Republic of the Philippines FOOD AND DRUG ADMINISTRATION FDA CIRCULAR No. 209,0-00}-A, TO: SUBJECT Department of Health (04 JAN 2021, ALL__MEDICAL DEVICE _MANUFACTURERS. TRADERS, DISTRIBUTORS AND OTHER CONCERNED PARTIES Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements” To clarify the classification and update the list of medical devices that are required to be registered with the Food and Drug Administration (FDA) as part of the initial implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Me Requirements”, Annex A of FDA Circular No, 2020-001 is hereby amended as follows: al Device Based on the ASEAN Harmonized Technical ITEM FROM __- : Se NAME OF MEDICAL \cLASS NAME OF MEDICAL CLASS ee ___ DEVICE ae DEVICE 1 ABSORBABLE ABSORBABLE HEMOSTATIC HEMOSTATIC AGEN AGENTS a nan Sap eeeble Deneetat® a. Absorbable Hemostatic Agents, ie Based Agents Non-Collagen | cD | Non-Collagen Based | 2. | ADHESIVE (ALL TYPES) a._ Adhesive Tape b._ Adhesive Bandage b, Absorbable Hemostatic | Agents, Collagen Based b. Absorbable Hemostatic Agents, CID | “Collagen Based Re ‘A_| ADHESIVE A aa Civic Drive Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line + 63 2 857 1900 Website: www.fda.gov.ph Fax +63 2.807 0751 Email: [email protected]3) || ADMINISTRATIONS ae SET (ALL | SYSTEM ye / DELIVERY S" TEM | a. With needle B__|a. With needle _ B b. Without needle HH ©. Without needle I b.1. Fluid/Medicine/ AB b.1. Fluid/Medicine/Parenteral Parenteral Nutrition L Nutrition b.1.a. Not for connection to an active medical | device; intended for channeling or storing body liquids or | tissues, liquids or gases b.1.b If for connection to an active medical device; for use of | channeling blood, or | storing or channeling | 5 | other body liquids, | or for storing organs parts of organs or body tissues: if | surgically invasive for transient? or short® term use }.2. Blood/Body Liquids! 2. Blood/Body Liquids B Gases 7 fcrppee thera eeeeeeee . 4 | BANDAGE a a. All types A_| BANDAGE A ___ |b. Self Adhering Wrap A | 3 | BONE WAX cD s and/or derivatives | rendered non-viable c or cells, tissues and/or | | | derivates of microbial or recombinant origin | b. Contains animal cells, tissues |_| | and/or derivatives thereof, rendered non-viable or cells, | py tissues and/or derivates of | microbial or recombinant | | oresee tint i. |. angen 6 | BURR, DENTAL AIB | BURR, DENTAL) SURGICAL/ORTHOPEDIC |_SURGICAL/ORTHOPEDIC a Reusable Bie ». Single use8 10 n 7 | CANNULA (ALL TYPES) aires a, Reusable A b. In contact the D CNS! and CCS? | ©. Through body orifice Bi Cc ice He | ong’ term ws & Short term use, Single | CANNULA (ALL TYPES) er a. Reusable x A b. In contact with the CNST and Cost ¢. Through body orifice ¢.2 Short’ term & Short term use, Single use, |__use, Disposable use Disposable use - | CATHETER (ALL Be CATHETER (ALL TYPES) Hi B_| a. Short’ term use eB nu | C |b. Long’ term use c ¢. Through body orifice | A,B, |_c. Through body orifice | c c.1 Transient’ use A | B | =a 4 In contact with the CNS! and CCS? Bi ae 2 | CEMENT CEMENT, DENTAL/BONE DENTAL/BONE a. Cement, Dental B_|-a Cement, Dental B |b. Cement, Bone Synthetic | C/D |b. Cement, Bone Synthetic | _C [-e. Cement, Bone Natural | D_| c. Cement, Bone Natural D | CLIP CLP a. Invasive except those touching | ¢ a. Invasive 6 b. Invasive, touching CNS" and 5 ccs? I [LAT cNon-invasive CLOSURE DEVICE; CLOSURE DEVICE; SKIN SKIN STAPLER STAPLER (INCLUDING | (INCLUDING REMOVER) REMOVER) _ a. Non invasve_ —_ |B _| a. Non invasive B b. Invasive wasive except those touching | cD D CONICALICORNEAL | BIC RING SEGMENT a. Endovascular Coil . Neurovascular Coil a, Vascular Coil b. Endovascular Coil/Neurovascular Coil | CONICAL/CORNEAL RING SEGMENT a, Short’ term use ace b.Long'termuse