{"id":9074,"date":"2026-04-14T17:30:14","date_gmt":"2026-04-14T09:30:14","guid":{"rendered":"https:\/\/www.qicaiying.cn\/?p=9074"},"modified":"2026-04-14T17:30:16","modified_gmt":"2026-04-14T09:30:16","slug":"%e7%b4%a7%e6%80%a5%e9%80%9a%e7%9f%a5%ef%bc%81%e4%ba%9a%e9%a9%ac%e9%80%8a4%e6%9c%8816%e5%bc%80%e5%a7%8b%e5%bc%ba%e5%88%b6%e5%ae%a1%e6%a0%b8%ef%bc%8c%e8%bf%993%e7%b1%bb%e5%8d%96%e5%ae%b6%e4%b8%8d","status":"publish","type":"post","link":"https:\/\/www.qicaiying.cn\/en\/archives\/9074","title":{"rendered":"Urgent Notice! Amazon starts mandatory audits on April 16, these 3 types of sellers will be taken down if they don't read it"},"content":{"rendered":"

Sellers involved in the three major categories of safety alerts, over-the-counter medications, and medical devices, if you have not completed a compliance audit, your items will beDirectly off the shelves<\/strong>and even faceAccounts restricted<\/strong>The<\/p>\n\n\n\n

It's not a warning, it'sultimatum<\/strong>The<\/p>\n\n\n\n

If you sell smoke alarms, blood pressure monitors, band-aids, contact lens care solution ...... this is a must read.<\/p>\n\n\n\n

01 What exactly is going to be implemented on April 16th?<\/h2>\n\n\n\n

Amazon official notice: since April 16, 2026, the following categories in the three major sites in the United States, Canada and Europe, will be mandatory access rules (Gating Requirements):<\/p>\n\n\n\n

Affected categories<\/th>Examples of specific products<\/th>compliance requirement<\/th><\/tr><\/thead>
security alert<\/td>Smoke alarms, carbon monoxide detectors, home fire extinguishers<\/td>Security Certification + Statement of Compliance<\/td><\/tr>
Over-the-counter (OTC)<\/td>Painkillers, cold medicine, band-aids, vitamin supplements<\/td>FDA\/CE Registration + Labeling Compliance<\/td><\/tr>
medical equipment<\/td>Sphygmomanometer, blood glucose meter, thermometer, contact lens care solution<\/td>Medical Device Registration + Quality System Certification<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Core changes:<\/p>\n\n\n\n

Before:<\/strong>These categories can be shelved normally, and the compliance document is \u201drecommended to provide\u201d<\/p>\n\n\n\n

From April 16th:<\/strong>You must pass the Amazon compliance audit in advance, otherwise the product is taken down and your account is restricted<\/p>\n\n\n\n

02 Which sellers will be affected?<\/h2>\n\n\n\n

Category 1: Selling security alarm equipment<\/h3>\n\n\n\n
offerings<\/th>Affected or not<\/th><\/tr><\/thead>
smoke alarm<\/td>\u2705 Affected<\/td><\/tr>
Carbon Monoxide Detector<\/td>\u2705 Affected<\/td><\/tr>
Domestic fire extinguishers<\/td>\u2705 Affected<\/td><\/tr>
Gas Leakage Alarm<\/td>\u2705 Affected<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n

Pothole stepping is common:<\/strong> Many sellers think that \u201dsmall appliances with batteries\u201d do not belong to the security equipment, but Amazon puts smoke alarms and CO detectors in the security alarm category.<\/p>\n<\/blockquote>\n\n\n\n

Category 2: Selling over-the-counter drugs<\/h3>\n\n\n\n
offerings<\/th>Affected or not<\/th><\/tr><\/thead>
Painkillers such as ibuprofen and acetaminophen<\/td>\u2705 Affected<\/td><\/tr>
Cold medicine, cough syrup<\/td>\u2705 Affected<\/td><\/tr>
Vitamins, dietary supplements<\/td>\u2705 Affected<\/td><\/tr>
Band-Aids, bandages, antiseptic solution<\/td>\u2705 Affected<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n

