CF; ZSTC3.00x1014CF; ZSTC3.00x1214CF; ZSTC3.00x1514CF; ZSTC3.00x1814CF; ZSTC3.00x2214CF;

ZSTC3.00x2514CF; ZSTC3.00x2914CF; ZSTC3.00x3414CF; ZSTC3.00x3614CF; ZSTC3.00x3814CF; ZSTC3.00x4014CF;

ZSTC3.25x0814CF; ZSTC3.25x1014CF; ZSTC3.25x1214CF; ZCTC3.25x1514CF; ZSTC3.25x1814CF; ZSTC3.25x2214CF;

ZSTC3.25x2514CF; ZSTC3.25x2914CF; ZSTC3.25x3414CF; ZSTC3.25x3614CF; ZSTC3.25x3814CF; ZSTC3.25x4014CF;

ZSTC3.50x0814CF; ZSTC3.50x1014CF; ZSTC3.50x1214CF; ZSTC3.50x1514CF; ZSTC3.50x1814CF; ZSTC3.50x2214CF;

ZSTC3.50x2514CF; ZSTC3.50x2914CF; ZSTC3.50x3414CF; ZSTC3.50x3614CF; ZSTC3.50x3814CF; ZSTC3.50x4014CF;

ZSTC3.75x0814CF; ZSTC3.75x1014CF; ZSTC3.75x1214CF; ZSTC3.75x1514CF; ZSTC3.75x1814CF; ZSTC3.75x2214CF;

ZSTC3.75x2514CF; ZSTC3.75x2914CF; ZSTC3.75x3414CF; ZSTC3.75x3614CF; ZSTC3.75x3814CF; ZSTC3.75x4014CF;

ZSTC4.00x0814CF; ZSTC4.00x1014CF; ZSTC4.00x1214CF; ZSTC4.00x1514CF; ZSTC4.00x1814CF; ZSTC4.00x2214CF;

ZSTC4.00x2514CF; ZSTC4.00x2914CF; ZSTC4.00x3414CF; ZSTC4.00x3614CF; ZSTC4.00x3814CF; ZSTC4.00x4014CF;

ZSTC4.50x0814CF; ZSTC4.50x1014CF; ZSTC4.50x1214CF; ZSTC4.50x1514CF; ZSTC4.50x1814CF; ZSTC4.50x2214CF;

ZSTC4.50x2514CF; ZSTC4.50x2914CF; ZSTC4.50x3414CF; ZSTC4.50x3614CF; ZSTC4.50x3814CF; ZSTC4.50x4014CF;

ZSTC5.00x0814CF; ZSTC5.00x1014CF; ZSTC5.00x1214CF; ZSTC5.00x1514CF; ZSTC5.00x1814CF; ZSTC5.00x2214CF;

ZSTC5.00x2514CF; ZSTC5.00x2914CF; ZSTC5.00x3414CF; ZSTC5.00x3614CF; ZSTC5.00x3814CF; ZSTC5.00x4014CF;

Vật tư tiêu hao đi kèm: Delivery System;

II. Bóng nong mạch vành và vật tư tiêu hao đi kèm

1. Coronay Angioplasty Catheters River

CBR1.25x10140; CBR1.25x15140; CBR1.25x20140; CBR1.25x25140; CBR 1.25x30140; CBR1.25x35140; CBR1.25x40140; CBR1.5x10140;

CBR1.5x15140; CBR1.5x20140; CBR1.5x25140; CBR1.5x30140; CBR1.5x35140; CBR1.5x40140; CBR1.75x10140; CBR1.75x15140;

CBR1.75x20140; CBR1.75x25140; CBR1.75x30140; CBR1.75x35140; CBR1.75x40140; CBR2.0x10140; CBR2.0x15140; CBR2.0x20140;

CBR2.0x25140; CBR2.0x30140; CBR2.0x35140; CBR2.0x40140; CBR2.25x10140; CBR2.25x15140; CBR2.25x20140; CBR2.25x25140;

CBR2.25x30140; CBR2.25x35140; CBR2.25x40140; CBR2.5x10140; CBR2.5x15140; CBR2.5x20140; CBR2.5x25140; CBR2.5x30140;

CBR2.5x35140; CBR2.5x40140; CBR2.75x10140; CBR2.75x15140; CBR2.75x20140; CBR2.75x25140; CBR2.75x30140; CBR2.75x35140;

CBR2.75x40140; CBR3.0x10140; CBR3.0x15140; CBR3.0x20140; CBR3.0x25140; CBR3.0x30140; CBR3.0x35140; CBR3.0x40140;

CBR3.25x10140; CBR3.25x15140; CBR3.25x20140; CBR3.25x25140; CBR3.25x30140; CBR3.25x35140; CBR3.25x40140; CBR3.5x10140;

CBR3.5x15140; CBR3.5x20140; CBR3.5x25140; CBR3.5x30140; CBR3.5x35140; CBR3.5x40140; CBR3.75x10140; CBR3.75x15140;

CBR3.75x20140; CBR3.75x25140; CBR3.75x30140; CBR3.75x35140; CBR3.75x40140; CBR4.0x10140; CBR4.0x15140; CBR4.0x20140;

CBR4.0x25140; CBR4.0x30140; CBR4.0x35140; CBR4.0x40140.

