Regulatory Requirements for. Medical Devices
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1 MEDICAL DEVICE CONTROL Regulatory Requirements for IN THE Medical PHILIPPINES Ms. Maria Cecilia C. Matienzo, Maria Cecilia C. Matienzo Division Division Chief Chief Medical Non-Radiation Device Regulation Division Bureau of Health Food and Drug Administration & Technology Department of Health Department of Health Manila, Philippines Center for Device Regulation, Radiation Health and Research
2 Brief Overview of the FDA Regulatory Requirements for Structure TOPICS Medical Definition of Medical Device Different Regulatory Controls for Ms. Maria Cecilia C. Matienzo, Medical Division Chief Medical Non-Radiation Device Regulation Division Bureau of Health & Technology Department of Health Manila, Philippines License to Operate Certificate of Product Registration
3 FDA STRUCTURE BACKGROUND food, drugs and cosmetics. Republic Act 3720 was enacted into law in June 1963 which is known as the Food, Drug and Cosmetic Act. The FDA then was mandated to regulate the manufacture and distribution of Executive Order No. 175 amended RA3720. One of the additional provision is the inclusion of the regulation of medical devices in the mandated function of BFAD to Medical regulate Non-Radiation medical devices Device Regulation Division Bureau of Health & Technology Executive Order No. 102 created the Bureau of Health and Technology to regulate medical devices among others, however no law was enacted to give the BHDT the authority Republic Act No was enacted into law in August 2009 creating the Food and Drug Administration (FDA) in the Department of Health (DOH) strengthening the regulatory authority over food, drug, cosmetics, medical devices and other health devices 3
4 Bureau of Food and Drugs (BFAD) with regulatory functions over food, drugs, with regulatory functions medical devices, cosmetics and household hazardous over radiation devices and substances Bureau of Health and Technology (BHDT) radiation facilities Bureau of Health & Technology FOOD AND DRUG ADMINISTRATION (FDA) OF THE REPUBLIC OF THE PHILIPPINES 4
5 Bureau of Health & Technology 5
6 CDRRHR Licensing and Regulation Division Product Research and Standards Development Division Laboratory Support Division Bureau of Health Radiation & Regulation Technology Division 6
7 Major Functions of the CDRRHR Regulation of the manufacture, import, export, distribution, promotion, advertisement, and sale of medical devices, radiation devices, and health-related devices Regulation of the use of radiation devices Bureau of Health & Technology Health technology assessment of medical devices Standards Formulation Post Market Surveillance (Compliance Monitoring) 7
8 MEDICAL DEVICE DEFINITION Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or Ms. Maria of a physiological Cecilia C. Matienzo, process, Division supporting Chief or sustaining life, Medical control Non-Radiation of conception, Device Regulation Division Bureau disinfection of Health of medical & devices, Technology providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body; and b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. 8
9 What do we Regulate? Medical Device Product Medical Device Establishment (Distributor, Importer, Wholesaler, Exporter, Manufacturer) Bureau of Health & Technology 9
10 REGULATORY CONTROLS FOR MEDICAL DEVICES Regulatory License Requirements to Operate for Medical Certificate of Product Registration Certificate of Exemption Bureau of Health & Technology 10
11 List of Medical that Require Registration 18. Dental Filling Ally 19. Disposable Needles A. Based on Memorandum Circular No. 2 series of Absorbable Collagen Hemostatic Felt 2. Absorbent Cotton, sterile & nonsterile 3. Arterial Venous Fistula Needle Set 4. Bandages with Plaster of Paris 5. Bandage, Elastic 6. Band-Aid Plastic Strip Plain Pad 7. Bone Wax 8. Blood Transfusion Set Bureau of Health & Technology disposable) Department of Health Manila, Philippines 9. Catheters 10. Cervical Collar 11. Collagen 12. Condom 13. Contact Lenses (hard and soft and 14. Corset Cast 15. Cosmetic Puffs Cotton 16. Cotton Buds 17. Cotton Swabs 20. Disposable Skin Stapler and Staples 21. Disposable Tissue Measuring Device 22. Drainage Pouches 23. Duodenal Tube 24. Ear piercing Device 25. Endotracheal Tube 26. Exchange Transfusion Tray 27. Feeding Tube 28. Filter Set 29. Fluor Alloy Amalgam 30. Gauze, sterile and non-sterile 11
12 31. Humidifier Mask 46. Oxygen Mask 32. Hypo-Allergenic Paper Tape Set 33. Implantable Staple 34. Infusion Administration Set 35. Intraocular Lenses 36. Intrauterine Device (IUD) 37. I.V. Catheter Needles 38. Ligating Clip Device 53. Rectal Tube 55. Rotahalers Bureau of Health & Technology 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 47. Periodontal Bone Grafting Implant 48. Peritoneal Dialysis Administration 49. Plaster 50. Porcine Heart Valve 51. Implantable Prostheses 52. Rectal Catheter 54. Removable Skin Staple 56. Scalp Vein Infusion Set 57. Scissors Skin Retractors 58. Skin Traction Set 59. Spinal Anesthesia Tray 60. Stomach Bag 12
