{"id":33985,"date":"2026-01-09T11:27:38","date_gmt":"2026-01-09T05:57:38","guid":{"rendered":"https:\/\/www.legalraasta.com\/blog\/?p=33985"},"modified":"2026-04-03T17:11:00","modified_gmt":"2026-04-03T11:41:00","slug":"cdsco-medical-device-license-india","status":"publish","type":"post","link":"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/","title":{"rendered":"CDSCO Medical Device License in India: Complete Guide"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In India, CDSCO, which stands for Central Drugs Standard Control Organization, is one of the most recognized national regulatory authorities. This authority focuses on drugs, cosmetics, and medical device management. It is further responsible for issuing the license to the respective service. In India, <\/span><strong>CDSCO <\/strong><a href=\"https:\/\/www.legalraasta.com\/medical-device-registration\/\">medical device registration<\/a><span style=\"font-weight: 400\"> is a legal authorization to regulate the manufacturing, selling, or stocking of medical devices. Under the Medical Devices Rules, 2017, the CDSCO Medical Device License in India is compulsory to meet the safety, quality, and performance standards. Licensing ensures it is safe to use for public health and will not harm. Still looking for the registration process, documentation, and timeline? Explore more in the next section.<\/span><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_73 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\">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.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#1_What_is_a_CDSCO_Medical_Device_License_in_India\" title=\"1. What is a CDSCO Medical Device License in India?\">1. What is a CDSCO Medical Device License in India?<\/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.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#2_Why_is_a_Medical_Device_License_Mandatory_in_India\" title=\"2. Why is a Medical Device License Mandatory in India?\">2. Why is a Medical Device License Mandatory in India?<\/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.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#3_Who_Needs_a_Medical_Device_License_in_India\" title=\"3. Who Needs a Medical Device License in India?\">3. Who Needs a Medical Device License in India?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#4_Medical_Device_Classification_in_India_Class_A_B_C_D\" title=\"4. Medical Device Classification in India (Class A, B, C, D)\">4. Medical Device Classification in India (Class A, B, C, D)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#5_Types_of_Medical_Device_Licenses_in_India\" title=\"5. Types of Medical Device Licenses in India\">5. Types of Medical Device Licenses in India<\/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.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#6_Eligibility_Criteria_for_Medical_Device_License_Registration\" title=\"6. Eligibility Criteria for Medical Device License Registration\">6. Eligibility Criteria for Medical Device License Registration<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#7_Documents_Required_for_Medical_Device_License_Checklist\" title=\"7. Documents Required for Medical Device License (Checklist)\">7. Documents Required for Medical Device License (Checklist)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#8_Medical_Device_License_Fees_in_India\" title=\"8. Medical Device License Fees in India\">8. Medical Device License Fees in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#9_Step-by-Step_Process_to_Get_Medical_Device_License_in_India\" title=\"9. Step-by-Step Process to Get Medical Device License in India\">9. Step-by-Step Process to Get Medical Device License in India<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#10_How_to_Apply_Online_for_Medical_Device_License_CDSCOSUGAM_Portal\" title=\"10. How to Apply Online for Medical Device License (CDSCO\/SUGAM Portal)\">10. How to Apply Online for Medical Device License (CDSCO\/SUGAM Portal)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#11_Timeline_for_Medical_Device_License_Approval_How_Long_It_Takes\" title=\"11. Timeline for Medical Device License Approval (How Long It Takes)\">11. Timeline for Medical Device License Approval (How Long It Takes)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#12_Inspection_Verification_Process_What_to_Expect\" title=\"12. Inspection &amp; Verification Process (What to Expect)\">12. Inspection &amp; Verification Process (What to Expect)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#13_Validity_Renewal_Retention_of_Medical_Device_License\" title=\"13. Validity, Renewal &amp; Retention of Medical Device License\">13. Validity, Renewal &amp; Retention of Medical Device License<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#14_AmendmentChanges_in_Medical_Device_License_Company_Details_Address_Product_Manufacturing_Site\" title=\"14. Amendment\/Changes in Medical Device License (Company Details, Address, Product, Manufacturing Site)\">14. Amendment\/Changes in Medical Device License (Company Details, Address, Product, Manufacturing Site)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#15_Common_Reasons_for_DelayRejection_and_How_to_Avoid_Them\" title=\"15. Common Reasons for Delay\/Rejection (and How to Avoid Them)\">15. Common Reasons for Delay\/Rejection (and How to Avoid Them)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#16_Penalties_for_ManufacturingImportingSelling_Medical_Devices_Without_a_License\" title=\"16. Penalties for Manufacturing\/Importing\/Selling Medical Devices Without a License\">16. Penalties for Manufacturing\/Importing\/Selling Medical Devices Without a License<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#17_Why_Choose_LegalRaasta_for_Medical_Device_License_Registration\" title=\"17. Why Choose LegalRaasta for Medical Device License Registration?