hg-temple/compliance.html at main · hemantgdev/hg-temple · GitHub

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<!DOCTYPE html>
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    <title>Non-FDA Compliance - Hemant @ Temple</title>
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<body>
    <div class="container">
        <h1 class="main-title"><a href="index.html">HEMANT @ TEMPLE</a></h1>

        <nav class="menu">
            <a href="understanding.html">My Understanding of Temple</a>
            <a href="competitive.html">Competitive Analysis</a>
            <a href="gtm.html">Go-To-Market</a>
            <a href="approvals.html">Approvals Needed</a>
            <a href="about.html">About Me</a>
        </nav>

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        <h2 class="page-title">Non-FDA Compliance</h2>

        <div class="content">
            <h3>USA (Non-FDA Wellness Route) – Requirements:</h3>

            <ul>
                <li>FCC certification and SAR testing for Bluetooth/Wi-Fi (radio/RF compliance)</li>
                <li>Battery safety: UN 38.3 (transport), UL/IEC 62368-1 (consumer electronics)</li>
                <li>Biocompatibility testing (ISO 10993 irritation/sensitization) for skin contact (strongly recommended)</li>
                <li>Ingress protection (IP67/IP68) if claiming waterproof/sweatproof</li>
                <li>Truthful, substantiated advertising (FTC compliance)</li>
                <li>Privacy and security: FTC Health Breach Notification Rule, state privacy laws (e.g., CA CPRA, WA MHMDA), clear user consent, encryption, breach notification plan</li>
                <li>E-waste and labeling: country of origin, importer details, warranty, care instructions</li>
                <li>No FDA registration, listing, or QMS required if you avoid medical claims</li>
            </ul>

            <h3>UAE (Wellness Device Route) – Requirements:</h3>

            <ul>
                <li>TDRA type approval for wireless/Bluetooth/Wi-Fi (telecom/RF compliance)</li>
                <li>Electrical safety: IEC/UL 62368-1; Certificate of Conformity (often via ESMA/ECAS)</li>
                <li>UAE RoHS (hazardous substances) compliance, ECAS certificate</li>
                <li>Battery safety: UN 38.3 for lithium cells/packs</li>
                <li>Biocompatibility (ISO 10993) for skin contact (recommended)</li>
                <li>Ingress protection (IP67/IP68) if claiming waterproof</li>
                <li>Bilingual labeling (Arabic/English), importer details, warranty, safety info</li>
                <li>Privacy and data protection: PDPL (Federal Law No. 45/2021), consent, data minimization, secure storage</li>
                <li>No MOHAP (medical device) registration needed if you avoid medical claims</li>
            </ul>

            <h3>What we must avoid in both cases:</h3>

            <ul>
                <li>Any claims or implicit claims to diagnose, treat, screen for, or prevent diseases/medical conditions</li>
                <li>Marketing or implying the device provides medical advice, replaces medical devices, or is for use in managing health conditions</li>
                <li>Use of "medical," "diagnostic," "therapy," or similar terms in product copy, packaging, or advertising</li>
                <li>Any unsubstantiated or misleading performance/safety claims</li>
                <li>Claims about use for children or vulnerable populations without proper compliance</li>
            </ul>
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