{"id":1498,"date":"2024-08-12T13:36:23","date_gmt":"2024-08-12T08:06:23","guid":{"rendered":"https:\/\/limeinstitute.org\/blog\/?p=1498"},"modified":"2024-08-13T11:10:57","modified_gmt":"2024-08-13T05:40:57","slug":"a-detailed-report-on-medical-devices-import-export","status":"publish","type":"post","link":"https:\/\/limeinstitute.org\/blog\/a-detailed-report-on-medical-devices-import-export\/","title":{"rendered":"A Detailed Report On Medical Devices Import-Export"},"content":{"rendered":"\n<p>In the fiscal year 2022-23, India exported medical consumables and disposables worth US$ 1.6 billion, surpassing imports valued at around US$ 1.1 billion. Exports witnessed a 16% increase, while imports experienced a 33% decline. The Indian Medical Devices market is estimated at $11 billion and is an attractive export sector for U.S.<\/p>\n\n\n\n<p>The Indian medical devices industry can expand from $12 billion to $50 billion by 2030, reducing import reliance to 35% and boosting exports to $18 billion.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>This GTRI report has identified six action points for the Government and industry for accelerating growth<\/strong><\/h2>\n\n\n\n<p><strong>1. Customs Duty Adjustment<\/strong>: Raise Basic Customs Duty from 0-7.5% to 15-20% for non-ITA1 devices, encouraging quality production and exports.<\/p>\n\n\n\n<p><strong>2.<\/strong> <strong>ITC Restriction<\/strong>: Remove Input Tax Credit for IGST on items with zero import duty to prevent unfair advantages over domestic producers.<\/p>\n\n\n\n<p><strong>3. Ban Used\/Refurbished Imports<\/strong>: Halt import of used\/old medical devices, ensuring safety, environmental protection, and domestic industry growth.<\/p>\n\n\n\n<p>4<strong>. PLI Plus Scheme:<\/strong> Introduce Performance Linked Incentive scheme to promote value-added production for high-import products.<\/p>\n\n\n\n<p><strong>5. Combat Foreign Influence<\/strong>: Identify and counter foreign lobby influence on industry and research reports shaping policy.<\/p>\n\n\n\n<p><strong>6. Promote Local Sourcing<\/strong>: Encourage local procurement, ensuring domestic manufacturers compete effectively during critical situations.<\/p>\n\n\n\n<p>The potential of the Indian medical device industry can be realized through these strategic actions, contributing to economic growth, self-sufficiency, and improved healthcare services.<\/p>\n\n\n\n<p><strong>To increase export of medical devices in the country, the Ministry of Health and Family Welfare (MOHFW) and Central Drugs Standard Control Organization (CDSCO) implemented the following initiatives<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Re-examination and implementation of Schedule MIII (a draft guidance on good manufacturing practices and facility requirements)<\/li>\n\n\n\n<li>System for export labelling<\/li>\n\n\n\n<li>Clinical evaluation and adverse reporting clarification<\/li>\n\n\n\n<li>State licensing authority to extend free sales certificate validity from 2 years to 5 years to allow exports.<\/li>\n\n\n\n<li>Create a list of manufacturers with export licensing for easy access to regulatory authorities worldwide.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Top 3 Product Categories of Medical devices Exports from India are<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>HSN Code 90189099: other<\/li>\n\n\n\n<li>HSN Code 90183930: other: cannulae<\/li>\n\n\n\n<li>HSN Code 90183990: other<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>India-Top 50 Medical Device global exports FY2023<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>S No.<\/strong>      <\/td><td><strong>HS Code<\/strong><\/td><td><strong>Product category<\/strong><\/td><\/tr><tr><td>1<\/td><td>90183990<\/td><td>I.V. Administration Sets, Scalp Vien Sets, Infusion Sets, Blood Collection Tubes<\/td><\/tr><tr><td>2<\/td><td>39232100<\/td><td>Medical Waste Disposable Bags -Plastic<\/td><\/tr><tr><td>3<\/td><td>39239090<\/td><td>Other Plastic Articles forPackagingof Goods etc.<\/td><\/tr><tr><td>4<\/td><td>90223000<\/td><td>X-ray tubes<\/td><\/tr><tr><td>5<\/td><td>90015000<\/td><td>Spectacle Lenses of Other Materials<\/td><\/tr><tr><td>6<\/td><td>90183930<\/td><td>Cannulae<\/td><\/tr><tr><td>7<\/td><td>90181300<\/td><td>Magnetic resonance imaging apparatus<\/td><\/tr><tr><td>8<\/td><td>90189099<\/td><td>Other Surgical Instruments and Appliances (Including Stapler \/ Skin Stapler, Tourniquet Electronic, Trocar)<\/td><\/tr><tr><td>9<\/td><td>90181990<\/td><td>Other- Electro &#8211; Diagnostic Apparatus<\/td><\/tr><tr><td>10<\/td><td>90213900<\/td><td>Others (Including Intraocular Lenses (Rigid\/ Foldable), Ophthalmic Implants etc.