1. INTRODUCTION
1. INTRODUCTION
1.1. Purpose
1.1. Purpose This document provides guidance pertaining to Class A medical devices that are exempted from product registration.
1.2. Background
1.2. Background The Health Products Act (Act) and Health Products (Medical Devices) Regulations 2010 (Regulations) requires all medical devices, other than those exempted by the Regulations, to be registered with the HSA prior to placing them on the Singapore market. Medical devices are classified into one of the four risk classes (Class A to Class D) by means of classification rules set out in GN-13: Guidance on the Risk Classification of General Medical Devices and GN-14: Risk Classification of In- Vitro Diagnostic Medical Devices. Class A represents the lowest risk medical devices and Class D represents the highest risk medical devices. Class A medical devices are exempted from registration with HSA prior to placement on the Singapore market. Product registration requirement is only applicable to Class B, Class C and Class D medical devices placed on the Singapore market. All medical devices shall only be manufactured, imported and wholesaled by HSA licensed dealers. Although Class A medical devices have been exempted from the registration requirement with HSA, these medical devices shall have to conform to the Essential Principles for Safety and Performance for Medical Devices with reference to GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices and IVD Medical Devices prior to their placement on the Singapore market. Dealers are to ensure that there is a Quality Management System (QMS) in place for dealing in any Class A medical devices. For Class A medical devices supplied in a sterile state, dealers are to ensure that the sterilisation processes for any Class A sterile medical devices MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 5 of 14 conform to international standards for sterilization (such as ISO 11135, ISO 11137, ISO 17665, ISO 13408, etc) of medical devices or equivalent. The duties and obligations under Part VIII of the Act remain applicable to dealers of such devices and the manufacture, import, supply, storage, presentation and advertisement of Class A medical devices; remain under the purview of the Act and Regulations.
1.3. Scope
1.3. Scope This guidance is applicable to all Manufacturers, Importers, Wholesalers and Registrants of medical devices.
1.4. Definitions
1.4. Definitions Definitions that do not indicate they are set out in the Act or Regulations are intended as guidance in this document. These definitions are not taken verbatim from the above legislation and should not be used in any legal context. These definitions are meant to provide guidance in layman terms. MEDICAL DEVICE: means a medical device as described in the First Schedule of the Act. This includes IN VITRO DIAGNOSTIC (IVD) PRODUCT (as set out in the Regulations). REGISTRANT (as set out in the Act): in relation to a registered health product, means the person who applied for and obtained the registration of the health product under the Act. REUSABLE SURGICAL INSTRUMENT: means an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device, and which is intended to be reused after appropriate procedures for cleaning or sterilisation of the instrument have been carried out. STERILE: means, in respect of a medical device, a state free of viable micro- organisms. MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 6 of 14 MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 7 of 14
2. HOW TO USE THIS GUIDANCE
2. HOW TO USE THIS GUIDANCE This guidance is intended to assist users in identifying and understanding the requirements for Class A medical devices which are exempted from product registration. Some examples of common Class A devices are presented in Annex 1 of this document can be used as reference to guide user in determining the risk classification of the medical device in question. The annex includes a broad list of Class A device categories that have been arranged with reference to the respective risk classification rules for ease of identification. MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 8 of 14
3. DUTIES AND RESPONSIBILITIES FOR MEDICAL DEVICE
3. DUTIES AND RESPONSIBILITIES FOR MEDICAL DEVICE DEALERS
3.1. Key Regulatory Responsibilities for Dealers of Class A Medical
