{"id":47136,"date":"2022-08-23T11:19:21","date_gmt":"2022-08-23T05:49:21","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=47136"},"modified":"2022-08-23T11:19:22","modified_gmt":"2022-08-23T05:49:22","slug":"when-is-import-of-medical-devices-for-personal-use-allowed","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/","title":{"rendered":"When is Import of Medical Devices for Personal Use Allowed?"},"content":{"rendered":"\n<p>Chapter V of the <strong>Medical Device Rules 2017<\/strong><sup><a href=\"https:\/\/www.dfda.goa.gov.in\/circulars-orders-notifications\/notification\/419-medical-device-rules-2017\"><strong>[1]<\/strong><\/a><\/sup> covers rules and regulations for importing Medical Devices into India. It discusses the conditions and rules for grant of Import licenses for multiple purposes. It allows Import of <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical Device<\/strong><\/a> for Personal Usein small quantity, which are otherwise prohibited for import as per section 10 of The Drugs and Cosmetics act, 1940. Form MD-20 is submitted as the application for obtaining permission for the same, and Form MD-21 is obtained from the Central Licensing Authority as permission for the grant of license for import of medical devices for personal use.<\/p>\n\n\n\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 ez-toc-toggle\" style=\"cursor:pointer\">Page 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 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/#Application_for_permission_to_import_a_small_quantity_of_medical_devices_for_personal_use\" >Application for permission to\nimport a small quantity of medical devices for personal use<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/#Application_Form_required_for_the_Import_of_Medical_Device_for_Personal_Use\" >Application Form required for the\nImport of Medical Device for Personal Use<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/#Required_documents_for_Import_of_Medical_Device_for_Personal_Use\" >Required documents for Import\nof Medical Device for Personal Use<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/#Conditions_applicable_for_Medical_Device_Imported_for_personal_use\" >Conditions applicable for\nMedical Device Imported for personal use<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/#Prohibition_of_Import_on_Medical_Devices_and_Drugs\" >Prohibition of Import on\nMedical Devices and Drugs<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/when-is-import-of-medical-devices-for-personal-use-allowed\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_for_permission_to_import_a_small_quantity_of_medical_devices_for_personal_use\"><\/span>Application for permission to\nimport a small quantity of medical devices for personal use<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 43 of\nthe Medical Device Rules 2017 lays down conditions for the import medical\ndevices for personal use. Medical devices which are prohibited under section 10\nor Drugs and Cosmetics Act 1940 may be allowed for import in small quantities\nfor personal use under the following conditions-<\/p>\n\n\n\n<ul><li>The medical device should be exclusively for the\npassenger&#8217;s personal use and must be carried as a part of the personal baggage\nof the passenger. <\/li><li>According to the customs authorities&#8217;\ndirections, the medical device shall be declared as the personal baggage of the\npassenger.<\/li><li>The quantity of medical device which has to be\nimported shall not exceed the quantity specified by the registered medical\npractitioner. <\/li><li>A registered medical practitioner should\nprescribe the medical device. <\/li><li>The imported medical device should include an\ninvoice or a statement that specifies the product&#8217;s name and quantity.<\/li><\/ul>\n\n\n\n<p>If there is a\nsmall quantity of Medical device which is prohibited for import under sec 10 of\nthe Drugs &amp; Cosmetics Act 1940, and it is not a part of bona fide personal\nbaggage of the importer, then there is a confirmation required stating that the\ndevice is for bona fide personal use, in an application through Form MD-20. The\nconfirmation of the bona fide personal use of a medical device shall be accompanied\nby relevant documents and a prescription made by a registered medical\npractitioner. The application is submitted to the Central Licensing Authority. <\/p>\n\n\n\n<p>If the Central\nLicensing Authority is satisfied with the application form MD-20 and all the attached\ndocuments and information, It may grant permission to the application through\nform MD-21. In case of any rejection, the CLA must record the reasons for doing\nso, in writing, within 7 days from the date of application. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_Form_required_for_the_Import_of_Medical_Device_for_Personal_Use\"><\/span>Application Form required for the\nImport of Medical Device for Personal Use<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Application Form<\/strong>\n  <\/td><td>\n  <strong>Approval Form<\/strong>\n  <\/td><td>\n  <strong>Risk\/Class <\/strong>\n  <\/td><td>\n  <strong>Licensing\n  Authority<\/strong>\n  <\/td><\/tr><tr><td>\n  Form MD-20 is used an Application\n  for the permission for Import of Medical Device for Personal Use\n  <\/td><td>\n  Form MD-21 is given by the licensing authority as a\n  permission for Import of Medical Device for Personal Use\n  <\/td><td>\n  A,B,C,D\n  <\/td><td>\n  CDSCO\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Required_documents_for_Import_of_Medical_Device_for_Personal_Use\"><\/span>Required documents for Import\nof Medical Device for Personal Use<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are\nsome vital documents required for Import of Medical Device for Personal Use:<\/p>\n\n\n\n<ul><li>Authorisation letter from a patient<\/li><li>Patient ID proof <\/li><li>ID proof of the person collecting the shipment <\/li><li>Name and Address of the manufacturing site <\/li><li>Details of the Medical Devices which has to be\nimported <\/li><li>Name and quantity of the medical device which\nhas to be imported <\/li><li>A written prescription along with complete\ninformation from the recommending doctor <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_applicable_for_Medical_Device_Imported_for_personal_use\"><\/span>Conditions applicable for\nMedical Device Imported for personal use<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per section\n43(4) of the Medical Device Rules 2017, the medical device for Import of\nMedical Device for Personal Use is subject to the following conditions-<\/p>\n\n\n\n<ul><li>If the Customs Authorities direct, the medical\ndevices shall be declared to them.<\/li><li>The shipment of a medical device shall include\ndetails of the name and quantity of the medical device in a statement or\nInvoice.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prohibition_of_Import_on_Medical_Devices_and_Drugs\"><\/span>Prohibition of Import on\nMedical Devices and Drugs <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 10 of\nthe Drugs and Cosmetics Act 1940 states the list of products prohibited for\nimport. <\/p>\n\n\n\n<ul><li>Any Drug or Cosmetic that is not of standard\nquality.<\/li><li>Any misbranded \/ adulterated drug or spurious\ncosmetic.<\/li><li>Any Drug or cosmetic that requires a license for\nimport, and if imported, it should comply with the license of the same.<\/li><li>Any patent or proprietary medicine is prohibited\nunless there is a detailed description of the quantity and list of true\nformulas and active ingredients used. <\/li><li>Any drug that claims to cure or mitigate any\ndisease or ailment or to give any effect to the patient through any statement,\ndesign or related device. <\/li><li>Any cosmetic containing any ingredient that is\nunsafe or harmful for use as per the directions provided. <\/li><li>Any drug or cosmetic which is prohibited for\nimport in accordance with the rule of the act. <\/li><\/ul>\n\n\n\n<p>Some exemptions\nexist for the prohibition of import of drugs and cosmetics according to the\nact. These are-<\/p>\n\n\n\n<ul><li>A small quantity of drugs to be imported for\nexamination, test or analysis for personal use shall be exempted from the\nprohibition.<\/li><li>If the drug or cosmetic is not of standard\nquality, the central government may consult the board and may permit the import\nthrough a notification in the official gazette. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>India has recently become more dependable on the Import of Medical devices. The increase in import of medical devices has been noted for about Rs 63,200 crore in the year 2021-22, which has increased by 41% from Rs 44,708 crore in the FY 2021, as per the Association of Indian Medical Device Industry. The Indian Medical Device Market is estimated to be Rs 87,752 crore, with foreign suppliers contributing about 70% of the Market. Due to the larger market size for the Import of Medical Devices, many rules govern a single procedure. If not guided by a relevant source, the Import licensing process may become over-complicated, and a single missed document may cause multiple losses at once or even cancellation of the license. Thus, it is always recommended to take the aid of a legal expert or a guide to go through the entire process at ease, thus saving time and money. <\/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-of-software-as-medical-device-in-india\/\">Registration of Software as Medical Device in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chapter V of the Medical Device Rules 2017[1] covers rules and regulations for importing Medical Devices into India. It discusses the conditions and rules for grant of Import licenses for multiple purposes. It allows Import of Medical Device for Personal Usein small quantity, which are otherwise prohibited for import as per section 10 of The [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":47138,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2625],"acf":{"service_id":"385"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":6100,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47136"}],"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\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=47136"}],"version-history":[{"count":9,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47136\/revisions"}],"predecessor-version":[{"id":47147,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/47136\/revisions\/47147"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/47138"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=47136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=47136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=47136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}