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    New Export Regulations Have Been Issued Recently. China And The United States Both Have Important Changes.

    2020/5/14 23:11:00 0

    MaskExportNew RegulationChange

    In recent days, the news of masks and other epidemic prevention materials in the United States and the country has been constantly on the move, and many foreign trade people are in a turmoil. Today we are sorting out from the United States and China respectively.

    U.S.A

    Hotspot 1: CDC lists the latest 100+ Chinese mask business test results

    In May 12th, the US Centers for Disease Control and Prevention (CDC) issued a notice entitled "NPPTL Respirator Assessments to Support the COVID-19 Response" on the results of Chinese masks detection.

    The announcement listed 100+ China mask enterprises, including enterprise names, product types, implementation standards and test results. There are some problems, and exporters should be given special attention.

    The following is a partial screenshot of us CDC's test results for Chinese masks.

    Specific enquiry website:

    Https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

    Hot two: FDA bulk removal of non NIOSH certified masks

    In May 7th, the US FDA updated the EUA authorized documents for China's unlicensed NIOSH masks. Only 14 manufacturers of FDA approved non NIOSH certified masks were produced in China.

    Compared with the previously approved list of enterprises, the list of approved enterprises has not increased, and has been substantially reduced. The US FDA said the masks produced by the removed manufacturers could not provide enough protection against the new crown virus.

    According to the China Medical and health products import and Export Chamber of Commerce announced in May 1st, there were 45 non medical masks producing EUA access in the United States, which is in contradiction with the 14 Chinese mask enterprises issued by the US FDA in May 7th.

    That is to say, at least 31 non medical mask manufacturers are included in the Chinese export list, but they have been removed from the US FDA list by EUA.

    Is it possible for these enterprises to export to the US normally? It is suggested that the foreign party maintain close communication.

    The following is the list of Chinese standard Mask Companies for FDA emergency use authorization (EUA):

    Specific enquiry website:

    Https://www.fda.gov/media/136663/download

    domestic

    Hot spot 1: the General Administration of Customs announced the list of 16 enterprises that failed to export anti epidemic materials.

    In May 9th, the General Administration of Customs announced that the national customs has recently issued a checklist of unqualified batches of quality and safety of export anti epidemic materials, named 16 export enterprises and related production enterprises.

    16 unqualified enterprises inquired the website:

    Www.customs.gov.cn//customs/xwfb34/302425/3044771/index.html

    The General Administration said that in the special period of the global epidemic, in order to deepen international cooperation in the prevention and control of epidemic diseases and jointly cope with the global public health crisis, the customs authorities shall impose administrative sanctions on the epidemic prevention materials which are found to be mildew, damage, pollution, beyond the shelf life and the quality and safety of laboratories that have been detected in the export sector.

    In line with the standards of criminal cases, the transfer of judicial responsibilities to judicial organs will also take various disciplinary measures, such as lowering the credit rating, raising the proportion of inspection, stopping or cancelling the qualification qualification according to law, and exposing illegal information.

    Hot spot two: the 6 types of epidemic prevention materials such as masks in the country are exported and hot issues answered through the market purchasing trade mode.

    On the same day, the Yiwu Municipal Bureau of Commerce issued the circular on suspending market procurement for specific epidemic prevention materials.

    Specific enquiry website:

    Http://trade.yw.gov.cn/ptgg/t9698.html

    The announcement said that from May 10th onwards, the market will be suspended for export of new coronavirus test reagents, medical masks, medical protective clothing, respirators, infrared thermometers and other medical materials and non medical masks in the form of market purchase and trade.

    At the same time, the official micro issue of Yiwu City Commerce Bureau released "hot issues on export epidemic prevention materials".

    Hot topics include:

    1. can epidemic prevention materials be exported through market buying and trade?

    A: since May 10th, we have suspended the export of new coronavirus reagents, medical masks, medical protective clothing, respirators, infrared thermometers and other non medical masks (short for 5+1). Not all epidemic prevention materials can be exported through market buying and trade.

    2. can 5+1 epidemic prevention materials be exported to Yiwu?

    Answer: it can be exported in general trade in Yiwu (commonly known as "levy 3% retreat 3%" general trade can also be). Customs advisory telephone: Xinhai customs clearance total 13506890402.

    3., is it only the Ministry of Commerce's white list enterprises that export 5 categories of medical supplies and non medical masks?

    Answer: if 5 types of medical products are exported according to China's quality standard, they need to provide the certificate of registration of medical devices approved by the drug supervision and management department (the relevant information on the registration of medical devices and products in China is updated dynamically at the website of the State Administration of drug supervision and quarantine www.nmpa.gov.cn). If exported according to the foreign quality standard, the production enterprise should publish the list of enterprises in the list of production enterprises that have been certified or registered by the medical insurance association. Declaration of export medical supplies is required in the two case.

    If the non medical masks are exported according to Chinese quality standards, they should not be listed in the list of unqualified products and enterprises of the non medical masks investigated in the domestic market provided by the General Administration of market supervision (www.samr.gov.cn). If exported according to the foreign quality standard, the production enterprise should publish the list of enterprises in the list of production enterprises that have been certified or registered by the medical insurance association. In the two case, the electronic or written exporter and the importer jointly declare the products at the time of declaration, confirming that the products conform to Chinese quality standards or foreign quality standards, and the importers accept the quality standards of the purchased products and are not used for medical purposes.

    Hot spot three: what are the latest white list companies?

    In May 12th, the official website of the China Medical and health products import and Export Chamber of Commerce renewed the list of medical materials manufacturing enterprises that had obtained the foreign standard certification or registration, and the list of non medical mask manufacturers which obtained the certification or registration of foreign standards.

    List of medical materials production enterprises that have obtained standard certification or registration abroad

    Specific enquiry website:

    Www.cccmhpie.org.cn/Pub/6325/176237.shtml

    List of non medical mask manufacturers that have obtained standard certification or registration abroad

    Specific enquiry website:

    Www.cccmhpie.org.cn/Pub/6325/176233.shtml

    Hot spot four: regulation and upgrading

    In May 13th, the seven departments of the General Administration of Market Supervision issued the notice of the special rectification action plan for the quality and market order of the national epidemic prevention materials products. The circular pointed out that the five kinds of epidemic prevention materials and their important raw and auxiliary materials, such as masks, protective clothing, respirators, infrared thermometers (frontal thermometers), new coronavirus reagents, and so on, should be strengthened to ensure that the whole industrial chain of the epidemic prevention materials was stable. Function.

    Specific enquiry website:

    Gkml.samr.gov.cn/nsjg/jjjzj/202005/t20200513_315167.html

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