{"id":51540,"date":"2022-12-30T11:45:49","date_gmt":"2022-12-30T06:15:49","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51540"},"modified":"2023-04-11T12:27:52","modified_gmt":"2023-04-11T06:57:52","slug":"what-are-the-challenges-and-opportunities-with-ivd-industry","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-are-the-challenges-and-opportunities-with-ivd-industry\/","title":{"rendered":"What Are The Challenges And Opportunities With IVD Industry?"},"content":{"rendered":"\n<p>While giving an interview, the Union health minister, Mansukh Mandaviya,\nsaid, \u201cIndian medical devices industry has the potential to grow at 28 per cent\neach year to reach $50 billion by 2030. He also mentioned that the central\ngovernment is planning to boost further India\u2019s strengths of skilled manpower,\nand ease of business through its industry-friendly rules which offer a huge\nmarket.\u201d The medical device sector is very huge, which is followed by a bread\nclassification such as electronic equipment, implants, consumables and\ndisposables, surgical instruments and In-Vitro diagnostic reagents. In the\nrecent years, we have seen a massive evolution in the IVD industry to support\ndifferent applications such as the screening, diagnosis and monitoring of\nchronic and infectious diseases. There is a large panel of diagnostic\ntechnologies that are currently available on the IVD industry. To put it\nsimply, In-vitro means \u2018in glass\u2019, which implies these tests are conducted in\ntest tubes. Therefore these tests are performed on the patient to detect their\ndisease, condition and infection. These tests also include next-generation\nsequencing tests, which scan a person\u2019s DNA to detect genomic variations.<\/p>\n\n\n\n<p>A large panel of diagnostic technologies is currently available in the\nIVD market. It ranges from simple lateral flow assays (LFA) intended for\nself-testing to complex solutions integrating active devices used by central\nlaboratories. IVD products also include reagents, accessories intended for use\nwith IVD devices as well as software.<\/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\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#Classification_of_Medical_Devices_Pertaining_To_In-Vitro_Diagnostic\" >Classification of Medical Devices Pertaining To In-Vitro Diagnostic<\/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\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#What_Are_The_Driving_Factors_Of_The_IVD_Industry\" >What Are The Driving Factors Of The IVD Industry?<\/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\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#What_Are_The_Challenges_Being_Faced_By_The_IVD_Industry\" >What Are The Challenges Being Faced By The IVD Industry?<\/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\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#Governing_Authorities_in_India\" >Governing Authorities in India<\/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\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#Medical_Device_Registration\" >Medical Device Registration<\/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\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#Eligibility_Criteria_to_Be_an_Authorised_Indian_Agent_AIR\" >Eligibility Criteria to Be an Authorised Indian Agent\n(AIR)?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#Documents_Required_For_the_Registration\" >Documents Required For the Registration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/what-are-the-challenges-and-opportunities-with-ivd-industry\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices_Pertaining_To_In-Vitro_Diagnostic\"><\/span>Classification of Medical Devices Pertaining To In-Vitro Diagnostic<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The safety, quality, and\nperformance of these IVD medical devices are regulated under <strong>the\nDrugs and Cosmetics Act of 1940<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/www.indiacode.nic.in\/bitstream\/123456789\/2409\/1\/a1940-23.pdf\"><strong>[1]<\/strong><\/a><\/sup> and Drugs and the Cosmetics Rules of 1945. IVD medical devices are\nclassified into number of classes as per intended use and risk associated with\nthem, and these\nfour classes are: A (Low risk), B (Low moderate risk), C (Moderate high risk),\nand D (High risk). This classification is based on the intended use. The risk\nassociated with IVD medical devices and other parameters is enlisted in the\nFirst Schedule of MDR of 2017.