\">17. Why Choose LegalRaasta for Medical Device License Registration?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#18_Frequently_Asked_Questions_FAQs\" title=\"18. Frequently Asked Questions (FAQs)\">18. Frequently Asked Questions (FAQs)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.legalraasta.com\/blog\/cdsco-medical-device-license-india\/#19_Final_Thoughts_CDSCO_Medical_Device_Registration_for_Manufacturing_or_Importing\" title=\"19. Final Thoughts | CDSCO Medical Device Registration for Manufacturing or Importing\">19. Final Thoughts | CDSCO Medical Device Registration for Manufacturing or Importing<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"1_What_is_a_CDSCO_Medical_Device_License_in_India\"><\/span><b>1. What is a CDSCO Medical Device License in India?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">A Medical Device License in India is a primary legal authorization from the Central Drugs Standard Control Organization (CDSCO), the national regulatory body. It is required for manufacturing, importing, selling, or distributing medical devices in the respective places. It further ensures that the registered devices meet safety and quality standards before being presented in markets. Meanwhile, for different work purposes, different licenses are required (like the Import License, Manufacturing License, and MD 42). One needs to obtain a device risk (Class A, B, C, D) and activity license from the Government of India before operating legally in India to verify the quality of equipment and to preserve the Indian public health.<\/span><\/p>\n<h2 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"2_Why_is_a_Medical_Device_License_Mandatory_in_India\"><\/span><b>2. Why is a Medical Device License Mandatory in India?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">According to the governing law, medical devices sold or being sold in India must register their medical device license with the CDSCO to operate legally in India. Through the registration, the governing authority, like CDSCO, gets access to manage the device&#8217;s safety, quality, and performance. Before the market presentation, the devices are tested to ensure quality. Here are the key reasons why licensing is a prerequisite:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Assuring Safety\/Quality: <\/b><span style=\"font-weight: 400\">Medical devices must be registered to ensure their safety and effectiveness. The Medical Device License ensures that only safe, effective, and commercially viable Medical Devices are manufactured in India and provides a guarantee to consumers that they cannot purchase unsafe, counterfeit, or defective devices. Furthermore, it is required that all manufacturers of Medical Devices registered with the CDSCO adhere to all other legislative requirements in the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\">Drugs and Cosmetics Act of 1940<\/a>, as well as the Medical Devices Rules of 2017.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Risk-based Classification of Devices: <\/b><span style=\"font-weight: 400\">All devices are classified into A, B, C, and D. However, it depends on how risky they are. Therefore, the regulatory requirements for licensing differ depending on the level of risk associated with the device, with higher-risk devices subjected to more rigorous regulation.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Legal authorization:<\/b><span style=\"font-weight: 400\"> Before operating the medical devices in India, the manufacturers and importers need to first obtain the legal permission from the national controlling authority (CDSCO). Registration gives them the market access and legal authorization to operate devices. It is mainly required by hospitals and other organizations that procure devices.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Credibility and trust: <\/b><span style=\"font-weight: 400\">Manufacturers of devices will have increased credibility and will provide healthcare providers with assurance that the devices comply with established standards.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Centralized Regulatory Supervision: <\/b><span style=\"font-weight: 400\">The national regulatory authority oversees the imported and high-risk medical devices through real-time tracking. Meanwhile, state licensing authorities provide for the manufacture and sale of low-risk medical devices.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>Don\u2019t Miss This &#8211;<\/b> <a href=\"https:\/\/www.legalraasta.com\/blog\/medical-license-in-india-apply-online\/\"><span style=\"font-weight: 400\">How Can You Apply for a Medical License in India? Registration Process &amp; Eligibility<\/span><\/a><\/p>\n<h2 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"3_Who_Needs_a_Medical_Device_License_in_India\"><\/span><b>3. Who Needs a Medical Device License in India?