3.1. Key Regulatory Responsibilities for Dealers of Class A Medical Device Although Class A medical devices do not require product registration, dealers (i.e. importers, wholesalers & manufacturers) are still required to be licensed by HSA and comply with their legal duties and obligations under the Act and Regulations. Hence, dealers are required to keep distribution and complaint records, report adverse events (AE) and notify the Authority of Field Safety Corrective Actions (FSCA). For guidance on medical device AE and FSCA reporting, please refer to: • GN-05: Guidance on the Reporting of Adverse Events for Medical Devices • GN-10: Guidance on Medical Device Field Safety Corrective Action Manufacturers and importers should also ensure that their Class A medical device meets the requirements for safety, quality and effectiveness for its intended purpose. As part of the licensing requirements, manufacturers and importers are required to submit a list of their Class A medical devices electronically to HSA via R8 ► a Product Notification application in SHARE ◄. The list of Class A medical devices manufactured or imported shall be up-to-date prior to the importation of these devices and shall be updated by the licensed manufacturers and importers regularly as stipulated in the licensing conditions. This list of Class A medical devices submitted by R8 ► manufacturers and importers would be published on the “Class A Medical Device Database”, on the HSA website. Dealers are to ensure that information provided in the list are updated and accurate. ◄ MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 9 of 14
3.2. Key Regulatory Responsibilities for Presentation and
3.2. Key Regulatory Responsibilities for Presentation and Advertisements of Medical Device Dealers shall be mindful and exercise due diligence in making label claims and advertising for their products. Presentations and advertisements for the intended use of a medical device must not deviate from the Product Owner’s specifications. The product owner and manufacturer shall ensure and maintain objective evidence to substantiate the intended purpose and claims of the medical device which they are responsible for and furnish to the Authorities when requested. The presentation and advertisements should not evoke unwarranted or unrealistic expectations of product effectiveness/performance. The information presented and claims shall not be presented in a false or misleading way. Presentation and advertisement of medical devices should not contain: • False information/descriptions concerning the medical device • Misleading information that creates an erroneous impression regarding the design specification, safety, quality and efficacy or use of the device All advertisements must also comply with the Singapore Code of Advertising Practice (SCAP) drawn up by the Advertising Standards Authority of Singapore. For guidance on labelling and advertisement of medical devices, please refer to: • GN-23: Guidance on Labelling for Medical Devices • GN-08: Guidance on Medical Devices Advertisements and Sales Promotion of Medical Devices MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 10 of 14
Annex 1 — Annex 1
ANNEX 1 Examples of Class A Device Categories The following lists of Class A medical device categories have been drawn-up based on the GN-13 Guidance on Risk Classification of General Medical Devices and GN-14 Guidance on Risk Classification of IVD Medical Device. These examples are non-exhaustive and serve to only provide a reference to common Class A medical devices. Example List for Class A Medical Devices Class A General Medical Devices For the application of the risk classification rules described; please refer to GN-13 Guidance on Risk Classification of General Medical Devices S/N Examples of Device Categories (Non-exhaustive list) Applicable Risk Rules 1. Adhesive bandage, strip Rule 1 2. Adhesive tape Rule 1 3. Administration sets for gravity infusion Rule 2; Rule 4 4. Airway exchange guide Rule 5 5. Articulating paper Rule 5 6. Bags, urine Rule 4 7. Bandage, gauze Rule 1 8. Bandage, gauze, roller Rule 1 9. Bandage; self-adherent, clavicle, elastic, traction Rule 4 10. Binders; abdominal, ankle, breast, chest, sternum, wrist Rule 4 11. Bite block Rule 5 12. Blood pressure cuff Rule 4 13. Camera, dental, intra-oral (no diagnostic software) Rule 5; Rule 12 14. Cast cutter Rule 12 15. Chair and table, examination/treatment Rule 4 16. Charger, medical