<\/td><\/tr><tr><td>11<\/td><td>40151200<\/td><td>Gloves, Mittens and Mitts for medical, surgical, dental or veterinary purposes &#8211;<\/td><\/tr><tr><td>12<\/td><td>90229090<\/td><td>X-Ray Film Viewer, Treatment Planning and Robotic Navigation Solutions for Image Guided Procedures<\/td><\/tr><tr><td>13<\/td><td>38229090<\/td><td>Other (Including Diagnostic Reagent)<\/td><\/tr><tr><td>14<\/td><td>38089400<\/td><td>Disinfectants (Including hand sanitizer)<\/td><\/tr><tr><td>15<\/td><td>90221490<\/td><td>Other X- ray Machines for Medical uses (Including EEG Apparatus, ECG Machine)<\/td><\/tr><tr><td>16<\/td><td>90211000<\/td><td>Orthopedic or fracture appliances<\/td><\/tr><tr><td>17<\/td><td>90189019<\/td><td>Other Diagnostics Instruments (Including Pulse Oximeter)<\/td><\/tr><tr><td>18<\/td><td>40141010<\/td><td>Rubber Contraceptives Male (Condoms) \/ Sheath contraceptives<\/td><\/tr><tr><td>19<\/td><td>38221100<\/td><td>Malaria Diagnostic Test Kits<\/td><\/tr><tr><td>20<\/td><td>90183100<\/td><td>Syringes, W\/N With Needles<\/td><\/tr><tr><td>21<\/td><td>90278990<\/td><td>Other (Including Tautomatic Hematology Analyzer, Analyzer-Fully Automated Clinical Chemistry)<\/td><\/tr><tr><td>22<\/td><td>90279090<\/td><td>Others Parts and Accessories of HDG 9027<\/td><\/tr><tr><td>23<\/td><td>90213100<\/td><td>Artificial Joints<\/td><\/tr><tr><td>24<\/td><td>90189044<\/td><td>Endoscope<\/td><\/tr><tr><td>25<\/td><td>90189031<\/td><td>Artificial Dialysis Apparatus and Haemodialyser (Portable \/ Non- Portable)<\/td><\/tr><tr><td>26<\/td><td>90181100<\/td><td>Electro-cardiographs<\/td><\/tr><tr><td>27<\/td><td>90183910<\/td><td>Catheters (for Urine, Stool)<\/td><\/tr><tr><td>28<\/td><td>90219090<\/td><td>Others (Including Hernia Mesh, Surgical Mesh, Coronary Stent, Polypropylene Mesh for Hernia Repair)<\/td><\/tr><tr><td>29<\/td><td>90189032<\/td><td>Blood transfusion apparatus<\/td><\/tr><tr><td>30<\/td><td>90189022<\/td><td>Surgical Knives, Scissors and Blade<\/td><\/tr><tr><td>31<\/td><td>90271000<\/td><td>Gas analysis apparatus<\/td><\/tr><tr><td>32<\/td><td>30059090<\/td><td>Other Dressing Articles N.E.S<\/td><\/tr><tr><td>33<\/td><td>90189029<\/td><td>Other Surgical Tools (Including Medical surgical instruments for operation theatre. fcps, tubular)<\/td><\/tr><tr><td>34<\/td><td>30061010<\/td><td>Sterile Surgical Catgut, Similar Material And Sterile Tissue Adhrsives For Surgical Wound Closure<\/td><\/tr><tr><td>35<\/td><td>65050090<\/td><td>Hats And Other Headgears Etc. Excl. Hair-nets (Including Head Cover)<\/td><\/tr><tr><td>36<\/td><td>90185090<\/td><td>Other- Ophthalmic Surgical Instrument and Appliances (Including Auto Keratometer\/ Ref Keratometer)<\/td><\/tr><tr><td>37<\/td><td>38221990<\/td><td>Other For Medical Diagnosis (Including Diagnostic Reagent Kits\/ Lab Chemicals\/ Reagent For Hematology Analyzer.)<\/td><\/tr><tr><td>38<\/td><td>30059040<\/td><td>Bandages Without Adhesive Layer<\/td><\/tr><tr><td>39<\/td><td>90049090<\/td><td>Others (Goggles)<\/td><\/tr><tr><td>40<\/td><td>90183210<\/td><td>Suture Needles<\/td><\/tr><tr><td>41<\/td><td>90181290<\/td><td>Other Electro &#8211; Diagnostic Apparatus<\/td><\/tr><tr><td>42<\/td><td>90013000<\/td><td>Contact Lenses of Any Material, Unmounted<\/td><\/tr><tr><td>43<\/td><td>90275090<\/td><td>Other (Including Line Immuno assay Processor)<\/td><\/tr><tr><td>44<\/td><td>90181210<\/td><td>Linear ultrasound scanner<\/td><\/tr><tr><td>45<\/td><td>90183920<\/td><td>Cardiac Catheters<\/td><\/tr><tr><td>46<\/td><td>30063000<\/td><td>Opacifying Preparations for X-Ray Exams; Diagnostic Reagents Designed To Be Administrated To The Patient Be Administered To The Pat<\/td><\/tr><tr><td>47<\/td><td>96190010<\/td><td>Sanitary Towels (Pads) Or Sanitary Napkins<\/td><\/tr><tr><td>48<\/td><td>30064000<\/td><td>Dental Cements and Other Dental Fillings Bone Reconstruction Cements<\/td><\/tr><tr><td>49<\/td><td>90192090<\/td><td>Other (Including Oxygen Concentrator, Saans Neonatal CPAP Device, Nebulizer, Infant Nasal Prongs, Ventilators)<\/td><\/tr><tr><td>50<\/td><td>96190030<\/td><td>Napkins And Napkin Liners For Babies<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Also Read This:<\/strong> <a