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">CDSCO registration for medical devices is mandatory for those who are planning to import, manufacture, sell, stock, or distribute medical devices in India. The type of license requirement depends on the device risk, e.g., Class A, B, C, or D. Meanwhile, registration is mandatory for:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Domestic manufacturers who manufacture the devices in their own facility.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Importers who import all risk device classes (A, B, C, and D). License MD-14\/MD-15 is required.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sellers or distributors who sell, stock, exhibit, or distribute medical devices are required to obtain permission from the State Authority (SA).\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Foreign medical device companies are also eligible to work through authorized agents or Indian subsidiaries to register and get licenses.<\/span><\/li>\n<\/ul>\n<h3 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"4_Medical_Device_Classification_in_India_Class_A_B_C_D\"><\/span><b>4. Medical Device Classification in India (Class A, B, C, D)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Medical devices are classified into four risk-based categories. These are categorized as<\/span><\/p>\n<table style=\"width: 100%\">\n<tbody>\n<tr>\n<td style=\"width: 8.10157%\">\n<p><span style=\"font-size: 10pt\"><b>A\u00a0 Class<\/b><\/span><\/p>\n<\/td>\n<td style=\"width: 90.931%\">\n<p><span style=\"font-weight: 400\">Possesses minor potential for harm and can be contacted directly to the skin. For example, surgical masks, examination gloves, bandages, and tongue depressors.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 8.10157%\">\n<p><span style=\"font-size: 10pt\"><b>B <\/b><\/span><b style=\"font-size: 10pt;font-family: inherit\">Class<\/b><\/p>\n<\/td>\n<td style=\"width: 90.931%\">\n<p><span style=\"font-weight: 400\">Have low to moderate risk, are non-invasive, but contact mucous membranes, or are invasive for short durations. Examples are hypodermic needles, suction equipment, blood pressure monitors, and nebulizers.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 8.10157%\">\n<p><span style=\"font-size: 10pt\"><b>C\u00a0 Class<\/b><\/span><\/p>\n<\/td>\n<td style=\"width: 90.931%\">\n<p><span style=\"font-weight: 400\">Possibility of moderate to high risk, invasive, prolonged contact, or use during serious conditions. Examples are orthopedic implants, coronary stents, ventilators, some catheters, and breast implants.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 8.10157%\">\n<p><span style=\"font-size: 10pt\"><b>D Class<\/b><\/span><\/p>\n<\/td>\n<td style=\"width: 90.931%\">\n<p><span style=\"font-weight: 400\">High risk possibility, life supporting, implantable, or critical for patient health. Examples are heart valves, pacemakers, implantable defibrillators, etc.\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p style=\"text-align: justify\"><b>Note: <\/b><span style=\"font-weight: 400\">For classes A and B, the regulatory management is the state authorities. While Classes C and D are operated by the central authority, CDSCO.\u00a0<\/span><\/p>\n<h3 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"5_Types_of_Medical_Device_Licenses_in_India\"><\/span><b>5. Types of Medical Device Licenses in India<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The different medical licenses in India are handled by the different licensing authorities (State Licensing Authority and Central Licensing Authority). In detail:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Manufacturing License: <\/b><span style=\"font-weight: 400\">For Class A and B, the medical device manufacturing license is issued by the State Licensing Authority (SLA). Meanwhile, for Classes C and D, the licensing issuing authority is the Central Licensing Authority (CLA-CDSCO).<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Import License:<\/b><span style=\"font-weight: 400\"> For all risk classes like A, B, C, and D, the medical device import license is issued by the Central Licensing Authority, CDSCO, in the form MD-15.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Sale License: T<\/b><span style=\"font-weight: 400\">he State Licensing Authority (SLA) is responsible for approving all risk classes in India.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Test License: <\/b><span style=\"font-weight: 400\">It is required for legally researching or testing a small quantity of medical devices. The medical device test license is issued in Form MD-13.\u00a0<\/span><\/li>\n<\/ul>\n<h3 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"6_Eligibility_Criteria_for_Medical_Device_License_Registration\"><\/span><b>6. Eligibility Criteria for Medical Device License Registration<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">To meet the requirements for the CDSCO medical device license, the businesses are required to align with all standards. For a license, the primary requirement is to have a registered business (proprietorship, LLP, or Pvt Ltd). Only a pharmacist or a science graduate with relevant experience to supervise operations is eligible. The registered firm must comply with storage standards, which include space, cleanliness, and temperature control if required. Classify all devices into their risk factors (Class A, B, C, and D).