INFORMATION ON CUSTOMS CLEARANCES FOR TRADERS FOR CLASS A MEDICAL DEVICES EXEMPTED FROM PRODUCT REGISTRATION
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1 INFORMATION ON CUSTOMS CLEARANCES FOR TRADERS FOR CLASS A MEDICAL DEVICES EXEMPTED FROM PRODUCT REGISTRATION The HS Codes required for Customs clearances, such as through the TradeNet System, are managed by the Singapore Customs. The HS Codes presented in Annex 1 is non-exhaustive and for trader s reference only. In order to determine the correct HS Code for Customs declaration purposes, please contact Singapore Customs. Non-sterile Class A medical devices are exempted from product registration. These exempted Class A medical devices under MDB controlled HS Codes are to be declared with the product code of HSAMDX Under TradeNet controls, if products are controlled by another Controlling Agency, traders are to make their Customs declarations in accordance to the requirements of these prevailing agencies. If the importer or freight forwarder is unable to find specific medical devices in these examples, please contact our MDB TradeNet office: Telephone: (65) hsa_mdb_tradenet@hsa.gov.sg Website: ces/tradenet.html Page 1 of 6
2 Annex 1 to GN-22 Revision 6, Guidance for Dealers on Class A Medical Devices Exempted from Product Registration Medical devices examples in these lists are exempted from product registration only if they are (i) Class A and (ii) supplied non-sterile. For the application of the risk classification rules described; please refer to GN-13 Guidance on Risk Classification of General Medical Devices 1) Example List for Class A General Medical Devices S/N Examples of Device Categories (Non-exhaustive list) Applicable Risk Rules HS Codes For Reference 1. Adhesive bandage, strip Rule Adhesive tape Rule Administration sets for gravity infusion Rule 2; Rule Airway exchange guide Rule Articulating paper Rule Bags, drainage/urine collection Rule Bandage, gauze Rule Bandage, gauze, roller Rule Bandage; self-adherent, clavicle, elastic, Rule traction 10. Binders; abdominal, ankle, breast, chest, Rule sternum, wrist 11. Bite block Rule Blood pressure cuff Rule Camera, dental, intra-oral (no diagnostic software) Rule 5; Rule Cast cutter Rule Dentists Chair and parts there of: Chair and table, Rule 4 Other Similar Chairs examination/treatment excluding dentists chairs: Medical Surgical Dental Page 2 of 6
3 or Veterinary Furniture incl parts there of excl chairs: Charger, medical equipment and battery Rule Chart, eye; amsler grid, colour discrimination, Rule visual acuity 18. Compression dressing, garment Rule Corrective back brace Rule Cotton ball Rule Cotton roll, general-purpose Rule Cover, thermometer Rule Defibrillation pads Rule Dental dam Rule * 25. Dental forceps Rule * 26. Dental impression material Rule Dental impression tray Rule * 28. Dental placers Rule * 29. Dental ring Rule * 30. Dental scaler, manual Rule * 31. Dental sectional matrix band Rule * 32. Dental teeth protector Rule * 33. Dental wedge Rule * 34. Denture liner/dental cushion Rule * 35. Depressor, tongue Rule Drill guide system Rule ECG electrodes (skin) Rule Face barrier, resuscitation shield Rule Gel, ultrasound, ECG Rule Gingiva retraction cord Rule Gloves, examination Rule Hospital bed, general-purpose, manually-operated Rule Hospital bed; hydraulically-powered, electricallypowered, Rule etc 44. Hot/Cold pack Rule Immobiliser; Rule Page 3 of 6
4 wrist, ankle, elbow, arm, knee, shoulder, whole body 46. Inhaler spacer Rule Irrigation kit, eye (without solution) Rule 2; Rule 4; Rule Irrigator, nasal (without solution) Rule 2; Rule Laryngoscope blades Rule Leather components of orthopaedic appliances. Rule Light, dental; polymerisation activator, intra-oral Rule 5; Rule Light, examination Rule 10; Rule Light, surgical; operating-room Rule 10; Rule Light; headlamp, headlight, headband Rule 10; Rule Marker, skin Rule Mask, face Rule Mask, resuscitation Rule Medical display screen; LCD monitor, television monitor, etc. Rule Medical film processor Rule Microscope instrument set Rule Mirror, dental, hand-held Rule * 62. Mirror; ENT, headband, ophthalmic, mouth, Rule general & plastic surgery 63. Mouth guard, preformed Rule * 64. Nasal aspirator, manual Rule Operating microscopes, surgical Rule Orthosis; shoulder, elbow, wrist, hand, hip, knee, ankle, foot, finger, footwear Rule insert, spine 67. Orthotic footwear Rule Patient lifts and transfer aids (Powered); Rule transport chairs, stretchers, etc. 69. Patient lifts and transfer aids; transport chairs, stretchers, etc. Rule Page 4 of 6
5 70. Patient restraint Rule Percussion hammer, palpator Rule Pressure relieving mattress/ pads Rule Projector, visual acuity Rule Prosthesis - external; arm, ankle, foot, elbow, hand, hip, knee, leg, shoulder, wrist Radiation shield; apron, bib, blanket, eye, thyroid Rule 4 Joints: Other Parts of the body: Rule Retinal camera Rule Reusable surgical instruments (not intended to contact the central nervous system/central circulatory system) Rule Self-exam pad, breast Rule Shield; eye, face, hip, wound Rule Sitz bath Rule Sizer templates Rule Sling bandage Rule Software, image viewing and recording only Sphygmomanometers, aneroid, mercurial Rule 12 Rule Spirometer (manual) Rule Splint Rule Stethoscope, mechanical Rule Stretcher; ambulance, portable, bathroom Rule Surgical drape, general-purpose Rule Surgical gowns Rule Swab Rule Based on intended use of software 92. Syringes (without needles) Rule / Tourniquet strap Rule Traction unit, non-invasive component Rule Trial lens set Rule Umbilical cord clamp Rule Vaginal speculum Rule Page 5 of 6
6 98. View box, blood grouping Rule Walking aids; crutch, frame, table, stick Rule Wheelchairs (manual) Rule Wheelchairs (powered) Rule X-ray cassette; digital imaging, manual Rule X-ray film Rule * controlled by another Controlling Agency 2) Example List for Class A In-Vitro Diagnostic (IVD) Devices NOTE Any product for general laboratory use not manufactured, sold or represented for use in specified in vitro diagnostic applications are not deemed to be IVD medical devices. S/N Examples of Device Categories (Non-exhaustive list) Applicable Risk Rules HS Codes For Reference 1 General culture media (non-selective) Rule / General laboratory equipment - intended and labelled as IVD; Rule centrifuges, incubators, microscope etc. 3 Open analyzers, equipments, machines - intended for use with any brands of test kits/reagents from other product owners for Rule IVD purpose Specimen receptacles; Rule 5 Blood collection blood, tissues, urine, etc. tubes Page 6 of 6
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