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Good intentions may do bad things? Ventilator can't just "export"

Views:4     Author:Site Editor     Publish Time: 2020-04-02      Origin:Site

The international epidemic has intensified, and news of the distribution of anti-epidemic materials by some compatriots who have not returned home often appears on major social platforms. However, some friends reminded everyone on the video website: In foreign countries, when giving free masks to surrounding people, you must first protect yourself, especially to ensure that the product is "certified", otherwise you may bear legal responsibility.


Seeing this, are you very puzzled, "I give him a mask for free, this is sentiment. No matter the quality is good or bad, it is a heart, and I still have to bear legal responsibility?"

Take the United States as an example. The United States has a very complex legal system and industry product quality standards, as well as standards for the protection of consumer rights. According to US law, even if it is a donation, the third person will be liable for compensation due to product problems that cause injury or damage to the third person.

In fact, as the new coronavirus continues to ferment globally, many countries' medical systems are facing challenges. Due to the increasing number of diagnosed patients, there is a serious shortage of medical supplies such as ventilators. At present, the global medical supplies gap is large, and life-saving ventilators have fallen into a global shortage. As an important global producer of ventilators, China has become an important market for countries to snap up ventilators.

  China ’s official announcement states that from April 1st, enterprises exporting new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic statements when they declare to the customs that they are committed to export The Chinese medical device product registration certificate complies with the quality standards of the importing country (region).

Although many countries have recently relaxed the control of ventilators, such as the US FDA Emergency Use Authorization (EUA); the official or authorized institutions of EU member states can purchase protective products without the CE mark for medical personnel, but they cannot enter the regular sales channels Provide to other users, etc. But in the face of disaster, the life-saving ventilator must ensure quality!


In this special period, whether it is donation or sales, we must strictly control the quality and choose compliant products. If you want to export to other countries, you must first understand the requirements of local laws and regulations to prevent good things from becoming “bad things”.


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