\u00a0<\/span><\/p>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"7_Documents_Required_for_Medical_Device_License_Checklist\"><\/span><b>7. Documents Required for Medical Device License (Checklist)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">For fast and hassle-free CDSCO registration for a medical device, multiple documents are required to be attached to the application form. The major documents are required:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">CDSCO\u00a0 application form\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">TR6 challan for payment proof<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Applicant, company, and premises identity and address proof<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Power of attorney is applicable<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>Documents Required for Manufacturing License<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Application form\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Device Master File (DMF) &amp; Plant Master File (PMF)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Quality management system and manufacturing details<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Blueprint of premises and quality certificate<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>For Import License<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Application form<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Manufacturing license from the original country<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Free sale certificate (FSC) from COO<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">CE Certificates &amp; Design Certificates<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Device\/Plant Master Files (DMF\/PMF)<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>For Distribution\/Sale License<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Application form<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Incorporation\/Partnership docs for business proof<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">rent agreement\/property papers for premises proof<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">technical staff for qualification proof, experience letter<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Undertaking for compliance with storage<\/span><\/li>\n<\/ul>\n<h3 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"8_Medical_Device_License_Fees_in_India\"><\/span><b>8. Medical Device License Fees in India<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In India, CDSCO is responsible for managing the medical device license registration fees. The device classifications, type of license, number of sites, device specificity, and regulatory pathway are the key factors that affect the registration fees. Here is the classification to understand the medical device license fees in India:<\/span><\/p>\n<p style=\"text-align: justify\"><b>Manufacturing License (CDSCO)<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Class A &amp; B Devices<\/b><span style=\"font-weight: 400\">: For each manufacturing set need to pay Rs 5,000. For each different medical device, the registration fees are Rs 500.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Class C &amp; D Devices:<\/b><span style=\"font-weight: 400\"> Due to the higher risk class, the manufacturing site fee is Rs 50,000\u00a0 and Rs 1,000 for each distinct medical device.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>Import License (CDSCO)<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">For an import license application with a single site, you need to pay around 1,500 (or INR equivalent). Meanwhile, for the registration certificate, the fee is around USD 1,000 (or INR equivalent).\u00a0<\/span><\/p>\n<h3 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"9_Step-by-Step_Process_to_Get_Medical_Device_License_in_India\"><\/span><b>9. Step-by-Step Process to Get Medical Device License in India<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Being new to the market, it will be tough to navigate the complex medical device license registration process. While multiple documents are required for registration. Here is a complete guide on how to get the\u00a0 license in a short duration with the right direction:<\/span><\/p>\n<p style=\"text-align: justify\"><b>Step 1: Device Classification<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Determine which type of medical devices you are operating based on their risk factors (e.g., Class A, B, C, and D). For a better understanding, utilize the CDSCO guidelines.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Step 2: Navigate the CDSCO Portal<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Make an account on the CDSCO portal SUGAM\u00a0 (cdscoonline.gov.in).<\/span><\/p>\n<p style=\"text-align: justify\"><b>Step 3: Application Process<\/b><\/p>\n<p style=\"text-align: justify\"><b>For Indian Manufacturers<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">An Indian manufacturer must register with the State Licensing Authority (SLA) for Class A\/B. Form MD-3 is the application form, and the license is issued in MD-5. Meanwhile, for the Class C and D medical devices, you must register with the Central Licensing Authority (CLA).\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><b>For Foreign Manufacturers<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">An international manufacturer needs to appoint an Indian Authorized Agent (IAA).\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><b>Step 4: Online Submission &amp; Fees<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">\u00a0To apply to the CDSCO\/SLA, precise procedures must be followed.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Step 5: Review and Inspection<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The manufacturing facility will be inspected on-site by the notified body. The manufacturing facility will be inspected on-site by the notified body.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Step 6: Compliance &amp; Approval<\/b><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The approving authority will respond as soon as possible to the audit findings or questions. The importer will receive a license once all issues have been resolved.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Note:<\/b><span style=\"font-weight: 400\"> Applicant must comply with the Medical Device Regulations, 2017, regarding safety and quality in all instances.<\/span><\/p>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"10_How_to_Apply_Online_for_Medical_Device_License_CDSCOSUGAM_Portal\"><\/span><b>10. How to Apply Online for Medical Device License (CDSCO\/SUGAM Portal)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The SUGAM portal is a single window for CDSCO medical device license registration in India. Before application submission, the importer or manufacturer is first required to register on the portal (https:\/\/www.cdscomdonline.gov.in\/NewMedDev\/Homepage). In short, the government of India has provided a single transparent platform for manufacturing\/import licenses. It further makes tracking easier and converts into paperless transactions. This is how the applicants use the SUGAM portal:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The portal allows manufacturers\/importers to submit digital applications for licenses, NOCs, and registrations.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">After complete registration, the applicants can monitor their application submission status. Including, they can see the pending queries and estimate approval times.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The portal facilitates quick and transparent communication between the applicant and the governing authority, CDSCO.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Things like permissions and certificates can be downloaded directly from the portal.<\/span><\/li>\n<\/ul>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"11_Timeline_for_Medical_Device_License_Approval_How_Long_It_Takes\"><\/span><b>11. Timeline for Medical Device License Approval (How Long It Takes)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The timeline for medical device license approval depends on the device risk class. For the low-risk Class A devices, the minimum timeline for license approval is 2 to 4 months. For higher-risk class devices, such as Class C, the approval timeline is typically 8 to 12 months, while for Class D, 12 to 18 months is more common. But, for all types of devices, the general timeline is 6 to 18 months. Sometimes, CDSCO medical device approval is delayed due to an error in documentation or other factors. The key factors that affect the license approval timeline:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The higher-risk devices, like Class C and D, require more extensive review.\u00a0<\/span><\/li>\n<\/ul>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Approval delayed due to document errors &amp; queries. While restarting after a response potentially takes months.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Due to the involvement of the Subject Expert Committee (SEC) reviews, it takes a significant amount of time.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In the end, 6-9 months is often mentioned as a general timeline, but be prepared for a longer duration, such as up to 18+ months.\u00a0<\/span><\/p>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"12_Inspection_Verification_Process_What_to_Expect\"><\/span><b>12. Inspection &amp; Verification Process (What to Expect)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Inspection and verification are both crucial during the registration process. The verification process involves comprehensive background checks, while a physical inspection is conducted of the premises. Here is what you can expect from both processes:<\/span><\/p>\n<p style=\"text-align: justify\"><b>(CDSCO Verification Process)\u00a0<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The regulatory body or medical board conducts the verification process to ensure the educational qualification. They will confirm your degrees, diplomas, and completion of training programs.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The board will verify whether you have past medical licenses from other states or not. For this, online data will be used to ensure their activeness.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The testing bodies will take the information from the national licensing examinations, like NEXT in India.