equipment and battery Rule 12 17. Chart, eye; amsler grid, colour discrimination, visual acuity Rule 4 18. Compression dressing, garment Rule 4 19. Corrective back brace Rule 4 MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 11 of 14 20. Cotton ball Rule 1 21. Cotton roll, general-purpose Rule 1 22. Cover, thermometer Rule 5 23. Defibrillation pads Rule 4 24. Dental dam Rule 5 25. Dental forceps Rule 5 26. Dental impression material Rule 5 27. Dental impression tray Rule 5 28. Dental placers Rule 5 29. Dental ring Rule 5 30. Dental scaler, manual Rule 5 31. Dental sectional matrix band Rule 5 32. Dental teeth protector Rule 5 33. Dental wedge Rule 5 34. Denture liner/dental cushion Rule 5 35. Depressor, tongue Rule 5 36. Dissecting scissors Rule 6 37. ECG electrodes (skin) Rule 4 38. Face barrier, resuscitation shield Rule 4 39. Gel, ultrasound, ECG Rule 4 40. Gingiva retraction cord Rule 5 41. Gloves, examination Rule 4 42. Hospital bed, general-purpose, manually- operated Rule 4 43. Hospital bed; hydraulically-powered, electrically-powered, etc Rule 12 44. Immobiliser; wrist, ankle, elbow, arm, knee, shoulder, whole body Rule 4 45. Inhaler spacer Rule 2 46. Irrigation kit, eye (without solution) Rule 2; Rule 4; Rule 5 47. Irrigator, nasal (without solution) Rule 2; Rule 5 48. Laryngoscope blades Rule 5 49. Leather components of orthopaedic appliances. Rule 14 50. Light, dental; polymerisation activator, intra-oral Rule 5; Rule 12 51. Light, examination Rule 10; Rule 12 52. Light, surgical; operating-room Rule 10; Rule 12 53. Light; headlamp, headlight, headband Rule 10; Rule 12 54. Marker, skin Rule 4 55. Mask, face Rule 4 56. Medical display screen; Rule 12 MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 12 of 14 LCD monitor, television monitor, etc. 57. Medical film processor Rule 12 58. Mirror, dental, hand-held Rule 5 59. Mirror; ENT, headband, ophthalmic, mouth, general & plastic surgery Rule 4 60. Mouth guard, preformed Rule 5 61. Nasal aspirator, manual Rule 5 62. Operating microscopes, surgical Rule 12 63. Orthosis; shoulder, elbow, wrist, hand, hip, knee, ankle, foot, finger, footwear insert, spine Rule 4 64. Orthotic footwear Rule 4 65. Patient lifts and transfer aids (Powered); transport chairs, stretchers, etc. Rule 12 66. Patient lifts and transfer aids; transport chairs, stretchers, etc. Rule 4 67. Patient restraint Rule 4 68. Percussion hammer, palpator Rule 4 69. Pressure relieving mattress/ pads Rule 4 70. Projector, visual acuity Rule 12 71. Prosthesis - external; arm, ankle, foot, elbow, hand, hip, knee, leg, shoulder, wrist Rule 4 72. Radiation shield; apron, bib, blanket, eye, thyroid Rule 4 73. Reusable surgical instruments (not intended to contact the central nervous system/central circulatory system) Rule 6 74. Self-exam pad, breast Rule 4 75. Shield; eye, face, hip, wound Rule 4 76. Sitz bath Rule 4 77. Sling bandage Rule 4 78. Software, image viewing and recording only Rule 12 79. Sphygmomanometers, aneroid, mercurial Rule 4 80. Spirometer (manual) Rule 4 81. Splint Rule 4 82. Stethoscope, mechanical Rule 4 83. Stretcher; ambulance, portable, bathroom Rule 4 84. Surgical drape, general-purpose Rule 4 85. Surgical gowns Rule 4 86. Swab Rule 4 87. Syringes (without needles) Rule 2 MEDICAL DEVICE GUIDANCE JULY 2025 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 13 of 14 88. Tourniquet strap Rule 4 89. Traction unit, non-invasive component Rule 4 90. Trial lens set Rule 4 91. Umbilical cord clamp Rule 4 92. Vaginal speculum Rule 5 93. View box, blood grouping Rule 12 94. Walking aids; crutch, frame, table, stick Rule 4 95. Wheelchairs (manual or powered) Rule 4 or Rule 12 96. X-ray cassette; digital imaging, manual Rule 4 97. X-ray film Rule 4 Class A In-vitro Diagnostic Medical Device For the application of the risk classification rules described, please refer to GN-14 Guidance on Risk Classification of IVD Medical 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 1 General culture media (non-selective) Rule 5 2 General laboratory equipment - intended and labelled as IVD; centrifuges, incubators, microscope etc. Rule 5 3 Open, standalone analyzers, equipment, machines - not intended for use in specific medical diagnostics purposes Rule 5 4 Specimen receptacles; blood, tissues, urine, etc. Rule 5 nnex REV Contact Information: Medical Devices Cluster Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg