MEDICAL DEVICE CONTROL
Regulatory Requirements for
IN THE
Medical
Devices
PHILIPPINES
Ms. Maria Cecilia C. Matienzo,
Maria Cecilia C. Matienzo
Division
Chief
Division
Chief
Medical
Center
Non-Radiation
for Device Regulation,
Device
Radiation
Regulation
Health and
Division
Research
Food andDevices
Drug Administration
Bureau of Health
& Technology
Department of Health
Department Email:
of Health
Manila, Philippines
[email protected] TOPICS
Regulatory
Brief Overview
of the FDA for
Requirements
Structure
Medical Devices
Definition of Medical Device
Different
Regulatory Controls for
Ms. Maria Cecilia C. Matienzo,
Division Chief
Medical Devices
Medical Non-Radiation Device Regulation Division
License
to Devices
Operate
Bureau of Health
& Technology
Department of Health Manila, Philippines
Certificate of Product
Registration
FDA STRUCTURE
BACKGROUND
Republic Act 3720 was enacted into law in June 1963 which is known as the Food, Drug and
Regulatory
Requirements
for
Medical
Cosmetic Act. The FDA then
was mandated to regulate the
manufacture
and distribution of
food, drugs and cosmetics.
Devices
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
Ms. Maria Cecilia C. Matienzo,
Executive
DivisionOrder
ChiefNo. 102 created the Bureau of Health Devices and Technology to regulate
medical devices among others, however no law was enacted to give the BHDT the authority
Medical
to
regulate Non-Radiation
medical devices Device Regulation Division
Bureau of Health Devices & Technology
Department
Health
Manila,
Philippines
Republic
Act No.of
9711
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
Bureau of Food and Drugs
(BFAD) with regulatory
functions over food, drugs,
medical devices, cosmetics
and household hazardous
substances
Bureau of Health Devices
and Technology (BHDT)
with regulatory functions
over radiation devices and
radiation facilities
Regulatory Requirements for Medical
Devices
Ms. Maria Cecilia C. Matienzo,
Division Chief
Medical Non-Radiation Device Regulation Division
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
FOOD AND DRUG ADMINISTRATION (FDA)
OF THE REPUBLIC OF THE PHILIPPINES
4
Regulatory Requirements for Medical
Devices
Ms. Maria Cecilia C. Matienzo,
Division Chief
Medical Non-Radiation Device Regulation Division
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
CDRRHR
Regulatory Requirements for Medical
Licensing and Regulation Division
Devices
Product Research and Standards Development
Division
Ms. Maria Cecilia C. Matienzo,
Division Chief Laboratory Support Division
Medical Non-Radiation Device Regulation Division
Bureau of HealthRadiation
Devices &
Technology
Regulation
Division
Department of Health Manila, Philippines
Major Functions of the CDRRHR
Regulation of the manufacture, import, export, distribution,
promotion,
advertisement,
and sale of medical
devices,
Regulatory
Requirements
for Medical
radiation devices, and health-related devices
Devices
Regulation of the use of radiation devices
Ms. Maria Cecilia C. Matienzo,
Health
technology
assessment of medical devices
Division
Chief
Medical Non-Radiation Device Regulation Division
Bureau of Formulation
Health Devices & Technology
Standards
Department of Health Manila, Philippines
Post Market Surveillance (Compliance Monitoring)
7
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:
Regulatory Requirements for Medical
Devices
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
of a physiological
process,
Maria
Cecilia C. Matienzo,
Ms.
supporting
Division
Chief or sustaining life,
control
of conception,
Medical
Non-Radiation
Device Regulation Division
medical&
devices,
Bureaudisinfection
of Health of
Devices
Technology
providing
information
for medical
or diagnostic purposes by means of
Department
of
Health
Manila,
Philippines
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.
What do we Regulate?