Pothole stepping is common:<\/strong> Many sellers sell Band-Aids as ordinary household products, but Amazon classifies them as OTC drugs.<\/p>\n<\/blockquote>\n\n\n\n

Category 3: Sellers of medical equipment<\/h3>\n\n\n\n
offerings<\/th>Affected or not<\/th><\/tr><\/thead>
sphygmomanometer<\/td>\u2705 Affected<\/td><\/tr>
Blood Glucose Meter and Test Strips<\/td>\u2705 Affected<\/td><\/tr>
electronic thermometer<\/td>\u2705 Affected<\/td><\/tr>
Contact lenses and care solutions<\/td>\u2705 Affected<\/td><\/tr>
Massage instruments, physiotherapy instruments (partial)<\/td>\u26a0\ufe0f Visual Function Determination<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n

Pothole stepping is common:<\/strong> Many sellers do not know the difference between \u201dordinary electronic products\u201d and \u201dmedical devices\u201d. Anything that claims to have a medical function and is used for diagnosis\/treatment\/monitoring may be categorized as a medical device.<\/p>\n<\/blockquote>\n\n\n\n

03 What happens if I don't complete a compliance audit?<\/h2>\n\n\n\n
    \n
  • Consequence #1: The item is taken off the shelves<\/strong>
    Starting April 16, items that do not pass the compliance audit will beforce off the shelves (law)<\/strong>, which is not visible to the front office and cannot be sold.<\/li>\n\n\n\n
  • Consequence 2: account limitations<\/strong>
    If multiple items under the same account are determined to be in violation, this may result:
    Sales privileges suspended
    Funds frozen<\/strong>
    Accounts are permanently banned<\/strong><\/li>\n\n\n\n
  • Consequence #3: Historical sales are traced<\/strong>
    Amazon may go back to historical sales records to request additional compliance documentation. If it can't provide it, it could face:
    Forced refunds to buyers
    fine (monetary)
    legal risk<\/li>\n<\/ul>\n\n\n\n

    Compliance emergency consulting: (micro letter: qcygscszk, cell phone: 18676749275)<\/p>\n\n\n\n

    \"\"<\/figure>\n\n\n\n

    04 What documentation is required for a compliance audit?<\/h2>\n\n\n\n

    Requirements vary by category, and the following is a list of core documents:<\/p>\n\n\n\n

    Security Alarms Category<\/h3>\n\n\n\n
    file<\/th>clarification<\/th><\/tr><\/thead>
    UL listed or equivalent safety certification<\/td>Product Safety Test Report<\/td><\/tr>
    Declaration of Compliance (DoC)<\/td>Manufacturer's declaration that the product complies with the relevant standards<\/td><\/tr>
    Product Labeling Photo<\/td>Need to include certification marks, warnings, etc.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Over-the-counter (OTC) drugs category<\/h3>\n\n\n\n
    file<\/th>clarification<\/th><\/tr><\/thead>
    FDA Registration (U.S. site)<\/td>Registration of pharmaceutical companies and listing of products<\/td><\/tr>
    CE marking (European station)<\/td>EU Medicines Compliance Certification<\/td><\/tr>
    Proof of labeling compliance<\/td>Ingredient list, dosage, warnings, etc. comply with local regulations.<\/td><\/tr>
    Good Manufacturing Practice (GMP) certification<\/td>Manufacturing plant qualification<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Medical Equipment<\/h3>\n\n\n\n
    file<\/th>clarification<\/th><\/tr><\/thead>
    FDA 510(k) or PMA (US Station)<\/td>Pre-market authorization for medical devices<\/td><\/tr>
    CE marking (European station)<\/td>EU Medical Device Regulation (MDR) Compliance<\/td><\/tr>
    ISO 13485 Certification<\/td>Medical Device Quality Management System<\/td><\/tr>
    Product Registration Certificate<\/td>Proof of medical device registration in the target market<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    05 What else can be done now? (Final action list by April 16)<\/h2>\n\n\n\n

