Duty Structure of Import Processes

India imports nearly 80% of its medical devices into India. India is highly dependent on imports for various medical devices, mainly for products that include cancer diagnostics, medical imaging, ultrasonic scans, and PCR technologies. India has transformed from a non-existent country to a country showing a remarkable variation in its synthesis of demand and supply to now be worth a staggering USD 2.5 Billion industry, approximately. Due to the excessive demand and supply, the government has regulated the import of Medical Devices into India. The registration and the Duty Structure for Import Processes is divided into two major pathways :

1. Importation for Notified Medical Devices
2. Importation for Non-Notified Medical Devices

For Medical Device Registration in India, 37 device categories have been listed as ‘Notified Medical Devices’ by the CDSCO. These 37 devices have a separate process for registration. The manufacturer must obtain the MD-14 from the CDSCO for these 37 devices  after which he/she can import into India. In the year 2020, there is a new amendment brought in by the CDSCO on 11th February 2020,  wherein apart from above mentioned 37 notified devices including – instruments, apparatus, appliances and implants, being used alone or in combination with other devices for  purposes like analysis, prevention, treatment, allaying of any disease, investigation, replacement or alteration or support of the anatomy among others, will be regulated under the legislation. This new Amendment is called the Medical Device (Amendment) Rules, 2020. The import process is similar to that of any other notified medical device, however the Certificate of Analysis is not required. To import into India, the manufacturer has to obtain a Registration Label After which the product can be imported into India.

This blog article talks about the Duty Structure Of Various Medical Devices In India. To learn about the import process, please click here. 

HSN Code and its significance

The Harmonized System of Nomenclature is developed by the World Customs Organization (WCO) with the aim of classifying goods all over the World in a systematic manner. HSN contains Eight-digit uniform code that classifies 5,000+ products and  is accepted worldwide. The HSN code is the basis for Duty Structure of Import Processes in India.  

Significance

1. Classification of all goods worldwide in a systematic manner facilitating International Trade.
2. Reduces the risk while doing interstate trade. 
3. It is used in the calculation of the Goods and Service Tax (GST).
4. For imports, the HSN code is mentioned in the Tax Invoices.

 HSN Code  in India 

India has been a member of the World Customs Organization(WCO) since 1971. The Duty Structure of Import Processes originally consisted of a 6-digit HSN code to classify commodities for Customs and Central Excise. Later Customs and Central Excise added two more digits to make the codes more precise, resulting in an 8 digit classification. 

Table of the HSN Codes for Medical Devices – 

The structure of HSN code has about 21 groups, and these groups are further classified into 99 chapters. The chapters are then divided into headings that are about 1244 in number. The headings are subsequently divided into 5224 subheadings. In the code itself, this plays out in the following manner:

• Each Chapter is named as a two-digit HSN number.
• Each two-digit HSN number is sub-classified into a four-digit HSN code.
• Later, such four-digit HSN codes are further sub-classified into the six-digit HSN code

The following is a table for the importation of all Medical Devices into India. It has to be strictly followed and mentioned in the GST invoices during importation. The Duty Structure of Import Processes is as follows :

Exemptions

The exemptions to the Duty Structure of Import Processes are as follows :

The Lists Mentioned in the Table Above is as Follows :