Regulatory Requirements for Medical
Medical Device Product
Devices
Medical Device Establishment (Distributor,
Importer, Wholesaler, Exporter, Manufacturer)
Ms. Maria Cecilia C. Matienzo,
Division Chief
Medical Non-Radiation Device Regulation Division
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
REGULATORY CONTROLS FOR MEDICAL DEVICES
Regulatory
Requirements
License
to Operate for Medical
CertificateDevices
of Product
Registration
Ms. Maria
Cecilia C. Matienzo,
Certificate
of Exemption
Division Chief
Medical Non-Radiation Device Regulation Division
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
10
List of Medical Devices
that Require Registration
A. Based on Memorandum Circular No. 2
16. Cotton Buds
series of 1992
17. Cotton Swabs
1. Absorbable Collagen Hemostatic Felt
2. Absorbent Cotton, sterile & non 18. Dental Filling Ally
sterile
19. Disposable Needles
3. Arterial Venous Fistula Needle Set
4. Bandages with Plaster of Paris
20. Disposable Skin Stapler and Staples
5. Bandage, Elastic
21. Disposable Tissue Measuring Device
6. Band-Aid Plastic Strip Plain Pad
22. Drainage Pouches
7. Bone Wax
8. Blood Transfusion Set
23. Duodenal Tube
Ms.
Maria
Cecilia
C.
Matienzo,
9. Catheters
24. Ear piercing Device
Chief
10.Division
Cervical Collar
25. Endotracheal Tube
11.Medical
Collagen Non-Radiation Device Regulation
Division
12. Condom
26. Exchange Transfusion Tray
Bureau
of
Health
Devices
&
Technology
13. Contact Lenses (hard and soft and
27. Feeding Tube
disposable)
Department of Health Manila, Philippines
28. Filter Set
14. Corset Cast
15. Cosmetic Puffs Cotton
29. Fluor Alloy Amalgam
30. Gauze, sterile and non-sterile
Regulatory Requirements for Medical
Devices
11
31. Humidifier Mask
46. Oxygen Mask
32. Hypo-Allergenic Paper Tape
47. Periodontal Bone Grafting Implant
33. Implantable Staple
48. Peritoneal Dialysis Administration
Set
34. Infusion Administration Set
49. Plaster
35. Intraocular Lenses
50. Porcine Heart Valve
36. Intrauterine Device (IUD)
51. Implantable Prostheses
37. I.V. Catheter Needles
52. Rectal Catheter
Ligating
Clip Cecilia
Device C. Matienzo,
38.Ms.
Maria
53. Rectal Tube
Lubricating
Jelly
39.Division
Chief
54. Removable Skin Staple
Lumbar Puncture Tray
40.Medical
Non-Radiation Device Regulation Division
55. Rotahalers
41. Nasal Oxygen Cannula
Bureau of Health Devices & Technology
56. Scalp Vein Infusion Set
42. Nebulizer with Aerosol Mask
Department of Health Manila, Philippines
57. Scissors Skin Retractors
43. Orthoplast Cervical Collar
58. Skin Traction Set
44. Ostotomy Set
59. Spinal Anesthesia Tray
45. Oxygen Catheter
60. Stomach Bag
Regulatory Requirements for Medical
Devices
12
61. Stomach Tube
B. Sterile Products
62. Suction Catheter
63. Surgical Blades, disposable
C. Implants
64. Surgical Gloves (sterile and unsterile)
D. Invasive
65. Sutures
66. Suturing Needles
67. Synthetic Cast Padding
68. Syringes
Ms. Maria Cecilia C. Matienzo,
69. Thermometers
70.Division
Chief
Transfusion Set
71.Medical
Device Regulation Division
UrethalNon-Radiation
Catheter
72.Bureau
Health Devices
UrinaryofDrainage
Tube & Technology
73.Department
of Health
Urine Collecting
Bag Manila, Philippines
74. Abdominal Pads
Regulatory Requirements for Medical
Devices
13
Checklist for the Registration of
Medical Devices
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
4. Government
attesting to the status of the
Ms.
