{"id":227759,"date":"2024-10-02T13:34:22","date_gmt":"2024-10-02T00:34:22","guid":{"rendered":"https:\/\/legalvision.co.nz\/?p=227759"},"modified":"2024-10-14T19:04:45","modified_gmt":"2024-10-14T06:04:45","slug":"selling-medical-devices","status":"publish","type":"post","link":"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/selling-medical-devices\/","title":{"rendered":"Key Points to Know When Selling Medical Devices"},"content":{"rendered":"\n<p>If you manufacture or distribute medical devices and are looking to enter the New Zealand market, there are several important legal requirements you need to be aware of. NZ has <a href=\"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/therapeutic-product\/\">specific regulations around the importation, sponsorship, notification and advertising of medical devices<\/a>, which act to protect consumers. This article will outline the key points businesses should know before selling medical devices in New Zealand.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Definition of a Medical Device<\/h2>\n\n\n\n<p>Under NZ law, a medical device is any instrument, apparatus, appliance, or other article intended for therapeutic use on humans, but does not achieve its principal action through pharmacological, immunological, or metabolic means.&nbsp;<\/p>\n\n\n\n<p>Therapeutic purposes means any of the following purposes:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect, or injury;<\/li>\n\n\n\n<li>influencing, inhibiting, or modifying a physiological process;&nbsp;<\/li>\n\n\n\n<li>testing the susceptibility of persons to a disease or ailment;&nbsp;<\/li>\n\n\n\n<li>influencing, controlling, or preventing conception;&nbsp;<\/li>\n\n\n\n<li>testing for pregnancy; and&nbsp;<\/li>\n\n\n\n<li>investigating, replacing, or modifying parts of the human anatomy.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p>Therefore, many products have a therapeutic purpose, including (but not limited to):<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>surgical instruments;<\/li>\n\n\n\n<li>contact lenses;<\/li>\n\n\n\n<li>dental equipment;<\/li>\n\n\n\n<li>blood pressure cuffs;<\/li>\n\n\n\n<li>thermometers; and&nbsp;<\/li>\n\n\n\n<li>condoms.&nbsp;<\/li>\n<\/ul>\n\n\n    <div class=\"my-7 lg:my-10 border-y-2 border-gray-100 py-7 lg:py-10 flex flex-col sm:flex-row items-start gap-10\">\n                    <img decoding=\"async\" class=\"w-52 mx-auto my-0! rounded\" src=\"https:\/\/img.legalvision.com.au\/wp-content\/uploads\/sites\/2\/2021\/12\/22115855\/cytonn-photography-GJao3ZTX9gU-unsplash-e1640129621597.jpg\" alt=\"Front page of publication\"\n                 loading=\"lazy\" width=\"208\" height=\"298\">\n                <section>\n            <div class=\"text-2xl font-bold\">Commercial Contracts Checklist<\/div>\n            <div class=\"body-text\">\n                <p>To protect your business, ensure supplier contracts meet your business\u2019 needs. Our free Commercial Contracts Checklist will help.<\/p>\n            <\/div>\n            \n\n<a href=\"https:\/\/go.legalvision.co.nz\/Commercial_Contracts_Guide_NZ.html\" class=\" block px-5 py-3.5 max-w-fit bg-orange button__hover transition rounded text-white font-bold text-lg no-underline uppercase leading-tight text-center\" target=\"\" rel=\"\">Download Now<\/a>        <\/section>\n    <\/div>\n\n\n\n\n<h2 class=\"wp-block-heading\">Requirement for a Sponsor&nbsp;<\/h2>\n\n\n\n<p>All medical devices sold in NZ must have a sponsor, an NZ-based person or organisation that is the legal supplier of the devices. Usually, the sponsor is the entity responsible for <a href=\"https:\/\/legalvision.co.nz\/corporations\/manufacturing-overseas\/\">importing the devices into NZ<\/a> or manufacturing the devices within the country.&nbsp;<\/p>\n\n\n\n<p>To legally act as a sponsor, the entity must be registered and have a principal place of business in NZ. Key responsibilities of the sponsor include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ensuring the medical devices are safe for their intended purpose;<\/li>\n\n\n\n<li>notifying the Web Assisted Notification of Devices (WAND) database with the details of the devices within 30 days of beginning to sell them;<\/li>\n\n\n\n<li>maintaining accurate device information in the WAND database;<\/li>\n\n\n\n<li>keeping distribution records to enable product recalls if needed;<\/li>\n\n\n\n<li>immediately notifying Medsafe (the medicines and medical devices safety authority) of any recalls or corrective actions; and<\/li>\n\n\n\n<li>ensuring advertising and labelling comply with regulations.<\/li>\n<\/ul>\n\n\n\n<div  class=\"box box--icon box--info\">\n    <p>For manufacturers based overseas without an NZ office, the entity responsible for importing your products into NZ will act as the sponsor and must fully comply with these regulations.<\/p>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Notification to the WAND Database<\/h3>\n\n\n\n<p>Before being able to sell medical devices in NZ, the sponsor must submit a notification about the devices to the WAND database. This involves providing details on the:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>risk classification;<\/li>\n\n\n\n<li>manufacturer;<\/li>\n\n\n\n<li>product description; and&nbsp;<\/li>\n\n\n\n<li>contact details for the sponsor.<\/li>\n<\/ul>\n\n\n\n<p>Notification is free but a legal requirement. Failure to make accurate and timely notifications can result in penalties.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Distribution Records and Recalls<\/h3>\n\n\n\n<p>Maintaining proper distribution records is critical for medical device sponsors. If a product defect or safety issue requires a recall, the sponsor must be able to trace which customers have been supplied with the affected devices.&nbsp;<\/p>\n\n\n\n<div  class=\"box box--icon box--star\">\n    <p>Sponsors should have a recall procedure documented in writing, outlining the process for executing a product recall, issuing consumer notifications and reporting to the regulator. These records enable targeted and compliant recalls.<\/p>\n<\/div>\n\n\n\n\n<a href=\"#content-next\"\n   class=\"block p-4 mt-10 text-xl font-bold text-center text-white no-underline bg-gray-800 rounded-t-xl\">\n    Continue reading this article below the form\n    <i class=\"text-xl fa-regular fa-arrow-down\"><\/i>\n<\/a>\n<div class=\"px-6 pt-10 pb-12 mb-10 text-center bg-gray-100 rounded-b-xl sm:px-12 test\">\n    <div class=\"mb-8 text-2xl font-bold text-orange\">\n        Need legal advice?\n        <br>\n        <span class=\"text-lg not-prose\">\n                            Call <a href=\"tel:+64800005570\" class=\"not-prose\">0800 005 570<\/a> for urgent assistance.\n                <br>\n                Otherwise, complete this form, and we will contact you within one business day.\n                    <\/span>\n    <\/div>\n\n    \n\n<div class=\"not-prose flex justify-center text-left gform_input_bg_white    \">\n    <script>\nvar 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       } else {            triggerPostRender();        }    } );} );\n<\/script>\n<\/div>\n<\/div>\n<div id=\"content-next\"><!-- scroll anchor --><\/div>\n<h2 class=\"wp-block-heading\">Consumer Protection Laws<\/h2>\n\n\n\n<p>When selling medical devices to consumers (individuals purchasing for personal\/domestic use), the <em><a href=\"https:\/\/www.legislation.govt.nz\/act\/public\/1993\/0091\/latest\/DLM311053.html\">Consumer Guarantees Act 1993<\/a><\/em> provides <a href=\"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/consumer-guarantees-apply\/\">certain automatic guarantees<\/a> that products must:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>meet minimum quality standards;<\/li>\n\n\n\n<li>be fit for purpose;<\/li>\n\n\n\n<li>arrive within a reasonable timeframe; and&nbsp;<\/li>\n\n\n\n<li>be reasonably priced.<\/li>\n<\/ul>\n\n\n\n<p>If you do not meet these guarantees, consumers have the right to remedies such as a repair, replacement or refund.&nbsp;<\/p>\n\n\n\n<p>Additionally, the <a href=\"https:\/\/www.legislation.govt.nz\/act\/public\/1986\/0121\/latest\/DLM96439.html\"><em>Fair Trading Act 1986<\/em> <\/a>prohibits misleading marketing claims or deceptive conduct that could mislead consumers. All product claims must be truthful, accurate and substantiated.\u00a0\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Key Takeaways&nbsp;<\/h2>\n\n\n\n<p>By understanding and addressing the regulations around sponsorship, notification, record-keeping, consumer laws, and marketing, your business can compliantly sell medical devices to companies and consumers across NZ. It is important to be aware that medical devices are highly regulated, and it is always recommended to seek bespoke legal advice before selling medical devices in NZ.&nbsp;&nbsp;<\/p>\n\n\n\n<p>If your business sells medical devices, our experienced <a href=\"https:\/\/legalvision.co.nz\/business-lawyers-lp-new-zealand\">business lawyers<\/a> can assist as part of our LegalVision membership. For a low monthly fee, you will have unlimited access to lawyers to answer your questions and draft and review your documents. Call us today <a href=\"tel:+64800005570\" class=\"AVANSERnumber dynamic-number\">0800 005 570<\/a> or visit our <a href=\"https:\/\/legalvision.co.nz\/membership\/\">membership page<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Frequently Asked Questions<\/h2>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1727828610760\"><strong class=\"schema-faq-question\">What are the requirements to sell medical devices in New Zealand?<\/strong> <p class=\"schema-faq-answer\">You need to have a New Zealand-based sponsor who ensures the medical devices meet safety, notification, and record-keeping requirements.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1727828614023\"><strong class=\"schema-faq-question\">Which consumer protection laws affect medical devices in New Zealand?<\/strong> <p class=\"schema-faq-answer\">The <em>Consumer Guarantees Act 1993<\/em> requires devices to meet quality standards, be fit for purpose and have accurate claims. It offers remedies like repairs, replacements, or refunds.