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">To verify the past disciplinary actions or legal records, the regulatory authorities will check the malpractice database.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The Aadhaar card and passport will be used to identify the Indian citizen.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>Inspection Process (If Required)<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">For those who are registering the new medical clinic in any state of India, whether it is a hospital or a health-related business, an on-site visit will be conducted.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">On-site inspection will be conducted by a drug inspector or health authority officials.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">During the inspection, the inspector will conduct compliance checks to ensure that the registered facility meets minimum standards like infrastructure, hygiene, sanitation, and proper storage of medicines.\u00a0<\/span><\/li>\n<\/ul>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"13_Validity_Renewal_Retention_of_Medical_Device_License\"><\/span><b>13. Validity, Renewal &amp; Retention of Medical Device License<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The Medical Device Rules 2017 highlight that the medical device manufacturing and import license is generally valid perpetually. It means the license remains active as long as manufacturers and importers maintain compliance. But the thing to note is that the retention fee must be paid every five years from the license approval. On the other hand, renewal of the license after a specific timeline is a post-compliance requirement.\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><b>(Complete Renewal Process)<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00a0Pay Retention Charges: Submission for each license and endorsement is mandatory.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Provide Documents: The documents must be complete, clear, and in an accurate format.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Online Submission: Submit the license retention application through the ONDLS (Online National Drug Licensing System) or similar platforms for a state-level license.\u00a0<\/span><\/li>\n<\/ul>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"14_AmendmentChanges_in_Medical_Device_License_Company_Details_Address_Product_Manufacturing_Site\"><\/span><b>14. Amendment\/Changes in Medical Device License (Company Details, Address, Product, Manufacturing Site)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">To make the changes to the current license, it is required to apply to the Central Licensing Authority. Before the amendment application submission, determine whether the change is minor or major. Providing the updated documents is vital, including the Device Master File (DMF) or Plant Master File (PMF). It helps to reflect the changes. With it, a comparative written statement may be required for product-related changes.\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><b>For Specific Changes and Requirements, follow the table:<\/b><\/p>\n<table>\n<tbody>\n<tr>\n<td>\n<p><b>Types of Changes\u00a0<\/b><\/p>\n<\/td>\n<td>\n<p><b>Key Requirements<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p><b>Company Details (e.g., Constitution)<\/b><\/p>\n<\/td>\n<td>\n<p><span style=\"font-weight: 400\">An amendment from proprietorship to partnership\/LLP or from private to public company necessitated a fresh license application under MDR-2017. Must inform the licensing authority within 45 days and start applying changes within 180 days.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p><b>Address (Registered\/Corporate Office)<\/b><\/p>\n<\/td>\n<td>\n<p><span style=\"font-weight: 400\">Apply for an update to the business registration documents and attach the documents for proof of the new address via the online portal.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p><b>Manufacturing Site Address<\/b><\/p>\n<\/td>\n<td>\n<p><span style=\"font-weight: 400\">It is a major amendment; therefore, an on-site inspection will be conducted. The inspector will ensure compliance with the quality management system (QMS). An updated PMF is also mandatory.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p><b>Product (Design, Material, Intended Use, Shelf Life)<\/b><\/p>\n<\/td>\n<td>\n<p><span style=\"font-weight: 400\">Prior approval is necessary; written evidence must be submitted to substantiate the effects upon safety, performance, or quality, including but not limited to an updated DMF, any supporting clinical studies (when applicable), and any biocompatibility studies that were conducted.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td>\n<p><b>Product (Minor changes in manufacturing process, non-primary packaging)<\/b><\/p>\n<\/td>\n<td>\n<p><span style=\"font-weight: 400\">Notification is required no later than 30 days; it does not require prior approval to proceed.