<\/p>\n\n\n\n<p>Mentioned below is the list of medical devices\npertaining to In-vitro diagnostic with their risk category;<\/p>\n\n\n\n<table class=\"wp-block-table table table-bordered\"><tbody><tr><td>\n  <strong>S. No<\/strong>\n  <\/td><td>\n  <strong>IVD Devices<\/strong><strong><\/strong>\n  <\/td><td>\n  <strong>Risk Class<\/strong><strong><\/strong>\n  <\/td><\/tr><tr><td>\n  1\n  <\/td><td>\n  Alcohol body fluid analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  2\n  <\/td><td>\n  Amino acid analyser\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  3\n  <\/td><td>\n  Bilirubinometry analyser\n  <\/td><td>\n  A &amp; C\n  <\/td><\/tr><tr><td>\n  4\n  <\/td><td>\n  Catecholamine analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  5\n  <\/td><td>\n  Chemiluminescent immunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  6\n  <\/td><td>\n  Chloride coulometric titration analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  7\n  <\/td><td>\n  Cholesterol analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  8\n  <\/td><td>\n  Clinical Chemistry analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  9\n  <\/td><td>\n  Creatinine analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  10\n  <\/td><td>\n  Enzyme analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  11\n  <\/td><td>\n  Glycated hemoglobin analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  12\n  <\/td><td>\n  High-performance liquid chromatography analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  13\n  <\/td><td>\n  Identification and antibiotic susceptibility\n  analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  14\n  <\/td><td>\n  Ion-selective analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  15\n  <\/td><td>\n  Lactate analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  16\n  <\/td><td>\n  Lipid profile analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  17\n  <\/td><td>\n  Nitrogen body fluid sample analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  18\n  <\/td><td>\n  Protein analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  19\n  <\/td><td>\n  Radioimmunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  20\n  <\/td><td>\n  ABO\/Rh (D) blood grouping analyser\n  <\/td><td>\n  A &amp; D\n  <\/td><\/tr><tr><td>\n  21\n  <\/td><td>\n  Blood cell count analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  22\n  <\/td><td>\n  Blood coagulation analyser\n  <\/td><td>\n  A &amp; C\n  <\/td><\/tr><tr><td>\n  23\n  <\/td><td>\n  Blood group\/ antibody screening analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  24\n  <\/td><td>\n  Co-oximetry analyser\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  25\n  <\/td><td>\n  Erythrocyte sedimentation analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  26\n  <\/td><td>\n  Flow cytometry analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  27\n  <\/td><td>\n  Heparin analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  28\n  <\/td><td>\n  Osmotic fragility analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  29\n  <\/td><td>\n  Reticulocyte analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  30\n  <\/td><td>\n  Blood gas analyser\n  <\/td><td>\n  A &amp; C\n  <\/td><\/tr><tr><td>\n  31\n  <\/td><td>\n  Hemoglobin analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  32\n  <\/td><td>\n  Platelet aggregation analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  33\n  <\/td><td>\n  Densitometry analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  34\n  <\/td><td>\n  Enzyme immunoassay (EIA) analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  35\n  <\/td><td>\n  Fluorescent immunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  36\n  <\/td><td>\n  Immunology analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  37\n  <\/td><td>\n  Immunofluorescent analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  38\n  <\/td><td>\n  Microarray analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  39\n  <\/td><td>\n  Particle counting immunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  40\n  <\/td><td>\n  Photometric immunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  41\n  <\/td><td>\n  Antimicrobial susceptibility analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  42\n  <\/td><td>\n  Blood culture analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  43\n  <\/td><td>\n  Gene analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  44\n  <\/td><td>\n  Immunoturbidometry analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  45\n  <\/td><td>\n  Micro-organism identification analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  46\n  <\/td><td>\n  Nucleic acid amplification (PCR) analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  47\n  <\/td><td>\n  Yeast\/fungi identification analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  48\n  <\/td><td>\n  Gas chromatography analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  49\n  <\/td><td>\n  Mass spectrometry analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  50\n  <\/td><td>\n  Nephelometry immunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  51\n  <\/td><td>\n  Fecal occult blood immunoassay analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  52\n  <\/td><td>\n  Spermatozoa \/semen analyser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  53\n  <\/td><td>\n  Blood smear cassettes\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  54\n  <\/td><td>\n  Blood smear instrument\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  55\n  <\/td><td>\n  Blood tube mixer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  56\n  <\/td><td>\n  Blood component separator\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  57\n  <\/td><td>\n  Blood collection tube\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  58\n  <\/td><td>\n  Cell washer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  