English — official text

Appendix A — Appendix A

APPENDIX A A reference list of acceptable product claims for some examples of Class A medical devices that are exempted from product registration*. (*The classification of Class A medical devices should be in accordance with relevant Guidance Documents e.g. GN-13 or GN-14. The examples given below should not be used as a reference for classification of medical devices. For information on classification of medical devices, please refer to other Guidance Documents available on our website (www.hsa.gov.sg).  GN-13 Guidance on Risk Classification of General Medical Devices  GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices  GN-22 Guidance for Dealers on Class A Medical Devices exempted from Product Registration) Examples of Class A medical devices* Acceptable product claims 1 Adhesive bandage / dressing / strip / tape  cover and protect intact skin or wounds  approximate the skin edges of a wound  support an injured part of the body  fix dressings to skin  bind/attach/secure objects to the skin/body part  additional properties where substantiated e.g. waterproofing 2 Adhesive tape remover  remove adhesive tape and its residue from the skin or other surfaces 3 Nasal aspirator, manual  enable gentle suction and clearing of excessive mucus from the nasal passages to facilitate easier breathing 4 Ice bag / collar  provide dry cold therapy to a limited external surface area of the body  alleviate pain and/or promote healing in minor injuries of the body 5 Bandage, self- adherent  secure a dressing  maintain pressure over a compress immobilise a limb or other body part 6 Bandage, clavicle  maintain fixation and longitudinal extension of the clavicle during a period of treatment 7 Bandage, elastic  provide support or local pressure to a part of the body, especially a joint, while allowing movement 8 Bandage, gauze cover and protect wounds 9 Bandage, gauze, roller  bandage heads, limbs, and difficult to dress wounds (e.g., burns, plastic surgery, or orthopaedic wounds) 10 Bandage, traction  assist in exerting desirable tensile (pulling) forces on the body MEDICAL DEVICE GUIDANCE________________________________________________________JUNE 2018 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 15 of 17 Examples of Class A medical devices* Acceptable product claims 11 Bedpan  receptacle for urine and faeces 12 Abdominal / ankle / breast / chest / sternum / wrist binder  support relaxed abdominal walls / ankle joint / breasts / ribs and chest / sternum / wrist joint 13 Blanket, general purpose  wrap or cover a person for warmth and comfort 14 Bottle, heating / cooling  filled with either hot or cold water or ice for the purpose of applying heat or cold therapy to an area of the body 15 Contact lens case  for the storage of contact lenses when the lenses are not being used 16 Chair, bath / shower  to be sat upon by a person who is either bathing, showering, or using some washing facility 17 Chair, toilet  allows an immobilised person/patient to utilise a standard stationary toilet without leaving the chair 18 Compression dressing  compress a local area, e.g., to stop bleeding, prevent oedema  provide support for varicose veins or ostomy aids 19 Compression garment  fit over and apply pressure to a specific body part(s) (e.g., thighs, hips, buttocks)  may aid in the readjustment of overlying skin, after significant subcutaneous tissue removal (e.g., fat removal after liposuction) 20 Cotton ball  apply medications to or remove liquid from various parts of the body 21 Cover, thermometer  prevent cross-contamination between patients and/or environmental exposure 22 Gloves, examination  prevent contamination between patient and examiner 23 Heat / cold pack  provide cold/hot therapy to body surface and/or underlying tissue, e.g. muscle 24 Mask, Face  prevent contamination to patient/ health care personnel 25 Pressure alleviation pad  prevent pressure sores, e.g. bed sores or decubitus ulcers occurring on the parts of the patient's body which are prone to this 26 Finger protector  protect an injured finger from further trauma during the healing process 27 Protector, foot (e.g. Bunion / Callus / Corn protectors, pads, plasters)  protect that part of the foot from friction against surfaces and knocks against objects  may have additional properties (e.g. waterproof, lubricating, hypoallergenic) where substantiated 28 Patient restraint  temporarily secure the arm or leg of an adult patient to prevent injury or hazards. when MEDICAL DEVICE GUIDANCE________________________________________________________JUNE 2018 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 16 of 17 Examples of Class A medical devices* Acceptable product claims anchored to a fixture or furniture part (e.g., a bedrail)  restrict movement of the patient and prevent the patient from interfering with treatment 29 Restraint, fingers  restrict finger mobility and prevent potential injury 30 Restraint, body  secure a patient's arms to the torso to prevent self-inflicted injury 31 Self-exam pad, breast  used as an aid in performing breast self- examination 32 Orthotic shoe  support, align, prevent, or correct deformities of the feet to help improve their function 33 Cast boot boot-like cover for a foot enclosed in a leg cast 34 Shoe, Cast  protect the cast material and provide support 35 Sling  support and limit the range of motion of an injured limb during the healing period  support and limit the range of motion of a body in transport 36 Splint immobilise an injured body or body part 37 Splint, nasal, external  immobilisation of parts of the nose typically after a fracture or treatment  may function as a truss-like support on the outside of the nose 38 Cast stockinette  used as padding under a cast or splint 39 Stocking, stockinette  hold bandages in place  place uniform pressure on a leg, finger, arm, or other part of an extremity  pad the area under a cast or splint cover a stump when a prosthesis is worn 40 Stocking, medical support  support, correct, prevent deformity, or to align body structures for functional improvement 41 Tourniquet strap  compress the arteries and regulate the blood flow 42 Transfer aid, person  assist in the physical transfer of a person/patient, e.g. ill, disabled or infirm, from one position to another 43 Walking crutch / frame / table / stick  assist a disabled or infirm user in walking by providing a means of support and increasing their ability to move around without attendance from another person 44 Wheel Chair  wheeled personal mobility device for a disabled user not having the full capacity to walk by him or herself CONTACT INFORMATION Medical Advertisement & Compliance Monitoring Unit Vigilance & Compliance Branch Vigilance, Compliance & Enforcement Cluster Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-01 Helios Singapore 138667 Tel: 6866 1111 Fax: 6478 9038 Email: HSA_MA@hsa.gov.sg Website: www.hsa.gov.sg