{"id":52413,"date":"2023-02-14T15:32:57","date_gmt":"2023-02-14T10:02:57","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=52413"},"modified":"2023-02-14T15:32:59","modified_gmt":"2023-02-14T10:02:59","slug":"medical-device-registration-in-south-africa","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/","title":{"rendered":"Medical Device Registration in South Africa \u2013 All You Need to Know"},"content":{"rendered":"\n<p>Medical device registration in South Africa is governed under the provision of the<strong> Medicines and Related Substances Act of 1965<\/strong><sup><a href=\"https:\/\/www.gov.za\/documents\/drugs-control-act-7-jul-1965-0000\"><strong>[1]<\/strong><\/a><\/sup>. All the manufacturers, importers and distributors are therefore advised to adhere to the rules and regulations laid in the act in order to get the medical device registration in South Africa. \u00a0<\/p>\n\n\n\n<p>The aim of the Medical\nDevice Establishment Licence is to help the South African Health Products\nRegulatory Authority in maintaining the record of:&nbsp;<\/p>\n\n\n\n<ul><li>All the manufacturers\nof medical devices within the country;&nbsp;<\/li><li>All the importers and\ndistributors of medical devices within the country.&nbsp;<\/li><li>Along with this,\nMedical Device Establishment Licence helps in classifying the medical devices\nand IVDs as per their risk assessment and intended use.&nbsp; &nbsp;<\/li><\/ul>\n\n\n\n<p>In the recent course of\naction, all the domestic medical device manufacturers and distributors were\nasked to register by August 2017. Similarly, all the domestic wholesalers were\nrequired to register by February 2018 and all foreign companies we required to\nobtain MCC licenses.<\/p>\n\n\n\n<p>Before you enter into\nthe medical device market, you must question yourself on the following aspects:<\/p>\n\n\n\n<ol><li>What\nis the ultimate use of your device?<\/li><li>What\nis the market potential of your device?<\/li><li>Is\nyour device patentable?<\/li><li>What\nare the regulatory requirements regarding your device?&nbsp;<\/li><li>Does the medical device address the current needs of the society?\u00a0 <\/li><\/ol>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Medical_device_definition_as_per_South_African_laws\" >Medical device definition as per South African laws<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Classification_Rules_of_Medical_Devices_in_South_Africa\" >Classification Rules of Medical Devices in South Africa<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Medicines_and_Related_Substances_Control_Act_of_1965\" >Medicines&nbsp;and&nbsp;Related&nbsp;Substances&nbsp;Control&nbsp;Act\nof 1965<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Who_all_can_apply_for_Medical_Device_Registration_in_South_Africa\" >Who all can apply for Medical Device\nRegistration in South Africa?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Documents_Required_for_Medical_Device_Registration_in_South_Africa\" >Documents\nRequired for Medical Device Registration in South Africa<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Process_for_Medical_Device_Registration_in_South_Africa\" >Process for Medical Device Registration in South Africa<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Applicable_QMS\" >Applicable\nQMS<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Additional_Guidelines_Regarding_Medical_Device_Registration_in_South_Africa\" >Additional Guidelines Regarding Medical Device Registration\nin South Africa<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/corpbiz.io\/learning\/medical-device-registration-in-south-africa\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_device_definition_as_per_South_African_laws\"><\/span>Medical device definition as per South African laws<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As\nper the provisions of the Act a medical device is an instrument, apparatus,\nimplant, implement, machine, appliance, reagent for in vitro use, software,\nmaterial or other similar or related article used by a manufacturer alone or in\ns combination for the better health of human beings or for the purposes as\nmentioned below: <\/p>\n\n\n\n<ul><li>Diagnosis, prevention, monitoring, treatment\/alleviation of disease;<\/li><li>Diagnosis, monitoring, treatment, of an injury;<\/li><li>Investigation, replacement, modification\/support of the anatomy or of a physiological process;<\/li><li>Supporting or sustaining a life;<\/li><li>Controlling conception;<\/li><li>Disinfection of medical devices.  <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_Rules_of_Medical_Devices_in_South_Africa\"><\/span>Classification Rules of Medical Devices in South Africa<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p> All the medical devices in South Africa are classified in four (4) categories, as described below: <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Classification<\/strong>\n  <\/td><td>\n  <strong>Level\n  of risk<\/strong>\n  <\/td><\/tr><tr><td>\n  Class A\n  <\/td><td>\n  Low risk\n  <\/td><\/tr><tr><td>\n  Class B\n  <\/td><td>\n  Low\u2013moderate risk\n  <\/td><\/tr><tr><td>\n  Class C\n  <\/td><td>\n  Moderate \u2013 high risk\n  <\/td><\/tr><tr><td>\n  Class D\n  <\/td><td>\n  High risk Where risk relates to the\n  patient or to public