List 1

1) Amikacin 2) Amphotericin-B 3) Amrinone 4) Aprotinin 5) Baclofen 6) Bleomycin 7) Busulphan 8) BCG vaccine , Iopromide,Iotrolan 9) Chlorambucil 10) Chorionic Gonadotrophin 11) Clindamycin 12) Cyclophosphamide 13) Dactinomycin 14) Daunorubicin 15) Desferrioxamine 16) Dimercaprol 17) Disopyramide phosphate 18) Dopamine 19) Eptifibatide 20) Glucagon 21) Hydroxyurea 22) Isoprenaline 23) Isoflurane 24) Lactulose 25) Lomustine 26) Latanoprost 27) Melphalan 28) Mesna 29) Methotrexate 30) MMR (Measles, mumps and rubella) vaccine 31) Mustin Hydrochloride 32) Pancuronium Bromide 33) Praziquantel 34) Protamine 35) Quinidine 36) Sodium Cromoglycate spincaps and cartridges 37) Sodium Hyalauronate sterile 1% and 1.4% solution 38) Somatostatin 39) Strontium Chloride (85 Sr.) 40) Thioguanine 41) Tobramycin 42) Tetanus Immunoglobin 43) Typhoid Vaccines : (i) VI Antigen of Salmonella Typhi, and (ii) Ty 2la cells and attenuated non-pathogenic strains of S. Typhi 44) Tretinoin 45) Tribavirin/Ribavirin 46) Urokinase 47) Ursodeoxycholic Acid 48) V ancomycin 49) V asopressin 50) V ecuronium Bromide 51) Zidovudine 52) 5-Fluorouracil 53) Pegulated Liposomal Doxorubicin Hydrochloride injection 54) Ketoanalogue preparation of essential amino acids 55) Pergolide 56) Kit for bedside assay of Troponin-T 57) Solution for storing, transporting, flushing donor organs for transplant 58) Miltefosine 59) Milrinone Lactate 60) Methoxy Isobutile Isonitrile (MIBI) 61) Haemophilus Influenzae Type b Vaccine 62) Mycophenolate Sodium 63) Verteporfin 64) Daclizumab 65) Ganciclovir 66) Drotrecogin alfa (activated) 67) Eptacog alfa activated recombinant coagulation factor VIIa 68) Muromonab CD3 69) Japanese encephalitis vaccine 70) Valganciclovir 71) Low molecular weight heparin 72) Efavirenz 73) Emtricitabine 74) Azathioprine 75) Antinomycin D 76) Cytosine Arabinoside (Cytarabine) 77) Vinblastine Sulphate 78) Vincristine 79) Eurocollins Solution 80) Everolimus tablets/dispersible tablets 81) Poractant alfa 82) Troponin-I whole blood test kit 83) Blower/mister kit for beating heart surgery 84) Fluoro Enzyme Immunoassay Diagnostic kits 85) Tablet Telbivudine 86) Injection Exenatide 87) DTaP-IPV-Hib or PRP-T combined Vaccine 88) Pneumococcal-7 Valent Conjugate Vaccine (Diphtheria CRM197 Protein) 89) Injection Thyrotropin Alfa 90) Injection Omalizumab 91) Abatacept 92) Daptomycin 93) Entacevir 94) Fondaparinux Sodium 95) Influenza Vaccine 96) Ixabepilone 97) Lapatinib 98) Pegaptanib Sodium injection 99) Suntinib Malate 100) Tocilizumab 101) Agalsidase Beta 102) Anidulafungin 103) Caspofungin acetate 104) Desflurane USP 105) Heamostatic Matrix with Gelatin and human Thrombin 106) Imiglucerase 107) Maraviroc 108) Radiographic contrast media (Sodium and Meglumine ioxitalamate, Iobitridol and Sodium and meglumine ioxaglate) 109) Sorafenib tosylate 110) Varenciline tartrate 111) 90Yttrium 112) Nilotinib 113) Pneumococcal acchride Conjugate vaccine adsorbed 13-valent suspension for injection 114) Micafungin sodium for injection 115) Bevacizumab 116) Raltegravir potassium 117) Rotavirus Vaccine (Live Oral Pentavalent) 118) Pneumococcal Polysaccharide Vaccine 119) Temsirolimus Concentrate for infusion for injection 120) Natalizumab 121) Octreotide 122) Somatropin

List 4

1) Aurothiomalate Sodium 2) Asparaginase 3) Agglutinating Sera 4) Anti-Diphtheria Normal Human Immunoglobulin 5) Anti-human lymophocyte immunoglobulin IV 6) Anti-human thymocyte immunoglobulin IV 7) Anti-Pertussis Normal Human Immunoglobulin 8) Anti-Plague serum 9) Anti-Pseudomonas Normal Human Immunoglobulin 10) Basiliximab 11) Beractant Intra-tracheal Suspension 12) Blood group sera 13) Botulinum Toxin Type ‘A’ 14) Burn therapy dressing soaked in gel 15) Bovine Thrombin for in vitro test for diagnosis in Haemorrhagic disorders 16) Bovine Albumin 17) Bretyleum Tossylate 18) Calcium Disodium Edetate 19) Carmustine 20) Cesium Tubes 21) Calcium folinate 22) Cholestyramine 23) Christmas Factor Concentrate (Coagulation factor IX prothrombin complex concentrate) 24) Cobalt-60 25) Corticotrophin 26) Cyanamide 27) Diagnostic Agent for Detection of Hepatitis B Antigen 28) Diagnostic kits for detection of HIV antibodies 29) Diphtheria Antitoxin sera 30) Diazoxide 31) Edrophonium 32) Enzyme linked Immunosorbent Assay kits ELISA KITS 33) Epirubicin 34) Fibrinogen 35) Floxuridine 36) Flucytosin 37) Flecainide 38) Fludarabine Phosphate 39) Foetal Bovine Serum (FBS) 40) Gadolinium DTPA Dimeglumine 41) Gallium Citrate 42) Gasgangrene Anti-Toxin Serum 43) Goserlin Acetate 44) Hepatitis B Immunoglobulin 45) Hexamethylmelamine 46) Hydralazine 47) Idarubicine 48) Idoxuridine 49) Immunoassay kit for blood Fibrinogen degradation product for direct estimation for diagnostic test in D.I.C. 50) Inactivated rabies vaccine Human diploid cell 51) Inactivated rabies vaccine Vero-cell 52) Intravenous amino acids 53) Intravenous Fat Emulsion 54) Iopamidol 55) Iohexol 56) (a) Indium (III) in bleomycin (b) Indium 113 Sterile generator and elution accessories  (c)Indium 113 in brain scanning kit  (d) Indium 113 in liver scanning kit 57) Iscador, CLIA diagnostic kits 58) Levodopa with benserazine 59) Lenograstim 60) Meningococcoal A and C combined vaccine with diluant solvent 61) Methicillin 62) Metrizamide Inj with diluant 63) Monocomponent insulins 64) Mycophenolate Mofetil 65) Normal Human plasma 66) Normal Human immunoglobulin 67) Nuclear magnetic resonance contrast agent 68) Normal Human serum Albumin 69) Penicillamine 70) Pentamidine 71) Penicillinase 72) Poliomyelitis vaccine (inactivated and live) 73) Potassium Aminobenzoate 74) Porcine Insulin Zinc Suspension 75) Prednimustine 76) Porcine and Bovine insulin 77) Purified Chick Embryo Cell Rabies Vaccine 78) Pyridostigmine 79) Pneumocystis carinii IF kits 80) Prostaglandin E 1 (PGE1) 81) Radio-immunoassay kit for hormones (T3, T4, TSH Insulin, Glucogen, Growth Hormone,Cortisol, L.H., FSH and Digoxin) 82) Radioisotope TI 201 83) (a) Rabbit brains thromboplastin for PT test (b) Reagent for PT tests (c) Human Thrombin for TT tests 84) Rabies immunoglobulin of equine origin 85) Sevoflurane 86) Recuronium Bromide 87) Septopal beads and chains 88) Sodium Arsenate 89) Freeze Dried Form of Human Follicle Stimulating and Luteinising Hormones 90) Solution of Nucleotides and Nucliosides 91) Specific Desensitizing Vaccine 92) Sterile Absorbable Haemostat for control of surgical vessel bleeding 93) Strontium SR-89 Chloride 94) Suxamethonium Chloride 95) Selenium-75 96) Teicoplanin 97) Tetrofosmin 98) Ticarcillin 99) Tranexamic Acid 100) Tocainide 101) Tri-iodothyronine 102) Triethylene Tetramine 103) Thrombokinase 104) Teniposide 105) Trans-1- diamino cyclohexane Oxalatoplatinum 106) Ticarcillin Disodium and Potassium Clavulanate combination 107) Vindesin Sulphate 108) X-ray diagnostic agents, the following :- (i) Propylidone (ii) Ethyl iodophenylun decylate (iii) Iodipammide methyl glucamine (iv) Lipidoll utra fluid (v) Patent blue 109) Zalcitabine 110) Zoledronic Acid 111) Anti-Haemophilic Factor Concentrate (VIII and IX)

List 30

Part A

• Braille writers and braille writing instruments
• Hand writing equipment Braille Frames, Slates, Writing Guides, Script Writing Guides, Styli, Braille Erasers
• Canes, Electronic aids like the Sonic Guide
• Optical, Environmental Sensors
• Arithmetic aids like the Taylor Frame (arithmetic and algebra types), Cubarythm, Speaking or Braille calculator
• Geometrical aids like combined Graph and Mathematical Demonstration Board, Braille Protractors, Scales, Compasses and Spar Wheels
• Electronic measuring equipment, such as calipers, micrometers, comparators, gauges, gauge blocks Levels, Rules, Rulers and Yardsticks
• Drafting, Drawing aids, tactile displays
•  Specially adapted clocks and watches

Part B

• Orthopaedic appliances falling under heading No.90.21 of the First Schedule 
• Wheel chairs falling under heading No. 87.13 of the First Schedule

Part C

• Artificial electronic larynx and spares thereof

Part D

• Artificial electronic ear (Cochlear implant)

Part E

• Talking books (in the form of cassettes, discs or other sound reproductions) and large-print books, braille embossers, talking calculators, talking thermometers
• Equipment for the mechanical or the computerized production of braille and recorded material such as braille computer terminals and displays, electronic braille, transfer and pressing machines and stereotyping machines
• Braille paper
• All tangible appliances including articles, instruments, apparatus, specially designed for use by the blind
• Aids for improving mobility of the blind such as electronic orientation and obstacle detection
• appliance and white canes
• Technical aids for education, rehabilitation, vocational training and employment of the blind
• such as braille typewriters, braille watches, teaching and learning aids, games and other
• instruments and vocational aids specifically adapted for use of the blind
• Assistive listening devices, audiometers
• External catheters, special jelly cushions to prevent bed sores, stair lift, urine collection bags
•  Instruments and implants for severely physically handicapped patients and joints replacement and spinal instruments and implants including bone cement

How can Morulaa Help 

Morulaa specialises in Medical Device Import/Regulatory Licensee Approvals and Logistics. Our team can help you understand the Duty Structure of Import Processes for Medical Devices. Contact Morulaa HealthTech for additional consultation or information.

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