Admin 
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 devices industry can expand from $12 billion to $50 billion by 2030, reducing import reliance to 35% and boosting exports to $18 billion.
This GTRI report has identified six action points for the Government and industry for accelerating growth
1. Customs Duty Adjustment: Raise Basic Customs Duty from 0-7.5% to 15-20% for non-ITA1 devices, encouraging quality production and exports.
2. ITC Restriction: Remove Input Tax Credit for IGST on items with zero import duty to prevent unfair advantages over domestic producers.
3. Ban Used/Refurbished Imports: Halt import of used/old medical devices, ensuring safety, environmental protection, and domestic industry growth.
4. PLI Plus Scheme: Introduce Performance Linked Incentive scheme to promote value-added production for high-import products.
5. Combat Foreign Influence: Identify and counter foreign lobby influence on industry and research reports shaping policy.
6. Promote Local Sourcing: Encourage local procurement, ensuring domestic manufacturers compete effectively during critical situations.
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.
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:
- Re-examination and implementation of Schedule MIII (a draft guidance on good manufacturing practices and facility requirements)
- System for export labelling
- Clinical evaluation and adverse reporting clarification
- State licensing authority to extend free sales certificate validity from 2 years to 5 years to allow exports.
- Create a list of manufacturers with export licensing for easy access to regulatory authorities worldwide.
Top 3 Product Categories of Medical devices Exports from India are
- HSN Code 90189099: other
- HSN Code 90183930: other: cannulae
- HSN Code 90183990: other
India-Top 50 Medical Device global exports FY2023
| S No. | HS Code | Product category |
| 1 | 90183990 | I.V. Administration Sets, Scalp Vien Sets, Infusion Sets, Blood Collection Tubes |
| 2 | 39232100 | Medical Waste Disposable Bags -Plastic |
| 3 | 39239090 | Other Plastic Articles forPackagingof Goods etc. |
| 4 | 90223000 | X-ray tubes |
| 5 | 90015000 | Spectacle Lenses of Other Materials |
| 6 | 90183930 | Cannulae |
| 7 | 90181300 | Magnetic resonance imaging apparatus |
| 8 | 90189099 | Other Surgical Instruments and Appliances (Including Stapler / Skin Stapler, Tourniquet Electronic, Trocar) |
| 9 | 90181990 | Other- Electro – Diagnostic Apparatus |
| 10 | 90213900 | Others (Including Intraocular Lenses (Rigid/ Foldable), Ophthalmic Implants etc. |
| 11 | 40151200 | Gloves, Mittens and Mitts for medical, surgical, dental or veterinary purposes – |
| 12 | 90229090 | X-Ray Film Viewer, Treatment Planning and Robotic Navigation Solutions for Image Guided Procedures |
| 13 | 38229090 | Other (Including Diagnostic Reagent) |
| 14 | 38089400 | Disinfectants (Including hand sanitizer) |
| 15 | 90221490 | Other X- ray Machines for Medical uses (Including EEG Apparatus, ECG Machine) |
| 16 | 90211000 | Orthopedic or fracture appliances |
| 17 | 90189019 | Other Diagnostics Instruments (Including Pulse Oximeter) |
| 18 | 40141010 | Rubber Contraceptives Male (Condoms) / Sheath contraceptives |
| 19 | 38221100 | Malaria Diagnostic Test Kits |
| 20 | 90183100 | Syringes, W/N With Needles |
| 21 | 90278990 | Other (Including Tautomatic Hematology Analyzer, Analyzer-Fully Automated Clinical Chemistry) |
| 22 | 90279090 | Others Parts and Accessories of HDG 9027 |
| 23 | 90213100 | Artificial Joints |
