BFAD Memorandum Circular No. 7 (1992)

(NAR) VOL. III NO. 2 / APRIL - JUNE 1992

[ BFAD MEMORANDUM CIRCULAR NO. 7, April 24, 1992 ]

INCLUSION OF HEPATITIS C TESTING KITS IN LIST I-B OF DIAGNOSTIC REAGENTS REQUIRED TO BE REGISTERED

In the interest of safety and protection of the users, Hepatitis C testing kits is hereby included as No. 5 in List I-B of Memorandum Circular No. 9 s. 1991, Diagnostic Reagents Required to be Registered. Attached hereto (see below) are the updated List I-A, List I-B and List II of Medical devices. This Circular supersedes Memo Circular No. 9 s. 1991. Adopted: 24 Apr. 1992

(SGD.) QUINTIN L. KINTANAR, M.D., PH.D. Director - CESO I LIST I-A Medical Devices Required to be Registered 1. Absorbable Collagen Hemostatic Felt 2. Absorbent Cotton, sterile, and non-sterile 3. Arterial Venous Fistula Needle Set 4. Bandages with Plaster of Paris 5. Elastic Bandage 6. Band-Aid Plastic Strip Plain Pad 7. Bone Wax 8. Blood Transfusion Set 9. Catheters 10. Cervical Collar 11. Collagen 12. Condom 13. Contact Lenses (hard and soft and disposable) 14. Corset Cast 15. Cosmetic Puffs Cotton 16. Cotton Buds 17. Cotton Swabs 18. Dental Filling Alloy 19. Disposable Needles 20. Disposable Skin Stapler and Staples 21. Disposable Tissue Measuring Device22. Drainage Pouches 23. Duodenal Tube 24. Earpiercing Device 25. Endotracheal Tube 26. Exchange Transfusion Set 27. Feeding Tube 28. Filter Set 29. Fluor Alloy Amalgam 30. Gauze Pads, sterile and non-sterile 31. Humidifier Mask 32. Hypo-Allergenic Paper Tape 33. Implantable Staple 34. Infusion Administration Set 35. Intraocular Lenses 36. Intrauterine Device (IUD) 37. I.V. Catheter Needles 38. Ligating Clip Device 39. Lubricating Jelly 40. Lumbar Puncture Tray 41. Nasal Oxygen Cannula 42. Nebulizer with Aerosol Mask 43. Orthoplast Cervical Collar 44. Ostotomy set 45. Oxygen Catheter 46. Oxygen Mask 47. Peridontal Bone Grafting Implant 48. Peritoneal Dialysis Administration Set 49. Plaster 50. Porcine Heart Valve 51. Implantable Prostheses 52. Rectal Catheter 53. Rectal Tube LIST I-A Medical Devices Required to be Registered 54. Removable Skin Staple 55. Rotahalers 56. Scalp Vein Infusion Set 57. Scissors Skin Retractors 58. Skin Traction Kit 59. Spinal Anesthesia Tray 60. Stoma Bag 61. Stomach Tube 62. Suction Catheter 63. Surgical Blades, disposable 64. Surgical Gloves (Sterile and Unsterile 65. Sutures 66. Suturing Needles 67. Synthetic Cast Padding 68. Syringes 69. Thermometers70. Transfusion Set 71. Urethal Catheter 72. Urinary Drainage Tube 73. Urine Collecting Bag 74. Abdominal Pads LIST I-B Diagnostic Reagents Required to be Registered 1. HIV Testing Kits 2. Hepatitis B Testing Kits 3. Blood Typing Seva 4. Pregnancy Test Kits 5. Hepatitis C Testing Kits LIST II Products that are not Required to be Registered 1. Plastic Bags for Blood Transfusion 2. Non-sterile Surgical Facemasks 3. Surgical Caps (non-sterile) 4. Tounge Depressors 5. Non-sterile Applicator Sticks 6. Gauze (in bolts) 7. Anti Embolism Stocking 8. Undercast Padding 9. Sputum Caps 10. Rubber Stoppers 11. Aluminum Seals 12. Vials (50, 10, 5 cc) 13. Ampules (5, 10 mL amber/white) 14. Laboratory Glasswares 15. Surgical Instruments (e.g. scissors, forceps, blade-holder, needle-holder, clamps, biopsy, punches, retractors, scopes, etc.) 16. Toothbrushes 17. Dental Floss 18. Heat Solution 19. Mortuary Refrigerator 20. Abdominal Binder 21. Weighing Scale 22. Ice Bags 23. Urinal/Receptables 24. Splints 25. Plaster of Paris 26. [Abdominal Pads] - deleted by M.C. No. 9 s. 1991 27. Centrifuges and equipment 28. Anaerobic Generating System 29. X-ray Films and Chemicals 30. Surgical Face MaskSource: Supreme Court E-Library