health\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medicines_and_Related_Substances_Control_Act_of_1965\"><\/span>Medicines&nbsp;and&nbsp;Related&nbsp;Substances&nbsp;Control&nbsp;Act\nof 1965<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before we jump on medical\ndevice registration in South Africa, here are some of the important sections\nunder the act that you must know<strong>. <\/strong><strong><\/strong><\/p>\n\n\n\n<ul><li><em>Section 2<\/em> of the talks act about the establishment of South African health products regulatory authority <\/li><li><em>Section 2A <\/em>of the talks act about the objects of authority <\/li><li><em>Section 2B <\/em>of the talks act about the functions of authority <\/li><li><em>Section 2C <\/em>of the talks act about the composition of board<\/li><li><em>Section 14 <\/em>of the talks act about the prohibition on the sale of medicines, medical devices\/IVDs which are subject to registration &amp; are not registered <\/li><li><em>Section 15 <\/em>of the talks act about the registration of medicines, medical devices or IVDs <\/li><li><em>Section 15A <\/em>of the talks act about the amendment of entries in register <\/li><li><em>Section 15B <\/em>of the talks act about the transfer of certificate of registration<\/li><li><em>Section 15C <\/em>of the talks act about the measures to make sure the supply of more affordable medicines <\/li><li><em>Section 16 <\/em>of the talks act about the cancellation of registration <\/li><li><em>Section 17 <\/em>of the talks act about the notification of registration or cancellation thereof <\/li><li><em>Section 18 <\/em>of the talks act about the labels and advertisements<\/li><li><em>Section 18B <\/em>of the talks act about the sampling of medicines, medical devices or IVDs <\/li><li><em>Section 18C <\/em>of the talks act about the marketing of medicines, medical devices or IVDs <\/li><li><em>Section 19 <\/em>of the talks act about the prohibition on sale of medicines, medical devices\/IVDs which don&#8217;t comply with prescribed requirements &amp; furnishing of information regarding medicines, medical devices\/IVDs to the Authority<\/li><li><em>Section 20 <\/em>of the talks act about the publication\/distribution of false advertisements concerning medicines, medical devices\/IVDs<\/li><li><em>Section 21 <\/em>of the talks act about the authority may authorize sale of unregistered medicines, medical devices or IVDs for certain purposes <\/li><li><em>Section 22 <\/em>of the talks act about the authority to cause certain information to be furnished <\/li><li><em>Section 22A <\/em>of the talks act about the control of medicines, Scheduled substances, medical devices &amp; IVDs <\/li><li><em>Section 22B <\/em>of the talks act about the publication of information relating to medicines, scheduled substances, medical devices\/IVDs<\/li><li><em>Section 22C <\/em>of the talks act about the licensing <\/li><li>Section 22D of the talks act about the period of validity and renewal of licence <\/li><li>Section 22E of the talks act about the suspension and cancellation of licence<\/li><li>Section 22G of the talks act about the pricing committee <\/li><li><em>Section 22H <\/em>of the talks act about the purchase &amp; sale of medicines, medical devices, IVDs &amp; Scheduled substances by wholesalers <\/li><li><em>Section 23 <\/em>of the talks act about the disposal of undesirable medicines, medical devices\/IVDs <\/li><li><em>Section 24 <\/em>of the talks act about the appeal against decision of the director general <\/li><li><em>Section 24A <\/em>of the talks act about the appeal against decision of authority <\/li><li><em>Section 25 <\/em>of the talks act about the privileges of authority and committees <\/li><li><em>Section 26 <\/em>of the talks act about the inspectors.<\/li><li><em>Section 29 <\/em>of the talks act about the offences <\/li><li><em>Section 30 <\/em>of the talks act about the penalties<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_all_can_apply_for_Medical_Device_Registration_in_South_Africa\"><\/span>Who all can apply for Medical Device\nRegistration in South Africa?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According\nto <em>Section 22C(1)(b)<\/em> of the Act, the\nAuthority may grant a licence to a manufacturer, wholesaler, or distributor of\na medicine or medical device to <\/p>\n\n\n\n<ol><li>Manufacture,\nimport, or export; or<\/li><li>Import,\ndistribute, or export. <\/li><\/ol>\n\n\n\n<p> Note: No maker, importer, or exporter may import or export any medical device or IVD unless the South African Health Products Regulatory Authority has granted the individual a licence in accordance with <em>Section 22C(1)(b)<\/em> of the Act.  <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_Medical_Device_Registration_in_South_Africa\"><\/span>Documents\nRequired for Medical Device Registration in South Africa<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the list of documents required for Medical Device Registration in South\nAfrica:<\/p>\n\n\n\n<ul><li>An application form as per the prescribed format<\/li><li>Labels, IFUs, Package Inserts or promotional materials<\/li><li>Letter of appointment as an authorised representative of the original manufacturer.