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Third party logistics of medical devices in Beijing opened for record on July 15

Third party logistics of medical devices in Beijing opened for record on July 15

  • Categories:行业动态
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  • Time of issue:2020-02-20
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(Summary description)The third party logistics enterprise of medical devices is an important participant in the operation and circulation of medical devices, but there is no perfect system for its supervision in China. Medical device GSP specification has made relevant provisions on the management of third-party logistics enterprises.

Third party logistics of medical devices in Beijing opened for record on July 15

(Summary description)The third party logistics enterprise of medical devices is an important participant in the operation and circulation of medical devices, but there is no perfect system for its supervision in China. Medical device GSP specification has made relevant provisions on the management of third-party logistics enterprises.

  • Categories:行业动态
  • Author:
  • Origin:
  • Time of issue:2020-02-20
  • Views:0
Information

 

北京医疗器械第三方物流7月15日开放备案

 

The third party logistics enterprise of medical devices is an important participant in the operation and circulation of medical devices, but there is no perfect system for its supervision in China. Medical device GSP specification has made relevant provisions on the management of third-party logistics enterprises. In order to implement the requirements of "medical device operation and management measures" and GSP specification, it is urgent to explore the third-party logistics distribution mode. Beijing has taken the lead and made great strides. On April 11, 2015, Beijing food and Drug Administration decided to start the evaluation of the third party logistics pilot project. The following is the full text of the notice:

On April 11, 2015, Beijing food and Drug Administration issued the notice on pilot evaluation and related work of third party logistics of medical devices. The contents of the notice are as follows:

Each district and County Bureau, each directly subordinate Branch Bureau, each medical device business enterprise:

In September 2013, our Bureau launched the third-party logistics pilot work in the circulation of medical devices. In the medical device business enterprises, the entrusted logistics of high-risk medical device products, such as orthopedic (dental) implants, cardiac (internal and surgical) implants, blood processing and artificial organs, disposable sterile consumables, in vitro diagnostic reagents, etc.

Since the pilot work has been carried out, medical device business enterprises have responded positively and applied actively. Through field investigation and comprehensive evaluation, a total of 10 enterprises in the city have obtained the pilot qualification and carried out work successively. The experimental results show that the third-party logistics mode of medical devices has a positive significance to promote the standardized and intensive management of storage and transportation of medical devices and meet the needs of industry development.

At the same time, it plays a positive role in improving the safety assurance level of medical device circulation process and improving the supervision efficiency of circulation link. The measures for the supervision and management of medical device operation, which was implemented in October 2014, has formally identified the provision of storage and distribution services by medical device business enterprises for other medical device production and operation enterprises as a business model, and has been included in the daily supervision of medical device circulation.

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