1. Class a notification Maria cecilia c. matienzo PAMDRAP 12TH GMM 2017
Division chief, center for device regulation, radiation health, and research
28 February 2017
PAMDRAP 12TH GMM 2017

2. tOPICS Definition of Medical Device Classification of Medical Device
Requirements for Class A Medical Device
Sample of Class A Medical Device
Questions
PAMDRAP 12TH GMM 2017

3. DEFINITION OF MEDICAL DEVICE
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 of a physiological process,
supporting or sustaining life,
control of conception,
disinfection of medical devices,
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.
PAMDRAP 12TH GMM 2017

4. Classification of medical devices (based on the harmonized classification based on the asean medical device directive)
Class A – Low Risk
Class B – Low-Moderate Risk
Class C – Moderate-High Risk
Class D – High Risk
PAMDRAP 12TH GMM 2017

5. REQUIREMENTS FOR CLASS A NOTIFICATION legal requirements
Notarized Application Form (Annex A or B)
Payment
Copy of Letter of Authorization. For imported medical devices, the copy of the Letter of Authorization shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the authorization is true and correct.
A government – issued certificate attesting to the status of the Manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO For imported medical devices, the copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
PAMDRAP 12TH GMM 2017

6. Continuation…. Legal requirements
For imported medical devices, the Certificate of Product Notification, Certificate of Product Registration, or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency or accredited notified body in the country of origin. The copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
Colored picture of the device from all sides. However, the CDRRHR can require a representative sample or commercial presentation for verification purposes.
PAMDRAP 12TH GMM 2017

7. Requirements for class a notification technical requirements
Device description consisting of the following:
Intended use
Instruction for use
List of all raw materials
Technical specification of the finished product
List of reference codes, sizes, colors, models and variance, whichever is applicable.
PAMDRAP 12TH GMM 2017

8. Continuation….. technical requirements
Certificate of Conformity (issued by government agency dealing with metrology) on the aspect of manufacture relating to metrology for devices with measuring functions, if applicable
Declaration of Conformity (self declaration by the manufacturer) with product standards, if applicable
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9. Continuation….. Technical requirements
Clear and complete colored pictures of label from all sides of the packaging (loose label or artworks of all layers of packaging)
Declaration of shelf life
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10. Examples of medical device under class a
KEYWORD
DESCRIPTION
Adhesive
Adhesive Strip
Adhesive , Denture, OTC
Adhesive, Liquid
Closure, Skin, Adhesive Strip
Prosthesis, Adhesive, External
PAMDRAP 12TH GMM 2017

11. KEYWORD DESCRIPTION Amalgamator Amalgamator, Dental, AC-powered
Analyzer
Analyzer, Visual Function
Analyzer, Distribution, Weight, Podiatric
Analyzer, Gait
Analyzer, Spectrum, Electroencephalogram (EEG) Signal
Airway
Airway, Nasopharyngeal
Airway, Obstruction Removal (Choke Saver)
Resuscitator, Emergency, Protective, Infection
PAMDRAP 12TH GMM 2017

12. KEYWORD DESCRIPTION Bag Bag, Bile Collecting
Bag, Drainage, with Adhesive, Ostomy
Bag, Enema
Bag, Stomal
Bag, Urinary Collection
Bag, Urinary, Ileostomy
Bag, Urine Collection, Leg, for External Use
Apron
Apron, Conductive
Apron, Leaded
Apron, Protective
Arm
Prosthesis, Arm
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13. KEYWORD DESCRIPTION Bandage Adhesive Strip
Adhesive Tape and Adhesive Bandage
Bandage, Binder, Elastic
Bandage, Cast
Bandage, Gauze
Bandage, Pressure
Bandage, Traction
Fiber, Medical, Absorbent
Post-Surgical Compression Garments/Bandages
PAMDRAP 12TH GMM 2017

14. KEYWORD DESCRIPTION Bassinet Bassinet (Infant Bed) Bath
Bath, Hydro-Massage
Bath, Sitz
Bead
Beads, Hydrophilic, for Wound Exudate Absorption
Bed
Bed, AC-powered Adjustable Hospital
Bed, Birthing
Bed, Hydraulic, Adjustable Hospital
Bed, Manual
Bed, Patient, Rotation, Manual
Bed, Pediatric Open Hospital
Bedrail
Unit, Traction, Static Bed
PAMDRAP 12TH GMM 2017

15. KEYWORD DESCRIPTION Binder Bandage, Binder, Elastic Binder, Abdominal
Binder, Breast
Binder, Perineal
Binder, T
Binder, Wrist
Belt
Band or Belt, Pelvic Support
Belt, Abdominal
Belt, Lumbosacral
Belt, Pelvic, Traction
Belt, Rib (Support)
Support, Hernia
Truss, Umbilical
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16. KEYWORD DESCRIPTION Camera Camera, Still, Endoscopic
Camera, Still, Surgical
Camera, Television, Microsurgical, without Audio
Camera, Television, Surgical, without Audio
Camera, Video
Surgical Cameras and Accessories
Cane
Cannula
Cannula, Ear
Cannula, Eye, Cyclodialysis
Cap
Cap, Surgical
Cap, Tip, Syringe
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17. KEYWORD DESCRIPTION Chair Chair, Birthing Chair, Dental
Chair, Dental with Operative Unit
Chair, Dialysis, Powered, without Scales
Chair, Dialysis, Unpowered, without Scales
Chair, Examination and Treatment
Chair, Geriatric
Chair, Neurosurgical
Chair, Operative, without Unit
Chair, Ophthalmic, AC-powered
Chair, Ophthalmic, Manual
Chair, Pneumoencephalographic, Radiographic
Chair, Podiatric
Chair, Posture, for Cardiac and Pulmonary Treatment
Chair, Rehabilitation
PAMDRAP 12TH GMM 2017

