{"id":17767,"date":"2021-03-25T10:48:54","date_gmt":"2021-03-25T09:48:54","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17767"},"modified":"2023-01-24T14:59:01","modified_gmt":"2023-01-24T13:59:01","slug":"mohfw-proposes-astm-standards-compliance-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/03\/25\/mohfw-proposes-astm-standards-compliance-medical-devices\/","title":{"rendered":"INDIA: Ministry proposes ASTM standards for demonstrating compliance with Medical Devices"},"content":{"rendered":"\n<p>In the notification\npublished on 5 February 2021 in the Official Gazette, <strong>the India\u2019s Ministry\nof Health and Family Welfare (MoHFW)<\/strong> proposed to recognise <strong>methods<\/strong> and <strong>standards<\/strong> <strong>of the American Society for Testing and Materials\nInternational (ASTM International)<\/strong> to access the compliance of Medical Devices\nwith safety requirements, in order to facilitate the entry of devices on the\nIndian market. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/03\/india-ministero-metodi-astm-conformit\u00e0-dispositivi-medici-1024x536.jpg\" alt=\"Ministry proposes ASTM standards for demonstrating compliance with Medical Devices\" class=\"wp-image-17737\"\/><figcaption>Ministry proposes ASTM standards for demonstrating compliance <br>with Medical Devices<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What are\nthe American Standard Test Methods (ASTM)?<\/strong><\/h2>\n\n\n\n<p>The American Society for Testing and Materials International is a US\nstandardization body recognized worldwide for the development and supply of <strong>international standards<\/strong>. ASTM methods\nand standards are used to <strong>improve\nproduct quality<\/strong>, increase and <strong>ensure<\/strong>\n<strong>security, facilitate access to trade <\/strong>and\nmarkets<strong>. <\/strong>&nbsp;<\/p>\n\n\n\n<p>There are several ASTM\nstandards for Medical Devices. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Are there any changes to the Medical Devices Rules?<\/strong><\/h2>\n\n\n\n<p>The notification published by the India\u2019s Ministry of Health and Family\nWelfare could make <strong>changes<\/strong> to the <strong>Medical\nDevices Rules <\/strong>Indian Regulation,\nin order to allow companies in the field of Medical Devices to use ASTM\nstandards to demonstrate the conformity of the products. At the moment, indeed,\nthe regulation in force in India recognizes only the international ISO and IEC\ndevice standards. <\/p>\n\n\n\n<p>If the Ministry\u2019s proposal to recognize the American Standard Test\nMethods (ASTM) will be taken into account and accepted, Manufacturers will have\nthese standards at their disposal to demonstrate the conformity of their\nMedical Devices during the registration process at the Central Drugs Standard\nControl Organization (CDSCO) which is the Indian Regulatory Authority for\npharmaceutical products and Medical Devices. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you want to market your Medical Devices in India in accordance with the regulations?<\/strong><\/h2>\n\n\n\n<p>Thema experts can help you! <a href=\"mailto:sales@thema-group.it\"><strong>Contact us <\/strong><\/a>to plan a consultation! <\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=Njk1Ng==\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Notifica India\u2019s Ministry of Health and Family Welfare (MoHFW)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the notification published on 5 February 2021 in the Official Gazette, the India\u2019s Ministry of Health and Family Welfare (MoHFW)  [&#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-17767","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>INDIA: MoHFW proposes ASTM standards for compliance Medical Devices<\/title>\n<meta name=\"description\" content=\"India\u2019s Ministry of Health and Family Welfare (MoHFW) proposed to recognise American Standard Test Methods to access the compliance of Medical Devices\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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