2. Coronay Angioplasty Catheters BOTTLE

CBB2.50x2.75x10140; CBB2.50x3.25x10140; CBB2.75x3.00x10140; CBB2.75x3.50x10140; CBB3.00x3.50x10140; CBB3.00x3.75x10140;

CBB3.50x4.25x10140; CBB3.75x4.50x10140; CBB2.50x2.75x15140; CBB2.50x3.25x15140; CBB2.75x3.00x15140; CBB2.75x3.50x15140;

CBB3.00x3.50x15140; CBB3.00x3.75x15140; CBB3.50x4.25x15140; CBB3.75x4.50x15140; CBB2.50x2.75x18140; CBB2.50x3.25x18140;

CBB2.75x3.00x18140; CBB2.75x3.50x18140; CBB3.00x3.50x18140; CBB3.00x3.75x18140; CBB3.50x4.25x18140; CBB3.75x4.50x18140;

CBB2.50x2.75x23140; CBB2.50x3.25x23140; CBB2.75x3.00x23140; CBB2.75x3.50x23140; CBB3.00x3.50x23140; CBB3.00x3.75x23140;

CBB3.50x4.25x23140; CBB3.75x4.50x23140

III. Giá đỡ động mạch thận - Stent for Renal Vesels Nefro

ZSTN5x814140; ZSTN5x1014140, ZSTN5x1214140; ZSTN5x1414140; ZSTN5x1614140; ZSTN5x1814140; ZSTN5x2014140;

ZSTN5x2214140; ZSTN5x2514140; ZSTN6x814140; ZSTN6x1014140; ZSTN6x1214140; ZSTN6x1414140; ZSTN6x1614140;

ZSTN6x1814140; ZSTN6x2014140; ZSTN6x2214140; ZSTN6x2514140; ZSTN7x814140; ZSTN7x1014140; ZSTN7x1214140;

ZSTN7x1414140; ZSTN7x1614140; ZSTN7x1814140; ZSTN7x2014140; ZSTN7x2214140; Z5TN7x2514140;

IV. Bóng nong van động mạch phổi (Valvuloplasty Catheter) và dụng cụ tiêu hao đi kèm

1. Bóng nong van động mạch phổi: Valvuloplasty Catheter

VALP5x2570; VALP5x3070; VALP5x4070; VALP5x4570; VALP5x5070; VALP5x6070;

VALP6x2070; VALP6x2570; VALP6x3070; VALP6x4070; VALP6x4570; VALP6x5070; VALP6x6070; VALP7x2070; VALP7x2570;

VALP7x3070; VALP7x4070; VALP7x4570; VALP7x5070; VALP7x6070; VALP8x2070; VALP8x2570; VALP8x3070; VALP8x4070;

VALP8x4570; VALP8x5070; VALP8x6070; VALP9x2070; VALP9x2570; VALP9x3070; VALP9x4070; VALP9x4570; VALP9x5070;

VALP9x6070; VALP10x2070; VALP10x2570; VALP10x3070; VALP10x4070; VALP10x4570; VALP10x5070; VALP10x6070;

VALP11x2070; VALP11x2570; VALP11x3070; VALP11x4070; VALP11x4570; VALP11x5070; VALP11x6070; VALP12x2070;

VALP12x2570; VALP12x3070; VALP12x4070; VALP12x4570; VALP12x5070; VALP12x6070; VALP13x2070; VALP13x2570;

VALP13x3070; VALP13x4070; VALP13x4570; VALP13x5070; VALP13x6070; VALP14x2070; VALP14x2570; VALP14x3070;

VALP14x4070; VALP14x4570; VALP14x5070; VALP14x6070; VALP15x2070; VALP15x2570; VALP15x3070; VALP15x4070;

VALP15x4570; VALP15x5070; VALP15x6070; VALP15x20110; ALP15x25110; VALP15x30110; VALP15x40110; VALP15x45110;

VALP15x50110; VALP15x60110; VAL16x20110; VAL16x25110; VAL16x30110; VAL16x40110; VAL16x45110; VAL16x50110;

VAL16x60110; VAL18x20110; VAL18x25110; VAL18x30110; VAL18x40110; VAL18x45110; VAL18x50110; VAL18x60110;

VAL20x20110; VAL20x25110; VAL20x30110; VAL20x40110; VAL20x45110; VAL20x50110; VAL23x20110; VAL23x25110;

VAL23x30110; VAL23x40110; VAL23x45110; VAL23x50110; VAL23x60110; VAL25x20110; VAL25x25110; VAL25x30110;

VAL25x40110; VAL25x45110; VAL25x50110; VAL25x60110; VAL28x20110; VAL28x25110; VAL28x30110; VAL28x40110;

VAL28x45110; VAL28x50110; VAL28x60110; VAL30x20110; VAL30x25110; VAL30x30110; VAL30x40110; VAL30x45110;

VAL30x50110; VAL30x60110; VAL35x20110; VAL35x25110; VAL35x30110; VAL35x40110; VAL35x45110; VAL35x50110;

VAL35x60110; VAL40x20110; VAL40x25110; VAL40x30110; VAL40x40110; VAL40x45110; VAL40x50110; VAL40x60110;

2. Bộ dụng cụ tiêu hao: Dây dẫn, ống thông