<\/p> <\/div> <\/div>\n\n\n\n\n<div class=\"not-prose m-feedback-prompt\">\n    <!-- Thumbs up\/down bar -->\n    <div class=\"m-feedback-prompt__main\">\n        <div class=\"m-feedback-prompt__title\">Was this article helpful?<\/div>\n        <div>\n            <!--span class=\"m-feedback-prompt__button--text\">Thanks!<\/span-->\n            <button type=\"button\" class=\"m-feedback-prompt__button m-feedback-prompt__button--yes\"\n                    data-analytics-link=\"feedback-prompt:yes\" aria-label=\"Agree\">\n                <i class=\"fa-regular fa-thumbs-up fa-3x\"><\/i>\n            <\/button>\n            <button type=\"button\" class=\"m-feedback-prompt__button m-feedback-prompt__button--no\"\n                    data-analytics-link=\"feedback-prompt:no\" aria-label=\"Disagree\">\n                <i class=\"fa-regular fa-thumbs-down fa-3x\"><\/i>\n            <\/button>\n        <\/div>\n    <\/div>\n\n    <!-- Feedback form -->\n    <div class=\"m-feedback-prompt__form\">\n        <div class=\"m-feedback-prompt__form--thanks \">\n            <div>Thanks!<\/div>\n            <p>\n                We appreciate your feedback \u2013 your submission has been successfully received.            <\/p>\n        <\/div>\n        <form id=\"contact-form\" class=\"m-feedback-prompt__form--form\" action=\"\" method=\"post\">\n            <input type=\"hidden\" id=\"authenticity_token\" name=\"authenticity_token\" value=\"ed19fd34f0\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/api\/wp\/v2\/posts\/227759\" \/>            <input value=\"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/selling-medical-devices\/\" type=\"hidden\" name=\"currenturl\"\n                   id=\"currenturl\">\n            <input value=\"Key Points to Know When Selling Medical Devices\" type=\"hidden\" name=\"currenttitle\"\n                   id=\"currenttitle\">\n            <label>\n                <!-- display on thumbs-up -->\n                <span class=\"m-feedback-prompt__feedback m-feedback-prompt__feedback--yes\">\n                    Can you tell us <span class=\"font-semibold\">why<\/span> you found it helpful?\n                <\/span>\n\n                <!-- display on thumbs-down -->\n                <span class=\"m-feedback-prompt__feedback m-feedback-prompt__feedback--no text-lg\">\n                    How can we better improve this article?\n                <\/span>\n                <textarea name=\"feedbackmessage\" id=\"feedbackmessage\" required><\/textarea>\n            <\/label>\n\n            <div class=\"m-feedback-prompt__form--error\" id=\"form-submit-error\"><\/div>\n            <button id=\"submit-contact-form-button\" type=\"submit\" name=\"commit\" class=\"m-feedback-prompt__form--submit\"\n                    data-analytics-link=\"feedback-prompt:submit\">\n                Submit            <\/button>\n        <\/form>\n    <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>If you manufacture or distribute medical devices and are looking to enter the New Zealand market, there are several important legal requirements you need to be aware of. NZ has specific regulations around the importation, sponsorship, notification and advertising of medical devices, which act to protect consumers. This article will outline the key points businesses<a href=\"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/selling-medical-devices\/\">Continue reading <span class=\"sr-only\">&#8220;Key Points to Know When Selling Medical Devices&#8221;<\/span><\/a><\/p>\n","protected":false},"author":13388,"featured_media":215472,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","editor_notices":[],"footnotes":""},"categories":[8],"tags":[25,85,346,2237],"class_list":["post-227759","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-and-compliance","tag-small-business","tag-consumer-guarantees","tag-regulations","tag-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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It offers remedies like repairs, replacements, or refunds.","inLanguage":"en-NZ"},"inLanguage":"en-NZ"}]}},"_links":{"self":[{"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/posts\/227759","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/users\/13388"}],"replies":[{"embeddable":true,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/comments?post=227759"}],"version-history":[{"count":4,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/posts\/227759\/revisions"}],"predecessor-version":[{"id":227847,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/posts\/227759\/revisions\/227847"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/media\/215472"}],"wp:attachment":[{"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/media?parent=227759"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/categories?post=227759"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalvision.co.nz\/api\/wp\/v2\/tags?post=227759"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}