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LED lights will be included in the FDA regulatory scope, export or will face double

From:Shenzhen STS test services Co., Ltd. Hits:1357 Createtime:2017-04-03


      North America has been an important market for Chinese LED companies to export. The US market is the largest overseas market for Chinese companies, comparable to the whole of Europe. US imports of LED products in the country, China accounted for 70.50%, the amount of about 420 million US dollars, two-thirds of the US people have purchased household LED lighting products. January-February 2017, China's one-third of the LED bulb sold to the United States, is the largest proportion of all countries in the country.

      It is reported that since May 1, LED products need to do FDA certification (US Food and Drug Administration) to export. After the implementation of this rule, LED lights or will face a double "level" audit, which means that LED lights in addition to customs clearance in addition to the need, but also may need FDA release. It should be noted that this change only involves the LED light itself, does not involve the use of LED lights of the goods (such as without the LED lights themselves).
      According to industry insiders, LED lights are included in the scope of FDA supervision, the export logistics industry requirements will be more stringent, need to receive customer goods, find out the manufacturer, refused to receive irregular products.
      At the same time, in the provision of customs clearance materials, need to provide LED lights with the manufacturer information, including the manufacturer name, address and contact telephone, so as not to bring customs clearance delay.
      It is reported that if only the use of LED lights but not with the LED lights of the product, need to clearly clear in the clearance of materials clearly.
      According to the industry to reflect that this provision has just begun to implement, so in the next period of time should not be checked too strict.
Extended reading:
      "FDA" is the US Food and Drug Administration's English abbreviation, it is the international medical audit authority, authorized by the US Congress, the federal government, specializing in food and drug management of the highest law enforcement agencies. FDA is a supervisory body of government health control that is committed to the protection, promotion and improvement of national health by professionals such as doctors, lawyers, microbiologists, pharmacists, chemists and statisticians. FDA-certified foods, medicines, cosmetics and medical devices are safe and effective for the human body. Nearly 100 countries in the United States, only through the FDA approved drugs, equipment and technology in order to commercialize clinical applications.
      In 1968 the US government issued the Law on the Control of Radiation and Health and Safety. The law is to protect the public from unwanted electronic product radiation damage. To this end, the FDA has developed a performance standard for the radiation of electronic products, and the mandatory requirements for entering the US market for radiological electronic products must meet the relevant performance standards. Lamps with radiant solar lights, UV lamps and high-intensity mercury vapor discharge lamps must meet FDA requirements. FDA requirements for radiant lamps are mainly included in 21 CFR part 1040 of the US Federal Regulations.
      The United States is also responsible for the import inspection and management of radiological products by its US Food and Drug Administration (FDA). FDA requires foreign manufacturers of radiological products to submit their materials to the FDA before their products are sold to the United States. And then by the FDA to give a 7-digit number, the equivalent of foreign manufacturers in the FDA registration number.
      In addition to customs declaration, the importer must report to the FDA in the form of FDA 2877 (electronic product declaration form) when the import of radiation products is in customs clearance. In addition to the need to specify the production plant, importers, products and other relevant information, but also need the above-mentioned foreign production plant in the FDA registration number. Reporting incomplete or does not meet the requirements, are directly shut out by the FDA, even if the customs approval of the release can not enter the US market.
      In addition to reviewing the declared data, the FDA has the right to sample and inspect the product before or after it enters the market to check whether the imported product is in compliance with the mandatory requirements of US regulations and will be strictly addressed to the FDA.

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