<\/li><li>Copy of the EC Certificate(s) issued by a recognised notified body<\/li><li>Copy of the EC Declaration of Conformity issued by the original manufacturer<\/li><li>Technical documentation<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Process_for_Medical_Device_Registration_in_South_Africa\"><\/span>Process for Medical Device Registration in South Africa<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the process of <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device registration<\/strong><\/a> in South Africa: <\/p>\n\n\n\n<ul><li>Select an authorised representative (AR) for South Africa<\/li><\/ul>\n\n\n\n<p>(Note: Medical device companies that have applied for a SAHPRA licence\nare required to nominate an Authorised Representative, who must be a local\nSouth African citizen. For all location where the company operate,\nthe&nbsp;company must appoint&nbsp;one representative on all those locations.\nThe representative is in charge of upholding the rules, laws, and regulations.)<\/p>\n\n\n\n<ul><li>Show that the medical device adheres to all&nbsp;the essential principles.<\/li><li>To demonstrate conformity, submit an application for the CA certificate\nto a Conformity Assessment Body (CAB) or an International Notified Body.<\/li><li>If your application is approved and you have received your CA\ncertificate, then RA will prepare your DoC (Declaration of Conformity)<\/li><li>AR then submits the application to the Medicines Control Council (MCC)<\/li><li>A medical device will be registered with the Medical Device Registry.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Applicable_QMS\"><\/span>Applicable\nQMS<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Manufacturers and distributors that hold a SAHPRA licence are required to show proof of the company&#8217;s ISO 13485 accreditation from a recognised conformity assessment agency.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Additional_Guidelines_Regarding_Medical_Device_Registration_in_South_Africa\"><\/span>Additional Guidelines Regarding Medical Device Registration\nin South Africa<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are\nthe additional guidelines regarding Medical Device Registration in South\nAfrica:<\/p>\n\n\n\n<ul><li>All submissions must be made in English language only.<\/li><li>There\nis no need for local testing. However, additional permits can be needed for\nelectronic products listed in the Schedule for Listed Electronic Products\nRegulation R1302 of 1991.<\/li><li>There\nis no requirement for an inspection abroad. However, the overseas producers\nmust show that they are in accordance with the MDACS&#8217;s conformity assessment\nrequirements.<\/li><li>Since\nthe Radiation Control Department is now a component of SAHPRA, there will only\nbe one official fee and submission needed for both a SAHPRA licence and\nradiation control, even though there will be two licences granted.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In addition to discussing medical device registration in South Africa, this article also discussed the classification guidelines for classifying medical devices (Non-IVDs) and IVDs. Today, South Africa&#8217;s healthcare system is prepared for the digital age, the nation has the skills and capacity to manufacture medical devices, and it stands out from other African nations thanks to its highly competitive and innovative scene. In light of its efforts to modernise its industry, developing nations can learn from it. In order to ensure that there are medical devices available in South Africa that meet an acceptable level of safety, quality, and performance, the medical device section of SAHPRA oversees the licencing of medical device establishments &amp; the registration of medical devices (including IVDs and non-IVD medical devices).<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-obstetrical-and-gynaecological-medical-devices\/\">CDSCO Registration For Obstetrical And Gynaecological Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical device registration in South Africa is governed under the provision of the Medicines and Related Substances Act of 1965[1]. All the manufacturers, importers and distributors are therefore advised to adhere to the rules and regulations laid in the act in order to get the medical device registration in South Africa. \u00a0 The aim of [&hellip;]<\/p>\n","protected":false},"author":48,"featured_media":52424,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[3083],"acf":{"service_id":"385"},"authorName":"Astitva Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/12\/MicrosoftTeams-image-27.jpg","authorDescription":"Astitva Kumar is an advocate by profession and has completed her BBA. LLB from IP University. She is an avid reader, researcher, and legal writer. Her areas of interest include mediation, conflict resolution, finance, cyber laws, and taxation.","postViews":5751,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52413"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/48"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=52413"}],"version-history":[{"count":8,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52413\/revisions"}],"predecessor-version":[{"id":52426,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52413\/revisions\/52426"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/52424"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=52413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=52413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=52413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}