Maria CeciliaCertificate
C. Matienzo,
manufacturer, competency and reliability of the personnel
Division
Chiefand duly authenticated by the territorial
and facilities
Medical
Non-Radiation
Device
Regulation
Divisionfor
Philippine
Consulate and/or
valid
ISO Certification
Imported
ProductDevices & Technology
Bureau
of Health
5. CertificateofofHealth
agreement
between
the manufacturer and
Department
Manila,
Philippines
trader/distributor/importer regarding the product involved.
Regulatory Requirements for Medical
Devices
14
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
Ms. Maria
Cecilia C. Matienzo,
Finished
Product.
Division
12.
Labeling Chief
materials to be used for the product: Immediate label,
box
label andNon-Radiation
package insert/
brochures,
if available.
Medical
Device
Regulation
Division
13.
Representative
sample
in the
market or commercial presentation
Bureau
of Health
Devices
& Technology
(at least one of each size)
Department of Health Manila, Philippines
14 Evidence of registration/payment (charge slip/official receipt)
15. Biocompatibility Study
16. Clinical Study
17. Risk Management
Regulatory Requirements for Medical
Devices
15
Checklist of Licensing of Medical Device Establishments
(Distributor, Importer, Wholesaler, Exporter)
Accomplished Notarized Petition Form/Joint Affidavit of Undertaking
List of Medical Device Products to be imported/distributed
Copies of Pharmacists 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
IfMs.
corporation,
registration
certificate with SEC and articles of
Maria Cecilia
C. Matienzo,
incorporation or partnership
Division Chief
If single proprietor, certificate of Business Name Registration with
Bureau
MedicalofNon-Radiation
Device
RegulationProtection
Division
Trade Regulation
and Consumer
Bureau of
Devices
& Technology
Contract
of Health
lease for
the space
of the office and storage to be occupied
any proof ofofownership
or
Department
Health Manila, Philippines
Regulatory Requirements for Medical
Devices
16
For importers:
FAA duly authenticated by the Philippine Consular Office
Regulatory
ISO/GMP of Manufacturer
Requirements for Medical
Devices
For wholesalers/exporters:
Valid contract with BFAD licensed supplier/manufacturer
Certification that products to be sold are registered with
Ms.
Maria Cecilia C. Matienzo,
BFAD
Division
LTO ofChief
local distributor/manufacturer
Medical Non-Radiation Device Regulation Division
of Health Devices & Technology
ToBureau
be presented
during inspection of establishment
Department of Health Manila, Philippines
Copies of applicable laws
Batch distribution record, product recall procedure
17
CERTIFICATE OF EXEMPTION
LTO
Regulatory Requirements for Medical
Letter ofDevices
Intent
Complete Product Line
Brochure of the Products
Ms. Maria Cecilia C. Matienzo,
CPR:
Division Chief
Medical Non-Radiation Device Regulation Division
Letter
of &Intent
Bureau of Health
Devices
Technology
Intended
use of
the Product
Department of Health
Manila,
Philippines
18
CERTIFICATES ISSUED FOR IMPORT/EXPORT
For Importation: Certificate of Non-Radiation
Regulatory Requirements for Medical
For Exportation:Devices
Certificate of Freesale
** For registrable medical device products, it
Ms. Maria Cecilia C. Matienzo,
should
Division
Chief be registered to be able us to issue the
Medical
Device Regulation Division
FreeNon-Radiation
Sale Certificate
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
19
TIMELINES
LTO
Regulatory Requirements for Medical
90 DAYS
Devices
CPR:
Ms. Maria Cecilia C. Matienzo,
180 DAYS
Division Chief
Medical Non-Radiation Device Regulation Division
COE
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
30 DAYS
20
Regulatory Requirements for Medical
Devices
Ms. Maria Cecilia C. Matienzo,
Division Chief
Medical Non-Radiation Device Regulation Division
Bureau of Health Devices & Technology
Department of Health Manila, Philippines
21