13 61. Stomach Tube 62. Suction Catheter 63. Surgical Blades, disposable Regulatory Requirements for C. Implants Medical 64. Surgical Gloves (sterile and unsterile) 65. Sutures 66. Suturing Needles 67. Synthetic Cast Padding 68. Syringes 69. Thermometers 70. Transfusion Set 71. Medical Urethal Non-Radiation Catheter Device Regulation Division 72. Bureau Urinary of Drainage Health Tube & Technology 73. Urine Collecting Bag 74. Abdominal Pads B. Sterile Products D. Invasive 13
14 Checklist for the Registration of Medical 1. Notarized Letter of Application from Manufacturer/ Trader/Distributor 2. Valid License to Operate (LTO) of Manufacturer/Trader/Importer/Distributor/Wholesaler 3. Government Certificate of Clearance and Free Sale/Registration approval of the product from the country of origin issued by Health Authority and duly authenticated by the territorial Philippine Consulate for Imported Product Ms. 4. Government Maria Cecilia Certificate C. Matienzo, attesting to the status of the manufacturer, competency and reliability of the personnel Division and facilities Chief and duly authenticated by the territorial Medical Philippine Non-Radiation Consulate and/or Device valid Regulation ISO Certification Division for Bureau Imported of Health Product & Technology Department 5. Certificate of of Health agreement Manila, between Philippines the manufacturer and trader/distributor/importer regarding the product involved. 14
15 6. Specific Use and Directions for Use. 7. Copy of latest Certificate of Product Registration (CPR) 8. List of Amount and technical specifications of all raw materials. 9. Brief description of the methods used, the facilities and control in the manufacture, processing and packaging of the product. For sterile products, include sterilization procedure. 10. Technical specification and physical description of the Finished product. 11. Stability studies of the product and physical description of the Finished Ms. Maria Product. Cecilia C. Matienzo, 12. Division Labeling Chief materials to be used for the product: Immediate label, box Medical label and Non-Radiation package insert/ Device brochures, Regulation if available. Division 13. Bureau Representative of Health sample in the & Technology market or commercial presentation (at least one of each size) 14 Evidence of registration/payment (charge slip/official receipt) 15. Biocompatibility Study 16. Clinical Study 17. Risk Management 15
16 Checklist of Licensing of Medical Device Establishments (Distributor, Importer, Wholesaler, Exporter) Accomplished Notarized Petition Form/Joint Affidavit of Undertaking Regulatory List of Medical Device Requirements Products to be imported/distributed for Medical Copies of Pharmacist s Board of Registration Certificate, PRC ID, Valid PTR, ID Picture, Duties and Responsibilities, Certificate of attendance of the owner or pharmacist to a BFAD Seminar on Licensing of establishments Location plan and floor plan with dimensions If Ms. corporation, Maria Cecilia registration C. Matienzo, certificate with SEC and articles of incorporation or partnership If single proprietor, certificate of Business Name Registration with Bureau Medical of Non-Radiation Trade Regulation Device and Consumer Regulation Protection Division Contract Bureau of Health lease for the space & Technology of the office and storage to be occupied or Department any proof of of ownership Health Manila, Philippines 16
17 For importers: FAA duly authenticated by the Philippine Consular Office ISO/GMP of Manufacturer For wholesalers/exporters: Valid contract with BFAD licensed supplier/manufacturer Certification that products to be sold are registered with BFAD Division LTO of Chief local distributor/manufacturer Bureau of Health & Technology To be presented during inspection of establishment Copies of applicable laws Batch distribution record, product recall procedure 17
18 CERTIFICATE OF EXEMPTION LTO Letter of Intent Complete Product Line Brochure of the Products CPR: Bureau of Health Letter of & Intent Technology Department of Health Intended Manila, use of Philippines the Product 18
19 CERTIFICATES ISSUED FOR IMPORT/EXPORT For Importation: Certificate of Non-Radiation For Exportation: Certificate of Freesale ** For registrable medical device products, it should be registered to be able us to issue the Medical Free Non-Radiation Sale Certificate Device Regulation Division Bureau of Health & Technology 19
20 TIMELINES LTO 90 DAYS CPR: 180 DAYS COE Bureau of Health & Technology 30 DAYS 20
21 Bureau of Health & Technology 21
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