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"15_Common_Reasons_for_DelayRejection_and_How_to_Avoid_Them\"><\/span><b>15. Common Reasons for Delay\/Rejection (and How to Avoid Them)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In most cases, the newly registered businesses face the CDSCO medical device license application rejection. There are multiple reasons why the application license is rejected. These common reasons include incomplete documentation, lack of details of clinical\/testing data, wrong device classifications, and non-compliance with the quality management system (QMS). These common challenges can be avoided as follows:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Adopt Regulatory Set Standards<\/b><span style=\"font-weight: 400\">: Develop a sustainable regulatory strategy early in medical device production. It helps to avoid the costly redesign margins.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Document Completeness and Accuracy:<\/b><span style=\"font-weight: 400\"> Before the document&#8217;s final submission, ensure consistency, completeness, and accuracy.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Ensure Device Classification:<\/b><span style=\"font-weight: 400\"> Consult with an expert ot use the official classification tools to verify the risk classes of medical devices.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Consult with an Expert:<\/b><span style=\"font-weight: 400\">\u00a0 To get fast market access or international market engagement, consult with an experienced advisor.\u00a0<\/span><\/li>\n<\/ul>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"16_Penalties_for_ManufacturingImportingSelling_Medical_Devices_Without_a_License\"><\/span><b>16. Penalties for Manufacturing\/Importing\/Selling Medical Devices Without a License<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Under the Drugs and Cosmetics Act, 1940, and MDR 2017, anyone who is a manufacturer, importer, or seller of medical devices in India must register with CDSCO. Operating the equipment without a proper license can lead to serious consequences or even legal penalties. Without a proper license in India, carrying severe penalties including significant fines, imprisonment (can be up to 5 years or more), seizure of stock, and license suspension\/cancellation. In case a medical device causes harm to the patient or death, stricter action will be taken by the controlling authority.\u00a0<\/span><\/p>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"17_Why_Choose_LegalRaasta_for_Medical_Device_License_Registration\"><\/span><b>17. Why Choose LegalRaasta for Medical Device License Registration?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">CDSCO medical device registration online is the primary requirement to get the legal authorization and faster market access. But getting these opportunities becomes easier with LegalRaasta experts. At LegalRaasta, our team&#8217;s expertise streamlines the complex medical device licensing, offering cost-effective service with satisfying discounts. By choosing us for your legal services, you will get professional support, paperless digital services, and reduced costs. Rather than focusing on documentation and registration, it will allow you to focus on innovation, further growth planning, etc. We also provide services for:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">GST registration<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tax filings<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">BIS Certification<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">AD code registration<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">and other legal registration<\/span><\/li>\n<\/ul>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"18_Frequently_Asked_Questions_FAQs\"><\/span><b>18. Frequently Asked Questions (FAQs)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<ol style=\"text-align: justify\">\n<li><b> What is a CDSCO medical device license, and why is it important?<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><b>Ans<\/b><span style=\"font-weight: 400\">. A CDSCO Medical Device License in India is a legal document that clarifies that the registered business has the legal authorization from the Central Drugs Standard Control Organization (CDSCO). It means businesses can import, sell, or distribute medical devices in India without legal action. The medical device license registration is critical to ensure that all equipment meets strict safety, quality, and performance standards.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"2\">\n<li><b> How do I apply on the CDSCO MD Online portal?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><b>Ans<\/b><span style=\"font-weight: 400\">. Now, the process of the CDSCO MD license can be done online via the SUGAM portal.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"3\">\n<li><b> What documents are required for a CDSCO application?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><b>Ans<\/b><span style=\"font-weight: 400\">. For a CDSCO <a href=\"https:\/\/www.legalraasta.com\/medical-device-registration\/\">medical device license<\/a>, the general documents required are the Device Master File (DMF), Plant Master File (PMF), ISO 13485, Free Sale Certificate, Declaration of Conformity, Quality Management System (QMS) documents, label\/IFU, etc.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"4\">\n<li><b> What are CDSCO fees and the total expected cost?