{"id":15766,"date":"2020-09-03T13:05:20","date_gmt":"2020-09-03T07:35:20","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=15766"},"modified":"2020-09-03T13:05:22","modified_gmt":"2020-09-03T07:35:22","slug":"documents-required-for-medical-device-registration-online","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/documents-required-for-medical-device-registration-online\/","title":{"rendered":"Know the Checklist for Documents Required For Medical Device Registration in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Indian healthcare market is the fastest-growing market for medical products. Manufacturers worldwide are more inclined toward the Indian market due to the high potential for growth and long term profit. In India, medical devices are regulated by The Central Drugs Standard Control Organization.  Being a statutory body, the CDSCO is held accountable for furnishing <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>medical device registration<\/strong><\/a> to the business entities in India. The entities seeking medical device registration needs to fill up an application on the CDSCO SUGUM portal and upload the prescribed documents. In this blog, we will look into Documents required for Medical Device Registration in India.  <\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"659\" height=\"619\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/09\/image-10.png\" alt=\"Medical Device Registration in India\" class=\"wp-image-15777\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/09\/image-10.png 659w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/09\/image-10-300x282.png 300w\" sizes=\"(max-width: 659px) 100vw, 659px\" \/><\/figure><\/div>\n\n\n\n<p><strong><em>Medical devices which seek\nregistration are as follows: <\/em><\/strong><\/p>\n\n\n\n<ul><li>Cochlear implants<\/li><li>Spinal needles <\/li><li>Syringes and needles<\/li><li>Annuloplasty rings<\/li><li>Heart valve<\/li><li>Endotracheal tubes<\/li><li>Surgical sealants<\/li><li>Orthopedic implant <\/li><li>Catheters<\/li><li>Cardiac stents<\/li><\/ul>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/importance-of-a-medical-device-certificate-in-india\/\">What is the Importance of a Medical Device Certificate in India?<\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Documents Required for Medical\nDevice Registration<\/h2>\n\n\n\n<p>Now let&#8217;s talk about\nthe documentation part that you will need to upload on the CDSCO portal for the\nregistration purpose. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 40 <\/h3>\n\n\n\n<p>Form 40 is an\napplication to obtain approval for product distribution in the Indian market.\nIf your product falls under notifies product category, then you would need to\nget register under CDSCO via form 40. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">TR6 Challan <\/h3>\n\n\n\n<p>TR 6 Challan is often\nutilized to address the payment of service tax. It can also be used to pay\ncustoms duty for the imported product. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Schedule D (I) <\/h3>\n\n\n\n<p>Schedule D(I) enclose\nthe details and undertaking need to be filled by the manufacturer or agent via\napplication form for a registration certificate. The format must be\nappropriately filled in for application in Form 40. The applicant should\nmaintain the confidentiality of such information and must deliver the content\nin an encrypted format. <\/p>\n\n\n\n<p>Schedule D(I) seeks\nthe following particulars from the applicant willing to obtain a registration\ncertificate. <\/p>\n\n\n\n<ul><li>Details\nof the manufacturer and its manufacturing facilities. <\/li><li>Details\nof the drug that is produced at the facility along with existing certificates. <\/li><li>Undertaking\nto declaration <\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Declaration of conformity <\/h3>\n\n\n\n<p>A declaration of\nconformity is a sort of legal document that states a product (from the\nelectronic category) meets the regulations laid down by the statutory body,\nsuch as CE, to assure safety.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Post-market surveillance (PMS)\nreport <\/h3>\n\n\n\n<p>Post-market\nsurveillance (PMS) report is a general assessment report enclosing past data\nthat help to depict complaint trend for specific medical equipment. Such a\nreport can help the manufacturers to overcome loose ends of products that are\nlikely to overshadow its functionality in one way or another. It should be kept\nin mind that PMS is prepared against the existing products that were already\nsold and serving clients from different regions.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Plant master file<\/h3>\n\n\n\n<p>The plant master file\nis drafted by the manufacturer, and it encloses details regarding quality\nmanagement policies, site activities, quality control, and operation. It should\nbe kept in mind that the Plant master file should be site-specific, and it\nshould contain information that exists in the plant. Thus, such a file should\nbe confined around information regarding manufacturing practices and GMP related\nactivities.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Free Sale Certificate <\/h3>\n\n\n\n<p>In India, the free\nsale certificate is issued by State licensing authority, and its purpose is to\nease out the process of exporting the drug to the overseas country. A free sale\ncertificate is a mandatory certification for medical device manufacturers who\nwish to cater to the global market. A free sale certificate gives the\nimplications that the product is safe to use, and it is already available in\nthe country of export. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Device master file <\/h3>\n\n\n\n<p>A device master file encloses the proprietary data regarding the component, material, or manufacturing process. The proprietary data doesn&#8217;t follow a prescribed format as it could vary accordingly as per the type of product or components. A typical device master file encloses test results, comparative analysis, toxicity test results, and <strong><em>biocompatibility<\/em><\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Biocompatibility\"><strong><em>[1]<\/em><\/strong><\/a><\/sup> of the component and the material used in equipment. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ISO 13485 certificate<\/h3>\n\n\n\n<p>ISO 13485 is a\nglobally recognized certification that serves the medical device industry. &nbsp;ISO 13485:2016 illustrates several\nrequirements for a QMS that can be used by a manufacturer engaged with the\nstages of the life-cycle of the medical device. The standard also encompasses\nareas like design, development, manufacturing, storage, installation,\nservicing, and decommissioning. The supplier of medical devices can voluntarily\nopt for this standard to improve their market presence. The standard exhibits\nthe manufacturer&#8217;s ability to meet the regulatory requirements consistently. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Power of Attorney <\/h3>\n\n\n\n<p>A power\nof attorney is a legal document that allows the property\u2019s owner to transfer\nits legal power to another person, aka agent. The agent who obtains the POA\ncould have the legal authority for decision making in relation to the\nprincipal&#8217;s property, finances, or medical care. A power of attorney is more\nlikely to use in a condition when the property owner is not available for any\nreason to sign the legal document. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">CE design certificate <\/h3>\n\n\n\n<p>CE\ndesign certification is usually availed by the manufacturers whose product\nfalls under the EC\/EU directives category. The medical product seeking CE mark\nneeds to conform to the design requirement of such directives. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Other regulatory certificates <\/h3>\n\n\n\n<p>The\nmanufacturer can club other product certifications furnished by the local\nauthorities as well with the aforesaid documents. It could help the authority\nto speed up the registration process. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Illustrations on Documents Arrangements<\/h3>\n\n\n\n<p>Upon arranging\naforesaid documents, head over to the CDSCO SUGUM portal and file the application\nin Form 8. Once you fill the application successfully, upload the softcopy of\nthe aforementioned document on the portal. The authority usually takes a couple\nof months validates the submitted credentials. It should be noted that the\nregistration certificate for medical devices remains valid for three years, and\nit should be renewed within six months before the expiration date. The overseas\nmanufacturers who have FDA approval for their product can use such registration\nto leverage their product&#8217;s authenticity. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n\n\n<p>That&#8217;s all about the Documents required for Medical Device Registration in India. If you have a second thought on this topic, kindly let us know through the comment section. We would value your participation and try to overcome your doubt through professional advice. The <a href=\"https:\/\/corpbiz.io\/\"><strong>CorpBiz<\/strong><\/a> is a highly valued destination for business entities and individuals looking to establish a new India startup. We help our clients obtain mandatory licenses to run the business and help them keep up with ever-evolving compliances. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/registration-process-for-medical-devices-in-india\/\">A Step by Step guide for Registration Process for Medical Devices in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Indian healthcare market is the fastest-growing market for medical products. Manufacturers worldwide are more inclined toward the Indian market due to the high potential for growth and long term profit. In India, medical devices are regulated by The Central Drugs Standard Control Organization. Being a statutory body, the CDSCO is held accountable for furnishing [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":15776,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[956],"acf":{"service_id":"385"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":13829,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/15766"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=15766"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/15766\/revisions"}],"predecessor-version":[{"id":15778,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/15766\/revisions\/15778"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/15776"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=15766"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=15766"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=15766"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}