59\n  <\/td><td>\n  Colony counter\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  60\n  <\/td><td>\n  Inoculating loop\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  61\n  <\/td><td>\n  Magnetic particle separation instrument\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  62\n  <\/td><td>\n  Microbial incubator\/imaging instrument\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  63\n  <\/td><td>\n  Microplate seal roller\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  64\n  <\/td><td>\n  Microplate washer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  65\n  <\/td><td>\n  Microscope slide coverslipper\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  66\n  <\/td><td>\n  Microscope slide hybridization\/denaturation\n  incubator\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  67\n  <\/td><td>\n  Microscope slide maker\/ stainer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  68\n  <\/td><td>\n  Microscope slide washer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  69\n  <\/td><td>\n  Nucleic acid sample preparation instrument\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  70\n  <\/td><td>\n  Side-mounted tissue dissection system\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  71\n  <\/td><td>\n  Specimen processing instrument\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  72\n  <\/td><td>\n  Cancer cell marker\/ morphology image analysis\n  software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  73\n  <\/td><td>\n  Cancer risk assessment interpretative software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  74\n  <\/td><td>\n  Cardiovascular risk\/probability assessment\n  interpretative software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  75\n  <\/td><td>\n  Congenital defect\/syndrome risk&nbsp; assessment\n  interpretative software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  76\n  <\/td><td>\n  Human genomic analysis &nbsp; interpretative software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  77\n  <\/td><td>\n  Laboratory instrument\/analyser application software\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  78\n  <\/td><td>\n  Microbial identification interpretative software\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  79\n  <\/td><td>\n  Osteoporosis risk assessment interpretative\n  software\n  <\/td><td>\n  A\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Are_The_Driving_Factors_Of_The_IVD_Industry\"><\/span>What Are The Driving Factors Of The IVD Industry?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Recent technological\ndevelopment and automation are changing the way we understand a disease and\ntreat it. We have entered an era where we can detect or predict the disease\nwith more accurately. Now it\u2019s very easy for our doctors to detect any disease\nat its early stage, not even this it is very easy now to check how an\nindividual\u2019s body will respond to a drug.<\/p>\n\n\n\n<p>Following are some of the key\ndriving factors of the IVD industry:<\/p>\n\n\n\n<ul><li>Personalized care<\/li><li>It helps in rapid disease identification<\/li><li>It Improves quality of life and healthcare\nadvancements&nbsp;<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Are_The_Challenges_Being_Faced_By_The_IVD_Industry\"><\/span>What Are The Challenges Being Faced By The IVD Industry?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nadvancement of technologies and the ever-changing healthcare ecosystem might\nseem overwhelming to some. It is very tough to keep up with all the regulations\nand sustain yourself in the market. Given the scope and the velocity of these\nchanges, it is very tough for the makers to keep up with competition from the\nemerging market and the difference in the customer behaviour. <\/p>\n\n\n\n<p>Here are\nsome of the key challenges faced by the IVD industries: <\/p>\n\n\n\n<ul><li>Adoption\nrisk<\/li><li>Reimbursement\nrisk <\/li><li>Limited\nmarket intelligence <\/li><li>Limited\ngrowth in the market<\/li><li>Product development takes time, while technology and consumer expectations increase at\na much faster rate<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Governing_Authorities_in_India\"><\/span>Governing Authorities in India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The medical device regulatory procedure was entirely\naltered by the Medical Device Rules of 2017. CDSCO, which stands for The\nCentral Drugs Standard Control Organisation, is the National Regulatory\nAuthority of India. It is managed by the Directorate General of Health Services\nunder Ministry of Health &amp; Family Welfare. CDSCO is responsible for\nimplementing all the policies and acts of state drug licensing authorities. <\/p>\n\n\n\n<p>For the manufacture of class A\/B devices, a license or\nloan license against the application is granted by the State Licensing\nAuthority. While for manufacturing class C\/D devices, the license or loan\nlicense is granted by CLA. These licenses remain valid in perpetuity, unless\nsuspended or cancelled if the license retention fee is paid before the\ncompletion of 5 years from the date of issue.