{"id":74,"date":"2025-01-25T14:06:13","date_gmt":"2025-01-25T14:06:13","guid":{"rendered":"https:\/\/www.dueranconsultancy.com\/blog\/?p=74"},"modified":"2025-08-05T06:59:19","modified_gmt":"2025-08-05T06:59:19","slug":"what-is-non-conviction-certificate","status":"publish","type":"post","link":"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/","title":{"rendered":"What Is a Non-Conviction Certificate (NCC) by CDSCO?[Steps to Obtain]"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Medical device manufacturers must have a crystal-clear record of activity. If your medical devices malfunction, the consequences on the lives of innocent people are disastrous. This is why obtaining a non-conviction certificate is crucial. <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">This certificate verifies that you have not been convicted of any mishaps related to substandard quality of devices. As a result, it is proof of your regulatory compliance. In this post, we&#8217;ll explain what is a non-conviction certificate in detail.<\/span><\/p>\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\" style=\"cursor:inherit\">Table of 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 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#What_Is_a_Non-Conviction_Certificate\" >What Is a Non-Conviction Certificate?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#What_Is_the_Use_of_a_Non-Conviction_Certificate\" >What Is the Use of a Non-Conviction Certificate?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#Who_Can_Apply_for_a_Non-Conviction_Certificate_%E2%80%93_Eligibility_Criteria\" >Who Can Apply for a Non-Conviction Certificate &#8211; Eligibility Criteria<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#How_Do_You_Obtain_Non-Conviction_Certificate_%E2%80%93_Application_Process\" >How Do You Obtain Non-Conviction Certificate &#8211; Application Process?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#1_Document_Collection\" >1. Document Collection<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#2_Application_Submission\" >2. Application Submission<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#3_Review_and_Issuance\" >3. Review and Issuance<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#How_Long_Does_It_Take_to_Get_a_Non-Conviction_Certificate_from_Licensing_Authorities\" >How Long Does It Take to Get a Non-Conviction Certificate from Licensing Authorities?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#What_Happens_If_Your_Application_for_a_Non-Conviction_Certificate_Is_Rejected\" >What Happens If Your Application for a Non-Conviction Certificate Is Rejected?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#Specific_Offenses_Related_to_Medical_Devices_That_Are_Considered_When_Issuing_the_NCC\" >Specific Offenses Related to Medical Devices That Are Considered When Issuing the NCC?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.dueranconsultancy.com\/blog\/what-is-non-conviction-certificate\/#Concluding_Words\" >Concluding Words:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_Is_a_Non-Conviction_Certificate\"><\/span><b>What Is a Non-Conviction Certificate?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The non-conviction certificate certifies that you have a valid medical device license and have not been convicted under the Medical Devices Rules 2017 for the following reasons:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-weight: 400;\">Deaths or injuries related to your medical devices.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Reported malfunctions or quality standard violations.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Instances of your devices violating the quality standards.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The non-conviction certificate is issued by the respective licensing authority, which has issued the manufacturing license for a particular device. After you receive the certificate, its validity is for one year.<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_Is_the_Use_of_a_Non-Conviction_Certificate\"><\/span><b>What Is the Use of a Non-Conviction Certificate?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Tenders and procurement processes in India and international markets require a non-conviction certificate. It shows that your medical device company is fully compliant. In addition, the certificate indicates that you are successful in manufacturing medical devices that meet regulatory standards. It is essential for maintaining market integrity. The NCC also enhances your market reputation, which allows potential clients and partners to view your services in a positive light.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Who_Can_Apply_for_a_Non-Conviction_Certificate_%E2%80%93_Eligibility_Criteria\"><\/span><b>Who Can Apply for a Non-Conviction Certificate &#8211; Eligibility Criteria<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The application process for NCC is open to Indian companies with a valid medical device manufacturing and\/or import license. Also, you should not have any track record of getting caught in an offense related to the quality and performance of your devices under the Medical Devices Rules 2017.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_Do_You_Obtain_Non-Conviction_Certificate_%E2%80%93_Application_Process\"><\/span><b>How Do You Obtain Non-Conviction Certificate &#8211; Application Process?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The application and approval of NCC follow three major steps, which include document collection, application submission, and review by the licensing authority.<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"1_Document_Collection\"><\/span><b>1. Document Collection<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">To apply for the NCC, you need a couple of documents. These include:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-weight: 400;\">A covering letter addressed to the State Licensing Authority (SLA) or Central Licensing Authority (CLA). The cover letter should include the intent of the application and mention the documents you are submitting.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">A list of devices that require NCC.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Authorization of the signatory of the form.