{"id":22030,"date":"2022-07-26T15:26:28","date_gmt":"2022-07-26T13:26:28","guid":{"rendered":"https:\/\/www.thema-med.eu\/?p=22030"},"modified":"2022-07-26T16:38:09","modified_gmt":"2022-07-26T14:38:09","slug":"thailand-preferential-route-for-devices-already-registered-in-singapore","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/07\/26\/thailand-preferential-route-for-devices-already-registered-in-singapore\/","title":{"rendered":"THAILAND: preferential route for devices already registered in Singapore"},"content":{"rendered":"<p>On 20<sup>th<\/sup> June 2022, the <strong>TFDA<\/strong> (the Thai FDA) established the expansion of the <strong>Singapore Reliance Route<\/strong> programme, initially tested only with Class D\/Class 4 products, to all Class B, C and D Medical Devices.<\/p>\n<p>Effective immediately and enjoying the preferential pathway, the Thai FDA will review applications in a maximum of 60 working days for the devices that meet the <strong>eligibility<\/strong> requirements, which are:<\/p>\n<ul>\n<li>Passing the approval process in order to be marketed in Singapore at HSA;<\/li>\n<li>Being actively listed in the Singapore Medical Devices Register;<\/li>\n<li>Using the Common Submission Dossier (CSDT) format to apply for market access.<\/li>\n<\/ul>\n<h3><strong>How to place medical devices on the Thai market under licence in Singapore?<\/strong><\/h3>\n<p>Manufacturers must appoint a Thai <strong>Authorised Local Representative<\/strong> to submit a standard e-submission application to the Thai FDA&#8217;s Medical Device Control Division.<\/p>\n<p>The applications using the Singapore Reliance Route not only will include the <strong>exact<\/strong> same CSDT <strong>technical documents<\/strong> submitted to the HSA in Singapore but they will also have to <strong>involve the Local Representative in Singapore<\/strong> to enable the HSA (Regulatory Authority in Singapore) to send their assessment documents to the TFDA (Regulatory Authority in Thailand).<\/p>\n<h3><strong>&gt;&gt;&gt; Do you want to market your devices in Thailand?<\/strong><\/h3>\n<p>Get <strong><u>strategic regulatory advice<\/u><\/strong> from Thema experts now to understand the <strong>requirements and procedures<\/strong> to get products onto the market in Thailand quickly and in full compliance with regulations.<\/p>\n<p><strong>Are you determined to proceed? <\/strong>Ask us for support with the <strong><u>international registration<\/u> <\/strong>process at the TFDA and, with the <strong><u>Local Representative<\/u> <\/strong>Thema in Thailand, you will be able to market your devices fully independently.<\/p>\n<p><strong><u>Contact our Customer Service<\/u><\/strong> for further information.<\/p>\n<p>Sources:<\/p>\n<p><a href=\"https:\/\/www.fda.moph.go.th\/sites\/FDA_EN\/SitePages\/Medical.aspx?IDitem=LawsAndRegulations\">https:\/\/www.fda.moph.go.th\/sites\/FDA_EN\/SitePages\/Medical.aspx?IDitem=LawsAndRegulations<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 20th June 2022, the TFDA (the Thai FDA) established the expansion of the Singapore Reliance Route programme, initially tested only  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":22016,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-22030","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the 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