    3 things you must do today:<\/p>\n\n\n\n

      \n
    1. Self-checked stores<\/strong>
      Login to Seller's Back Office \u2192 Inventory \u2192 Manage Inventory
      Filter by \u201dSecurity Alerts\u201d, \u201dOver-the-Counter\u201d, \u201dMedical Devices\u201d
      Check for \u201dCompliance Audit\u201d alerts<\/li>\n\n\n\n
    2. Prepare the document<\/strong>
      If there is already a certification file: immediately uploaded to the seller's back office
      If documentation is incomplete: contact the supplier or certification body to expedite the process<\/li>\n\n\n\n
    3. Contact Amazon Customer Service<\/strong>
      Open a case to confirm the progress of the audit
      Ask if there is a buffer or interim solution<\/li>\n<\/ol>\n\n\n\n

      06 What about incomplete documentation?<\/h2>\n\n\n\n

      If you're just now realizing that you need compliance paperwork, but it's too late to get it done by April 16, it's recommended:<\/p>\n\n\n\n

      Option A: Temporary downgrade (recommended)<\/strong><\/p>\n\n\n\n

      Proactively setting affected items as \u201dunsaleable\u201d<\/p>\n\n\n\n

      Avoid being forced to take down by the system and leave a record of violation<\/p>\n\n\n\n

      Re-apply for shelves when documents are complete<\/p>\n\n\n\n

      Option B: Apply for Class Migration<\/strong><\/p>\n\n\n\n

      If the product does not actually belong to these categories, you can apply for reclassification<\/p>\n\n\n\n

      Product description and evidence required<\/p>\n\n\n\n

      Option C: Accreditation on an emergency basis<\/strong><\/p>\n\n\n\n

      Some certifications can be expedited (2-4 weeks)<\/p>\n\n\n\n

      Costs more, but keeps the Listing<\/p>\n\n\n\n

      07 Final Reminder<\/h2>\n\n\n\n

      April 16 is not a suggestion, it's a red herring.<\/p>\n\n\n\n

      Amazon has significantly tightened its grip on compliance this year, from the EU GPSR, the UK EPR, and now mandatory access rules, the trend is clear: no compliance documents, no sales rights.<\/p>\n\n\n\n

      If you sell security alerts, OTC, medical devices, go check your back office right now.<\/p>\n\n\n\n

      Don't wait until you're taken off the market to regret it.<\/p>\n\n\n\n

      \n\n\n\n

      Emergency consultation on compliance issues: (micro letter: qcygscszk, cell phone: 18676749275)<\/p>\n\n\n\n

      \"\"<\/figure>\n\n\n\n

      <\/p>","protected":false},"excerpt":{"rendered":"

      On April 16th, a new regulation will be implemented simultaneously on all three major Amazon US\/Canada\/European sites.<\/p>\n

      Sellers involved in the three main categories of safety alerts, over-the-counter medications, and medical devices, if you haven't completed a compliance audit, your items will be taken right off the shelves and you may even face account restrictions.<\/p>\n

      It's not an early warning, it's an ultimatum.<\/p>\n

      If you sell smoke alarms, blood pressure monitors, band-aids, contact lens care solution ...... this is a must read.<\/p>","protected":false},"author":10,"featured_media":8959,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17,18,13],"tags":[211,212],"class_list":["post-9074","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-allguide","category-recomguide","category-guide","tag-211","tag-212"],"yoast_head":"\n\u7d27\u6025\u901a\u77e5\uff01\u4e9a\u9a6c\u900a4\u670816\u5f00\u59cb\u5f3a\u5236\u5ba1\u6838\uff0c\u8fd93\u7c7b\u5356\u5bb6\u4e0d\u770b\u5c31\u88ab\u4e0b\u67b6 - \u4f01\u8d22\u76c8<\/title>\n<meta name=\"description\" content=\"%\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.qicaiying.cn\/en\/archives\/9074\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u7d27\u6025\u901a\u77e5\uff01\u4e9a\u9a6c\u900a4\u670816\u5f00\u59cb\u5f3a\u5236\u5ba1\u6838\uff0c\u8fd93\u7c7b\u5356\u5bb6\u4e0d\u770b\u5c31\u88ab\u4e0b\u67b6 - 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