<\/p>\n\n\n\n<p>So all the manufacturers of class A and class B medical\ndevices, the license against the application is granted by the state licensing\nauthority; on the other hand, for the manufacturer of class C and class D\nmedical devices, the license against the application is granted by CLA.\nTherefore for all the manufacturers or the importers of the IVD medical\ndevices, it is crucial to register their products before start marketing them\nin India. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Registration\"><\/span>Medical Device Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Applications for <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/in-vitro-diagnostic-device-manufacturing-license\">IVD medical devices<\/a><\/strong> must be filed through the online SUGAM portal, which\nCDSCO also uses to manage applications. Mentioned below is a step-by-step\nprocess for CDSCO registration. All the importers, as well as the makers, must adhere\nto the following procedure before entering into the IVD industry.<\/p>\n\n\n\n<ul><li>First step is to\ndetermine whether your product requires registration or not.<\/li><li>After this the\napplicant has to appoint an authorized Indian agent for CDSCO registration for\nIVD medical devices. <\/li><li>Submit the\napplication under Form 40 with all the required documents.<\/li><li>Obtain a\nregistration certificate in Form 41<\/li><li>After the documents\nare submitted, CDSCO will get back to the Indian agent with a query letter (if\nany). If the responses given by the agent are satisfactory to CDSCO, the\nlicence will be granted. <\/li><li>The registration\ncertificate is valid for a term of three years. <\/li><li>Obtain import\nlicence number.<\/li><li>A Form-10 has to be\napplied at CDSCO. The application has to be made under Form 8 along with Form 9\n(Which mentions the registration certificate number. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eligibility_Criteria_to_Be_an_Authorised_Indian_Agent_AIR\"><\/span>Eligibility Criteria to Be an Authorised Indian Agent\n(AIR)?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To enter into the\nIVD industry all the manufacturers or the importer must appoint AIR in order to\nproceed with the process of registration.&nbsp;<\/p>\n\n\n\n<ol><li>Must be a resident of India<\/li><li>Must have relevant\n     experience in the healthcare industry<\/li><li>Must hold power of attorney\n     to submit medical device registration documents to CDSCO<\/li><li>Must hold wholesale drug\n     licenses in forms 20B and 21B.&nbsp;<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_For_the_Registration\"><\/span>Documents Required For the Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the exhaustive list of documents required for the CDSCO registration for IVD\nmedical devices: <\/p>\n\n\n\n<ul><li>Application form\nfor registration<\/li><li>Challan TR6<\/li><li>ISO 13485<\/li><li>A copy of the Power\nof Attorney<\/li><li>An Undertaking by\nthe applicant stating that all the information provides is true and accurate <\/li><li>Certificate of\nquality assurance<\/li><li>C.E. Design\naccreditation<\/li><li>Declaration of\nconformity<\/li><li>Schedule D(I)<\/li><li>Master Plant File<\/li><li>Device master file<\/li><li>Free sale\ncertificate<\/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>Medical devices, particularly the IVD industry, have proven their importance in the fight against the corona pandemic in the last two years. We have seen how the IVD industry was at the forefront of this fight against the pandemic. It was the main hero in fighting this battle. <\/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\/parameters-for-classification-of-ivd-medical-devices\/\">Parameters For Classification Of IVD Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>While giving an interview, the Union health minister, Mansukh Mandaviya, said, \u201cIndian medical devices industry has the potential to grow at 28 per cent each year to reach $50 billion by 2030. He also mentioned that the central government is planning to boost further India\u2019s strengths of skilled manpower, and ease of business through its [&hellip;]<\/p>\n","protected":false},"author":48,"featured_media":51541,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2990],"acf":{"service_id":"385"},"authorName":"Astitva Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/12\/MicrosoftTeams-image-27.jpg","authorDescription":"Astitva Kumar is an advocate by profession and has completed her BBA. LLB from IP University. She is an avid reader, researcher, and legal writer. Her areas of interest include mediation, conflict resolution, finance, cyber laws, and taxation.","postViews":2716,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51540"}],"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\/48"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51540"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51540\/revisions"}],"predecessor-version":[{"id":54883,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51540\/revisions\/54883"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51541"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51540"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51540"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51540"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}