href=\"https:\/\/limeinstitute.org\/blog\/a-detailed-report-on-refined-petroleum-import-export\/\">A Detailed Report On Refined Petroleum Import-Export<\/a><\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img fetchpriority=\"high\" decoding=\"async\" width=\"979\" height=\"520\" src=\"https:\/\/limeinstitute.org\/blog\/wp-content\/uploads\/2024\/08\/image-6.png\" alt=\"\" class=\"wp-image-1505\" style=\"width:840px;height:auto\" srcset=\"https:\/\/limeinstitute.org\/blog\/wp-content\/uploads\/2024\/08\/image-6.png 979w, https:\/\/limeinstitute.org\/blog\/wp-content\/uploads\/2024\/08\/image-6-300x159.png 300w, https:\/\/limeinstitute.org\/blog\/wp-content\/uploads\/2024\/08\/image-6-768x408.png 768w\" sizes=\"(max-width: 979px) 100vw, 979px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Countries Importing From India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>UNITED STATES<\/li>\n\n\n\n<li>THAILAND<\/li>\n\n\n\n<li>CHINA\u00a0<\/li>\n\n\n\n<li>NETHERLANDS\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n\n\n\n<li>AUSTRALIA\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n\n\n\n<li>MALDIVES\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n\n\n\n<li>JAPAN\u00a0<\/li>\n\n\n\n<li>UNITED KINGDOM\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n\n\n\n<li>BELGIUM\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n\n\n\n<li>SOUTH KOREA<\/li>\n\n\n\n<li>OTHERS\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Companies Importing from India are<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>PHILIPS THAILANDLTD\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/li>\n\n\n\n<li>GE MEDICAL SYSTEMS INFORMATION TE<\/li>\n\n\n\n<li>PHILIPS MEDICAL SYSTEMS NEDERLAND BV<\/li>\n\n\n\n<li>PHILIPS HEALTHCARE AUSTRALIA<\/li>\n\n\n\n<li>GE PRECISION HEALTHCARE LLC<\/li>\n\n\n\n<li>INDIRA GANDHI MEMEORIAL HOSPITAL<\/li>\n\n\n\n<li>GE MEDICAL SYSTEMS CHINA CO LIMITED<\/li>\n\n\n\n<li>R H LOGISTICS LTD<\/li>\n\n\n\n<li>GE HEALTHCARE JAPAN CORPORATION<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The following documents are typically required for exporting medical devices to India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Free Sale Certificate<\/strong>: Issued by the regulatory authority to confirm the device\u2019s free sale status in India.<\/li>\n\n\n\n<li><strong>Manufacturing License<\/strong>: A copy of the manufacturing license obtained from the relevant Indian authority.<\/li>\n\n\n\n<li><strong>Registration Certificate<\/strong>: If applicable, a copy of the registration certificate obtained from the CDSCO.<\/li>\n\n\n\n<li><strong>Technical Specifications<\/strong>: Detailed technical information about the device\u2019s design, components, and manufacturing process.<\/li>\n\n\n\n<li><strong>Product Information<\/strong>: Brochures, labeling, and usage instructions for the device.<\/li>\n\n\n\n<li><strong>Quality Certifications<\/strong>: Any quality certifications, such as ISO 13485, obtained for the medical device.<\/li>\n\n\n\n<li><strong>Clinical Data<\/strong>: Relevant clinical trial data or evidence supporting the device\u2019s safety and effectiveness.<\/li>\n\n\n\n<li><strong>Regulatory Approvals:<\/strong> Copies of any international regulatory approvals obtained.<\/li>\n\n\n\n<li><strong>Importer\/Exporter License:<\/strong> A copy of the importer\/exporter license issued by the appropriate authority.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>In the fiscal year 2022-23, India exported medical consumables and disposables worth US$ 1.6 billion, surpassing imports valued at around US$ 1.1 billion. Exports witnessed a 16% increase, while imports experienced a 33% decline. The Indian Medical Devices market is estimated at $11 billion and is an attractive export sector for U.S. The Indian medical [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1506,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,9],"tags":[45,33,713,714],"class_list":["post-1498","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-news","tag-export-and-import","tag-export-import-training","tag-medical-devices","tag-medical-devices-import-export"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>A Detailed Report On Medical Devices Import-Export<\/title>\n<meta name=\"description\" content=\"The Indian Medical Devices market is estimated at $11 billion and is an attractive export sector for U.S. Imports experienced a 33% decline.\" 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