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U.S. FDA to strengthen LED import regulation

  • Author:Abby
  • Source:Net
  • Release on :2017-04-19
  Recently, some media reports LED lights will be included in the scope of FDA regulation.
  It is understood that after the implementation of this rule, LED lamp products or will face a double level audit, in addition to customs clearance required by customs clearance, may also need FDA release. But this change is only related to the LED lamp itself, does not involve the use of LED lamp products (such as without the LED lamp itself).
  According to insiders, LED lights are incorporated into the FDA regulation scope, requirements for export logistics industry will be more stringent, the need in the customers receive the goods, clear manufacturers, reject not receive regular products.
  At the same time, in the provision of customs clearance materials, together with the need to provide LED lamp manufacturer information, including the manufacturer's name, address and contact telephone number, so as not to bring customs clearance delays. If you only use LED lights but do not have a LED lamp products, you need to clear the material clearly marked.
  According to industry insiders, this provision has just begun to implement, so in the next period of time should not be too strict checks.
  In 1968 the U.S. government issued the Radiation Control Health and Safety Act "control radiation, to ensure the health and safety law". The law is to protect the public from unnecessary radiation damage to electronic products.
  To this end, FDA has developed the relevant performance standards for electronic products, mandatory requirements for the United States to enter the U.S. market, radiation electronics must comply with the relevant performance standards.
  The radiation of the ultraviolet lamp lamp, lamp and high intensity mercury vapor discharge lamp must meet the requirements of FDA. The requirements of FDA for radiant lamps are mainly included in federal regulations 21 CFR part.
  The United States is responsible for the inspection and supervision of radiation products by the U.S. Food and Drug Administration (FDA). FDA requires foreign manufacturers of radioactive products to submit relevant materials to FDA before their products are sold to the United states. Then by the FDA to give a 7 digit number, equivalent to foreign manufacturers in the FDA registration number.
  In addition to the declaration of customs clearance of imported products in the import of radioactive products, it is necessary to declare to FDA by FDA 2877 form (electronic product declaration form). In addition to the relevant information of the manufacturer, importer, product and so on, the application form shall also require the registration number of the above-mentioned foreign production plant in FDA. Reporting information is incomplete or does not meet the requirements, are directly rejected by the FDA, even if the customs clearance is not allowed to enter the U.S. market sales.
  In addition to the reporting of information audit, sampling, inspection and FDA right before or after their entry into the market, in order to check the imported products actually meet the mandatory requirements of relevant laws and regulations on illegal products will be strictly dealt with FDA.
  FDA has two kinds: the punishment to detain, return and destroyed the illegal foreign products punishment, similar to medical devices, there are "automatic detention" system of illegal electronic products; and intends to illegal or false reports, and if the circumstances are serious, according to relevant laws and regulations, can be fined or sentenced or two both.