In the Philippines, the Medical Device and Diagnostic Kits is registered under the Center for Device Regulation, Radiation Health and Research (CDRRHR) at the Department of Health (DOH). The CDRRHR conduct appropriate test for the products and evaluates them to ensure the safety, quality, and effectiveness of the product for the users.
Here is the list of Medical Device that is required to be registered.
List of Medical Devices:
- Absorbable Collagen Hemostatic Felt
- Absorbent Cotton, sterile and non-sterile
- Arterial Venous Fistula Needle Set
- Bandage with Plaster of Paris
- Bandage, Elastic
- Band-Aid Plastic Strip Plain Pad
- Bone Wax
- Blood Transfusion Set
- Catheters
- Cervical Collar
- Collagen
- Condom
- Contact Lenses (hard and soft and disposable)
- Corset cast
- Cosmetic Puffs Cotton
- Cotton Buds
- Cotton Swab
- Dental Filling Ally
- Disposable Skin Stapler and Staples
- Disposable Tissue Measuring Device
- Disposable Needle
- Drainage Pouces
- Duodenal Tube
- Earpiercing Device
- Endotracheal Tube
- Exchange Transfusion Tray
- Feeding Tube
- Filter Set
- Fluor Alloy Amalga
- Gauze, sterile and non-sterile
- Humidifer mask
- Hypo-allergenic paper tape
- Implantable Staple
- Infusion Administration Set
- Intraocular Lenses
- Intrauterine Device (IUD)
- I.V. Catheter Needle
- Ligating Clip Device
- Lubricating Jelly
- Lumbar Puncture Tray
- Nasal Oxygen Cannula
- Nebulizer with Aerosol Mask
- Orthoplast Cervical Collar
- Ostotomy Set
- Oxygen Catheter
- Oxygen Mask
- Periodontal Bone Grafting Implant
- Peritoneal Dialysis Administration Set
- Plaster
- Porcine Heart Valve
- Implantable porstheses
- Rectal Catheter
- Rectal Tube
- Removable Skin Staple
- Rotahalers
- Scalp Vein Infusion Set
- Scissors Skin Retractors
- Skin Traction Set
- Spinal Anesthesia Tray
- Stomach Bag
- Stomach Tube
- Suction Catheter
- Surgical Blades, Disposable
- Surgical Gloves (sterile and unsterile)
- Sutures
- Suturing Needles
- Synthetic Cast Padding
- Syringes
- Thermometers
- Transfusion Set
- Urethal Catheter
- Urinary Drainage Tube
- Urine Collecting Bag
- Abdominal Pads
Triple i Consulting Specialist can help you in the process and preparation of your documents for registration. Please contact us at info@tripleiconsulting.com and our FDA Consulting Specialist will assist you with any questions you may have.