18. KEYWORD DESCRIPTION Drape Drape, Microscope, Ophthalmic
Drape, Patient, Ophthalmic
Drape, Surgical
Drape, Surgical, ENT
Pack, Surgical Drape
Sheet, Drape
Sheet, Drape, Disposable
Dressing
Dressing, Aerosol
Dressing, Nonadherent
Dressing, Periodontal
Kit, Dressing
Pad, Dressing
PAMDRAP 12TH GMM 2017

19. KEYWORD DESCRIPTION Film Device, Spot Film Film, X-ray
Film, X-ray Cassette
Film, X-ray, Dental, Intraoral
Filter
Filter, Aspirator
Filter, Kidney Stone
Forceps
Forceps, Approximation
Forceps, Articulation Paper
Forceps, Disconnect
Forceps, Dressing
Forceps, Dressing, Dental
Forceps, ENT
Forceps, Fixation
Forceps, Gallbladder (Biliary Duct)
Forceps, General & Plastic Surgery
Forceps, Hemostatic
Forceps, Intestinal (Clamps)
Forceps, Lung
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20. KEYWORD DESCRIPTION Instrument Instrument Set for Orthopedic Surgery
Instrument, Dental, Manual
Instrument, Manual, Specialized Obstetric-Gynecologic
Instrument, Microsurgical
Instrument, Orthodontic
Instrument, Periodontal
Instrument, Surgical, Non-Powered
Kit, Instruments and Accessories, Surgical
Microsurgical Instrument
Orthopedic Manual Surgical Instrument
Set, Instrument for Dental Surgery
Set, Instrument for Middle Ear Surgery
Set, Instrument, Podiatry
Surgical Instruments, G-U, Manual (and Accessories)
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21. KEYWORD DESCRIPTION Lamp Activator, Ultraviolet, For Polymerization
Lamp, Endoscope, Incandescent
Lamp, Examination (Light)
Lamp, Operating Room
Lamp, Surgical
Lamp, Surgical, Incandescent
Latex
Sheath, Corrugated Rubber, for Nonindwelling Catheter
Lead
Apron, Protective
Shield, X-ray
Shield, X-ray, Portable
Leg
Prosthesis, Leg
Legging
Non-Inflatable Compression Legging
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22. KEYWORD DESCRIPTION Saw Saw, Laryngeal Saw, Manual and Accessories
Saw, Nasal
Saw, Wire
Scale
Scale, Infant
Scale, Surgical Sponge
Scaler
Scaler, Periodontic
Scissors
General Use Surgical Scissors
Medical Disposable Scissors
Scissors for Cytoscope
Scissors, Bandage/Gauze/Plaster
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23. KEYWORD DESCRIPTION Syringe Syringe, Oral (Medication Dispenser) Table
Table, Examination/Treatment
Table, Mechanical
Table, Nuclear Medicine
Table, Obstetrical, AC-powered (and Accessories)
Table, Obstetrical, Manual (and Accessories)
Table, Powered
Table, Radiographic, Non-Tilting, Powered
Table, Radiographic, Stationary Top
Tape
Adhesive Tape and Adhesive Bandage
Tape, Adhesive
Tape, Adhesive, Hypoallergenic
Tape, Adhesive, Waterproof
Tape, Cotton
Tape, Measuring, Rulers and Calipers
Tape, Nystagmus
Tape, Orthopedic
PAMDRAP 12TH GMM 2017

24. KEYWORD DESCRIPTION Tester Tester, Color Vision Thermal
Thermal Wear, Therapeutic
Thermometer
Kit, Thermometer
Strip, Temperature, Forehead, Liquid Crystal
Wheelchair
Wheelchair, Mechanical
Wheelchair, Powered
Wheelchair, Stair Climbing
Tubing
Dental Unit, Tubing and Accessories
Tubing, Noninvasive
Tubing, Plastic
Toothbrush
Toothbrush, Manual
Tourniquet
Stereoscope
Stereoscope, Battery-powered
Stethoscope
Stethoscope, Fetal
Stethoscope, Mechanical
Stocking
Stocking, Elastic
Stocking, Medical Support
PAMDRAP 12TH GMM 2017

25. KEYWORD DESCRIPTION Speculum Speculum, Nasal Speculum, Non-Illuminated
Speculum, Rectal
Speculum, Vaginal, Metal
Speculum, Vaginal, Metal, Fiberoptic
Splint
Intranasal Septal Splint
Splint, Abduction, Congenital Hip Dislocation
Splint, Abduction, Shoulder
Splint, Clavical
Splint, Denis Brown
Splint, Extremity, Inflatable, External
Splint, Extremity, Noninflatable, External
Splint, Hand, and Components
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26. PAMDRAP 12TH GMM 2017

27. FOR YOUR ATTENTION
PAMDRAP 12TH GMM 2017