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><b>Ans<\/b><span style=\"font-weight: 400\">. The cost for medical devices is classified by their manufacturing site and the fee per product. The fee structure is classified as:<\/span><\/p>\n<p style=\"text-align: justify\"><b>A Class Medical Devices<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Fee Per Manufacturing Site:<\/b><span style=\"font-weight: 400\"> Rs 83,000\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Fee Per Product:<\/b><span style=\"font-weight: 400\"> Rs 4,165<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>B Class Medical Devices<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Fee Per Manufacturing Site:<\/b><span style=\"font-weight: 400\"> Rs 166,600<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Fee Per Product:<\/b><span style=\"font-weight: 400\"> Rs 83,000<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><b>C Class &amp; D Medical Devices<\/b><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><b>Fee Per Manufacturing Site:<\/b><span style=\"font-weight: 400\"> Rs 229,000<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Fee Per Product<\/b><span style=\"font-weight: 400\">: Rs 124,950<\/span><\/li>\n<\/ul>\n<ol style=\"text-align: justify\" start=\"5\">\n<li><b> What is the typical CDSCO approval timeline?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Ans. The general timeline for medical device registration is between 6 and 9 months.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"6\">\n<li><b> How can I check my device class (A\/B\/C\/D)?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Ans. To classify the devices into Class A, B, C, and D, utilize the official Central Drugs Standard Organization (CDSCO) digital platform. Device classifications depend on their use and the potential risk factors.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"7\">\n<li><b> Which medical devices require CDSCO licensing in India?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Ans. The registration with CDSCO is mandatory for those medical devices that are classified under categories A, B, C, and D.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"8\">\n<li><b> What is the correct application form (MD-3\/MD-5\/MD-7\/MD-9, etc.)?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Ans. The accurate application forms vary according to medical device class (A, B, C, and D) and the type of license.\u00a0<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"9\">\n<li><b> Do I need ISO 13485 for CDSCO medical device licensing?\u00a0<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Ans. While an ISO 13485 certification is optional, it is strongly advisable for companies wishing to manufacture high-risk devices (Class C\/D).<\/span><\/p>\n<ol style=\"text-align: justify\" start=\"10\">\n<li><b> Why do CDSCO applications get rejected or delayed?<\/b><\/li>\n<\/ol>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Ans. Incomplete or inaccurate documentation, lack of compliance with CDSCO regulations, and other administrative errors result in the refusal of applications to import medical devices into India.<\/span><\/p>\n<h4 style=\"text-align: justify\"><span class=\"ez-toc-section\" id=\"19_Final_Thoughts_CDSCO_Medical_Device_Registration_for_Manufacturing_or_Importing\"><\/span><b>19. Final Thoughts | CDSCO Medical Device Registration for Manufacturing or Importing<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In conclusion, for approval of the CDSCO <\/span><strong>Medical Device License<\/strong><span style=\"font-weight: 400\"><strong> in India<\/strong>, manufacturers or importers need to classify their medical device into Class A, B, C, or D. Must create the necessary documentation, including the Plant\/Device Master File (PMF\/DMF) and the Quality Management System (QMS), which is required to comply with ISO 13485, and create an account online at the SUGAM portal. Further, complete the necessary forms for your application; specifically, MD-3\/MD-7 for manufacturing and MD-14\/MD-16 for importation. Paying the prescribed fee for importation or for local premises is mandatory. <\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The time required for review will vary by class (A\/B 1-3 months, C\/D 6-9+ months). A QMS compliant with ISO 13485 is required to fulfill the Quality Management System section of the application, and the applicant must be familiar with the Medical Device Rules, 2017. In addition, the foreign device manufacturers must have an Indian Authorized Agent (IAA) to apply for a medical device license in India.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, CDSCO, which stands for Central Drugs Standard Control Organization, is one of the most recognized national regulatory authorities. This authority focuses on drugs, cosmetics, and medical device management. It is further responsible for issuing the license to the respective service. In India, CDSCO medical device registration is a legal authorization to regulate the manufacturing, [&hellip;]<\/p>\n","protected":false},"author":15,"featured_media":33986,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5155,5250],"tags":[],"class_list":["post-33985","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco","category-medical-device"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CDSCO Medical Device License in India \u2013 Process &amp; Documents<\/title>\n<meta name=\"description\" content=\"Learn CDSCO Medical Device License in India: process, required documents, fees and timeline. 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