| 24 | 90189044 | Endoscope |
| 25 | 90189031 | Artificial Dialysis Apparatus and Haemodialyser (Portable / Non- Portable) |
| 26 | 90181100 | Electro-cardiographs |
| 27 | 90183910 | Catheters (for Urine, Stool) |
| 28 | 90219090 | Others (Including Hernia Mesh, Surgical Mesh, Coronary Stent, Polypropylene Mesh for Hernia Repair) |
| 29 | 90189032 | Blood transfusion apparatus |
| 30 | 90189022 | Surgical Knives, Scissors and Blade |
| 31 | 90271000 | Gas analysis apparatus |
| 32 | 30059090 | Other Dressing Articles N.E.S |
| 33 | 90189029 | Other Surgical Tools (Including Medical surgical instruments for operation theatre. fcps, tubular) |
| 34 | 30061010 | Sterile Surgical Catgut, Similar Material And Sterile Tissue Adhrsives For Surgical Wound Closure |
| 35 | 65050090 | Hats And Other Headgears Etc. Excl. Hair-nets (Including Head Cover) |
| 36 | 90185090 | Other- Ophthalmic Surgical Instrument and Appliances (Including Auto Keratometer/ Ref Keratometer) |
| 37 | 38221990 | Other For Medical Diagnosis (Including Diagnostic Reagent Kits/ Lab Chemicals/ Reagent For Hematology Analyzer.) |
| 38 | 30059040 | Bandages Without Adhesive Layer |
| 39 | 90049090 | Others (Goggles) |
| 40 | 90183210 | Suture Needles |
| 41 | 90181290 | Other Electro – Diagnostic Apparatus |
| 42 | 90013000 | Contact Lenses of Any Material, Unmounted |
| 43 | 90275090 | Other (Including Line Immuno assay Processor) |
| 44 | 90181210 | Linear ultrasound scanner |
| 45 | 90183920 | Cardiac Catheters |
| 46 | 30063000 | Opacifying Preparations for X-Ray Exams; Diagnostic Reagents Designed To Be Administrated To The Patient Be Administered To The Pat |
| 47 | 96190010 | Sanitary Towels (Pads) Or Sanitary Napkins |
| 48 | 30064000 | Dental Cements and Other Dental Fillings Bone Reconstruction Cements |
| 49 | 90192090 | Other (Including Oxygen Concentrator, Saans Neonatal CPAP Device, Nebulizer, Infant Nasal Prongs, Ventilators) |
| 50 | 96190030 | Napkins And Napkin Liners For Babies |
Also Read This: A Detailed Report On Refined Petroleum Import-Export
Countries Importing From India
- UNITED STATES
- THAILAND
- CHINA
- NETHERLANDS
- AUSTRALIA
- MALDIVES
- JAPAN
- UNITED KINGDOM
- BELGIUM
- SOUTH KOREA
- OTHERS
Companies Importing from India are
- PHILIPS THAILANDLTD
- GE MEDICAL SYSTEMS INFORMATION TE
- PHILIPS MEDICAL SYSTEMS NEDERLAND BV
- PHILIPS HEALTHCARE AUSTRALIA
- GE PRECISION HEALTHCARE LLC
- INDIRA GANDHI MEMEORIAL HOSPITAL
- GE MEDICAL SYSTEMS CHINA CO LIMITED
- R H LOGISTICS LTD
- GE HEALTHCARE JAPAN CORPORATION
The following documents are typically required for exporting medical devices to India
- Free Sale Certificate: Issued by the regulatory authority to confirm the device’s free sale status in India.
- Manufacturing License: A copy of the manufacturing license obtained from the relevant Indian authority.
- Registration Certificate: If applicable, a copy of the registration certificate obtained from the CDSCO.
- Technical Specifications: Detailed technical information about the device’s design, components, and manufacturing process.
- Product Information: Brochures, labeling, and usage instructions for the device.
- Quality Certifications: Any quality certifications, such as ISO 13485, obtained for the medical device.
- Clinical Data: Relevant clinical trial data or evidence supporting the device’s safety and effectiveness.
- Regulatory Approvals: Copies of any international regulatory approvals obtained.
- Importer/Exporter License: A copy of the importer/exporter license issued by the appropriate authority.
