{"id":17339,"date":"2021-02-22T14:07:11","date_gmt":"2021-02-22T13:07:11","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17339"},"modified":"2023-01-24T14:59:02","modified_gmt":"2023-01-24T13:59:02","slug":"south-east-asian-medical-device-regulatory-updates","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2021\/02\/22\/south-east-asian-medical-device-regulatory-updates\/","title":{"rendered":"SOUTHEAST ASIA: Medical Devices regulatory updates in Philippines, Vietnamese and Malaysian markets"},"content":{"rendered":"\n<p>Below there are the latest news on the <strong>regulatory updates<\/strong> of Medical Devices in\nsome <strong>South-East Asian markets <\/strong>of\nparticular relevance and interest.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/02\/aggiornamenti-regolatori-filippine-vietnam-malesia-1024x536.png\" alt=\"Medical Device regulatory updates in Philippine, Vietnamese and Malaysian markets\" class=\"wp-image-17290\"\/><figcaption>Medical Device regulatory updates in Philippine, Vietnamese and Malaysian markets<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Philippines: FDA publishes new circular for the registration of Medical Devices<\/strong><\/h2>\n\n\n\n<p>At the beginning of January 2021,\nthe <strong>Philippines Food and Drug Administration (FDA<\/strong>) issued <strong>circular n\u00b0\n2021-001<\/strong> on the <strong>product standards <\/strong>to\nwhich Medical Devices must comply for notification or registration.<\/p>\n\n\n\n<p>The circular was\nissued pursuant to the Administrative Decree n. 2018-002 to provide product\nstandards defined as \u201cmedical device standards set\u201d, to which local Manufacturers,\nImporters and\/or Distributors must comply to obtain a <strong>certificate of Medical Device notification (CMDN)<\/strong> or a <strong>certificate of Medical Device registration\n(CMDR<\/strong>).<\/p>\n\n\n\n<p>Moreover, at the\nend of January, the Philippines Food and Drug Administration (FDA) relaunched\nthe <strong>verification portal <\/strong>for <strong>Medical Devices <\/strong>which provides complete\nlists of FDA-approved establishments and registered health products. Consumers\ncan freely enter the portal to have access to information of safe and quality\nproducts.<\/p>\n\n\n\n<p>For devices\nregistered in the portal, they are publicly available information such as the\nname of the product, certificate of registration, name of the Manufacturer,\ncountry of origin, Importer and dates of validity of the registration.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Vietnam: published document on the preparation of Medical Device registrations<\/strong><\/h2>\n\n\n\n<p>Recently, the <strong>Vietnam\u2019s Ministry\nof Health (MoH)<\/strong> published the <strong>document n\u00b0 7395\/BYT-TB-CT<\/strong> on the\nprocedures for forwarding <strong>Medical Device\nRegistrations<\/strong>. The purpose of this document is to help applicants to <strong>better understand and respect the\nregulation<\/strong> in order to be able to proceed as quickly as possible to the\nevaluation of applications for registration and, consequently, to <strong>facilitate the circulation <\/strong>of Medical\nDevices on the Vietnamese market. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Malaysia: published guidelines on masks for medical use<\/strong><\/h2>\n\n\n\n<p>The Malaysian <strong>Medical\nDevice Authority (MDA)<\/strong> has published a <strong>guideline\n<\/strong>on <strong>masks <\/strong>for <strong>medical use, <\/strong>specifying the requirements regulated by the <strong>Medical Device Act<\/strong> <strong>(Act 737).<\/strong><\/p>\n\n\n\n<p>MDA does not apply to\nnon-medical masks and respirators, which are classified, instead, as Personal\nProtective Equipment (PPE) and they are not regulated by the MDA.<\/p>\n\n\n\n<p>In the guide, MDA focuses on the performance,\nlabelling and registration requirements and it lists two types of masks for\nmedical use, which are regulated by the Medical Device Act and shall comply\nwith the pre-registration requirements:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>procedural mask<\/strong><strong> <\/strong>used to reduce the risk of spreading\ninfections, when for\nexample patients are in isolation (sterile environments, first aid, intensive\ntherapy, etc\u2026).<\/li><li><strong>surgical mask<\/strong> used inside the operating room or in other\nsterile areas to protect the patient\u2019s environment from infection and who wears\nit from potentially contaminated liquid splashes. <strong><\/strong><\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Are you ready to market your device in the Philippines, Vietnam, Malaysia?<\/strong><\/h2>\n\n\n\n<p>If you want more information or you are interested in <a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">registering<\/a> your Medical Device in South East Asian Countries, <a href=\"mailto:sales@thema-group.it\">contact us<\/a><strong> <\/strong>for a consultancy!<\/p>\n\n\n\n<p><em>Sources:<\/em><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/www.fda.gov.ph\/wp-content\/uploads\/2021\/01\/FDA-Circular-No.2021-001.pdf\" target=\"_blank\">FDA Philippines Circular 2021-001<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/thuvienphapluat.vn\/en\/index.aspx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Ministry of Health of Vietnam <\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/portal.mda.gov.my\/documents\/guidance-documents\/1547-mdagd0033-medical-face-mask-guidelines-60-60-18jan2021-2\/file.html\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Malesia Guidance Document medical face mask and respirator<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Below there are the latest news on the regulatory updates of Medical Devices in some South-East Asian markets of particular relevance  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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-17339","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>SOUTH EAST ASIAN: Medical Devices regulatory updates<\/title>\n<meta name=\"description\" content=\"Latest 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