{"id":15366,"date":"2026-06-17T14:25:18","date_gmt":"2026-06-17T08:55:18","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=15366"},"modified":"2026-06-17T14:25:18","modified_gmt":"2026-06-17T08:55:18","slug":"standard-operating-procedure","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/dz-en\/standard-operating-procedure\/","title":{"rendered":"Standard Operating Procedure for Testing Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"15366\" class=\"elementor elementor-15366\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3a32e968 e-flex e-con-boxed e-con e-parent\" data-id=\"3a32e968\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-710c9a94 elementor-widget elementor-widget-heading\" data-id=\"710c9a94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Standard Operating Procedure for Testing Medical Devices<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-46af9c93 e-flex e-con-boxed e-con e-parent\" data-id=\"46af9c93\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-70047ba3 e-con-full e-flex e-con e-child\" data-id=\"70047ba3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20484dbb elementor-widget elementor-widget-text-editor\" data-id=\"20484dbb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">For the improvement of the medical device sector, the government is making efforts and updating guidelines from time to time. It is hard for the manufacturer\/service provider to maintain all the records of the new updates and work as per the new regulations. To address this situation we provide regulatory services and help our clients to move ahead with their projects. Recently the Government of India issued new guidelines about standard operating procedures (SoPs) for testing medical devices, which will strengthen the infrastructure for the approval of medical devices. Currently with no mandatory regulation on drugs and pharmaceutical lines for taking samples and conducting audits, all states have developed laboratories as per their requirement and abilities. In India, we have different categories of medical devices and they may require different types of testing infrastructure. The meeting was held under the chairmanship of the secretary of the Department of Pharmaceuticals (Dop) to prepare the roadmap to improve testing infrastructure to enable a smoother transition to medical device licensing. For the submission of the report, a month\u2019s timeframe is given to the committee.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-676b9b25 e-con-full e-flex e-con e-child\" data-id=\"676b9b25\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-6fa7a0ca e-con-full e-flex e-con e-child\" data-id=\"6fa7a0ca\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2044ded3 elementor-widget elementor-widget-heading\" data-id=\"2044ded3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Regulatory Excellence for Global Medical Device Markets\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-56599ccf elementor-widget elementor-widget-wpforms\" data-id=\"56599ccf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/dz-en\/wp-json\/wp\/v2\/posts\/15366\" data-token=\"a8ad86ac67e8a3f4888d7318f23568b3\" data-token-time=\"1781693854\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Name Text Paragraph<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/15366\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4e7fb2ae e-flex e-con-boxed e-con e-parent\" data-id=\"4e7fb2ae\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-109059b9 elementor-widget elementor-widget-text-editor\" data-id=\"109059b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Standard operating procedures (SoPs) are needed for the assurance that quality standards are met by the manufacturer.\u00a0 We are helping the manufacturer to develop their quality management system as per the requirement of\u00a0 <\/span><span style=\"font-weight: 400;\">ISO 15378 certification<\/span><span style=\"font-weight: 400;\">. To complete the procedure for this <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">contact us<\/span><\/a><span style=\"font-weight: 400;\"> or you can <\/span><a href=\"https:\/\/api.whatsapp.com\/send\/?phone=919370283428&amp;text=Hi%2C+I+require+consultancy+for+medical+device.&amp;app_absent=0\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">WhatsApp us<\/span><\/a><span style=\"font-weight: 400;\"> your requirements.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Currently, there is a minimum mandatory requirement for state regulator on how many samples they can take and verify Once the medical device regulation comes into force testing of medical devices will become mandatory, so the prime task for the working committee is to identify which facilities within the government and which independent ones are available in the country to test medical devices,\u201d the official said.<\/span><\/p><p><span style=\"font-weight: 400;\">\u201cThe committee will also tell us which category of product which lab may be able to test. We called on several stakeholders from the Central Drugs Standard Control Organization (CDSCO), industry, DoP, and NIPER to do this exercise and give their report,\u201d the official said.\u201d<\/span><\/p><p><span style=\"font-weight: 400;\">As per the latest update from CDSCO manufacturers of low-risk devices (Class A &amp; Class B) were required to undergo a mandatory registration regime until September 2022 and device manufacturers of high-risk medical devices (Class C &amp; D) have been invited to do so until September 2023. After the mandatory registration period, these classes will respectively move to the licensing regime.<\/span><\/p><p><span style=\"font-weight: 400;\">The goal is to prepare the industry for an easy transition regulatory regime. The tests had been commissioned by way of the CDSCO according to the standards; similarly, random samples also are in development. This workout will create a permitting surroundings and fill the existing gaps.<\/span><\/p><p><span style=\"font-weight: 400;\">Operon strategist <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device consultancy<\/span><\/a><span style=\"font-weight: 400;\"> launched the newsletter \u201cReguveda-Your guide for regulatory updates\u201d to keep you updated with new regulations. Don\u2019t forget to subscribe to our <\/span><a href=\"https:\/\/operonstrategist.com\/newsletter\/\"><span style=\"font-weight: 400;\">Newsletter.<\/span><\/a><\/p><p><span style=\"font-weight: 400;\">References:<\/span><\/p><p><a href=\"https:\/\/www.livemint.com\/news\/india\/india-to-prepare-detailed-guidelines-sops-for-testing-medical-devices-11653595176976.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.livemint.com\/news\/india\/india-to-prepare-detailed-guidelines-sops-for-testing-medical-devices-11653595176976.html<\/span><\/a><\/p><p><br \/><br \/><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>For the improvement of the medical device sector, the government is making efforts and updating guidelines from time to time. It is hard for the manufacturer\/service provider to maintain all the records of the new updates and work as per the new regulations. To address this situation we provide regulatory services and help our clients [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":15509,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[57],"tags":[],"class_list":["post-15366","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco-category"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/15366","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/comments?post=15366"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/15366\/revisions"}],"predecessor-version":[{"id":15510,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/15366\/revisions\/15510"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media\/15509"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media?parent=15366"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/categories?post=15366"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/tags?post=15366"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}