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">A copy of your licenses or renewal certificate held and retention certificate wherever applicable.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">A signed legal declaration on a Rs. 100 notarized stamp paper stating that no legal action has been taken against the firm.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">A prior NCC, if applicable.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"2_Application_Submission\"><\/span><b>2. Application Submission<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Find the application form for the non-conviction certificate on the <\/span><a href=\"http:\/\/www.cdscomdonline.gov.in\/\" target=\"_Blank\" rel=\"nofollow noopener\"><span style=\"font-weight: 400;\">www.cdscomdonline.gov.in<\/span><\/a> <span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\"> website. Use this link to access the form and fill it out. After that, attach the relevant documents and submit the application to the Authorities.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"3_Review_and_Issuance\"><\/span><b>3. Review and Issuance<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Your application is reviewed by the designated licensing authority. If they do not find any convictions, an NCC is issued. It will be valid for a year from the date of issuance.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"How_Long_Does_It_Take_to_Get_a_Non-Conviction_Certificate_from_Licensing_Authorities\"><\/span><b>How Long Does It Take to Get a Non-Conviction Certificate from Licensing Authorities?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The process of obtaining an NCC from <\/span><span style=\"font-weight: 400;\">Licensing Authorities<\/span><span style=\"font-weight: 400;\"> usually takes a few weeks. The licensing authority can take up to 15 days to review the process. This period varied according to the workload on the authority.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">After checking and analyzing your application, the licensing authority issues the NCC within a few weeks. So, overall, you may need to wait for four weeks to get NCC.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"What_Happens_If_Your_Application_for_a_Non-Conviction_Certificate_Is_Rejected\"><\/span><b>What Happens If Your Application for a Non-Conviction Certificate Is Rejected?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">You must understand the reasons for the licensing authority&#8217;s rejection of your NCC application and take the necessary steps. Usually, the rejection happens because of the following reasons:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-weight: 400;\">Submission of invalid documents.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">A violation of rules related to medical device manufacturing negatively impacts your application&#8217;s status.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">You can find the status of your application by logging into the medical device sugam portal. Click <\/span><b>Menu<\/b><span style=\"font-weight: 400;\">, followed by <\/span><b>Form Submission<\/b><span style=\"font-weight: 400;\">, and then <\/span><b>submit applications<\/b><span style=\"font-weight: 400;\">. If you find your application here, it means you need to rectify the issues with it. This is why working with experienced CDSCO or FDA registration consultants is crucial. It enables you to navigate the complexities in document preparation, submission, and getting approval.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Specific_Offenses_Related_to_Medical_Devices_That_Are_Considered_When_Issuing_the_NCC\"><\/span><strong>Specific Offenses Related to Medical Devices That Are Considered When Issuing the NCC?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Before applying for NCC, you must know the compliance laws related to medical devices. It will increase your chances of application approval. According to CDSCO, the following regulations are critical for medical device manufacturing in India.<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-weight: 400;\">The medical device should conform to the standards of the Bureau of Indian Standards set up by the Bureau of Indian Standards Act, 1985.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">If no relevant standards are specified, the medical device should be compliant with the International Organisation for Standardisation (ISO) or the standards set by a validated manufacturer.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Manufacturing counterfeit and mislabelled devices are strictly prohibited.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>You can find detailed guidelines for <a href=\"https:\/\/www.services.bis.gov.in\/php\/BIS_2.0\/bisconnect\/get_is_list_by_category_id\/12\" target=\"_Blank\" rel=\"nofollow noopener\">medical devices by the BIS<\/a> here.<\/strong><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Concluding_Words\"><\/span><strong>Concluding Words:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">A valid Non-Conviction Certificate for manufacturers and <a href=\"https:\/\/www.dueranconsultancy.com\/medical-device-licenses\">medical device importers<\/a> shows their commitment to safety and compliance. It strengthens your reputation in the market and boosts trust in your services. If you want to speed up the process of getting this certificate, working with trusted medical device registration consultants is crucial. <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">They streamline your application process and provide support throughout until you receive the certificate. Contact Dueran Consultant today for a free consultation on obtaining an NCC.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical device manufacturers must have a crystal-clear record of activity. If your medical devices malfunction, the consequences on the lives<\/p>\n","protected":false},"author":1,"featured_media":75,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[596],"tags":[30,29],"class_list":["post-74","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-certificate","tag-non-conviction-certificate","tag-what-is-non-conviction-certificate"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is Non Conviction Certificate? [ Get In-Depth Info]<\/title>\n<meta name=\"description\" content=\"Know what is the non-conviction certificate? 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