TC[ 14] CYTOLOGY BRUSH CYTOLOGY BRUSH (Biopsy. PS aay ene neral & Plastic Surgery) Plastic Surgery) E “a. Body orifice ‘a. Body orific A [[b. Surgically Invasive b. Surgically hi B ps ee ccs DENTAL RESTORATIVE ; MATERIAL | a. Transient® use, not absorbed by A | H | mucus membrar =e | ERE Verma NB», short term or long" term use B | Suspension ere 16 | DISSECTOR [NEEM] DISSECTOR a) ‘A. Reusable “A_| A.Reusable A B. Single Use B_|B. Single Use al 17 _| FILTER (to filter bacterial |B | FILTER (to filter bacterial and/or and/or viral cross viral cross contamination which contamination which will will be introduced to the patient) be introduced to the a. Intended to filter pathogens A patient) b. Intended to filter liquids and a gases 18 | GLOVES i, GLOVES aa “ — Non-sterile | 4 | a, Examining, Non-sterile gloves. | A gloves Beal ___|b. Surgical, Sterile Gloves | B_ J b. Surgical, Sterile Gloves B 19 GRAFT a. Absorbable D c 20 | IMPLANTABLE C/D IMPLANTABLE PROSTHESIS I PROSTHESIS a. Not in direct contact with the a heat BCS? | b, In direct contact with the heart, |p) CNS! and CCS? ¥ 21 | LUBRICATING LUBRICANT/TRANSMISSION GEUJELLY GELJELLY a. External A__| a. External EAs) b. Internal ‘A_| b. Internal B 22 | MASK (silicone B | MASK ei) facemask, full mask, a. Mask - used to protect against anesthesia, oxygen) respiratory pathogens (face | for channeling or storing body | liquids or tissues, liquids or gases (oxyger | . Mask - used in the channeling of connected to an active device (anesthesia, oxygen, ete.) gases, drugs or medicine and _23 | NEEDLE (All types, NEEDLE (ALL TYPES, EXCEPT except for tattoo and FOR TATTOO AND acupuncture) ACUPUNCTURE) a. Except those touching CNS" and ccs? b. Touching CNS! and CCS? 24 | OPHTHALMIC B/D | OPHTHALMIC VISCOELASTIC VISCOELASTIC = DEVICE al cells, and/or derivatives thereof, rendered non-viable or cells, tissues and/or derivates of microbial or recombinant origin tains animal cells, tissues and/or derivatives thereof, | rendered non-viable or cells, | -D. | tissues and/or derivates of | | ib microbial or recombinant origin 25 | ORTHOPAEDIC WIRE | B/C | ORTHOPAEDIC WIRE ay B ‘a. Short® term use |__| b. Long® term use | 26 | PERCUTAENOUS B_ | PERCUTAENOUS RETRIEVAL RETRIEVAL DEVICE | DEVICE | a. Except those touching CNS! and B (ec fi b. Touching CNS" and CCS* ) 27 | PLASTER/PLASTIC ‘a. | PLASTER/PLASTIC STRIP HH | STRIP (ALL TYPES) (ALL TYPES) eo a. Gauze |_A_| a Plaster 7 eae [/b. Gauze, intemal sponge |B | b. Plaster with medicine ia Lei acne uae Sa medicine ain ial 2B c. Plaster with biologic | [28 [RECONSTRUCTION | B/C | RECONSTRUCTION KIT/DEVICE; | KIT/DEVICE: FIXATION DEVICE _| DEVICE | |_a Reusable aa a | | Shor? temuse SB eee ead c. Long* term use 7 (a 29 | SILICON OIL IN VIAL SILICON OIL (INTRAOCULAR | C FOR OPHTHALMIC FLUID) USE Be if30 SURGICAL MESH c SURGICAL MESH a. Does not contain animal cells, tissues and/or derivatives thereof, rendered non-viable or cells, tissues and/or derivates of |__ microbial or recombinant origi ’. Contains animal cells, tissues | and/or derivatives thereof, rendered non-viable or cells, tissues and/or derivates of a microbial or recombinant origin 31 | TUBE, Other Types ‘AB | TUBE (ALL TYPES) | a. Not connected to an active device b. Connected to an active device | B Furthermore, the following products shall be added in the list of medical devices in Annex A: |_NAME OF MEDICAL DEVICE CLASS 1 |_RESUSCITATOR [a Manually Controlled z A [b. Automatic Controlled i B 2 | VENTILATOR Cc ‘The classification of the following medical devices included in Annex A shall remain the same and shall not be affected by th coc LIST OF MEDICAL DEVICE CLASS 1_| ABDOMINAL PAD oa A 2 ACCESS/INJECTION PORTS 5 c 3__|_ ACETABULAR e c LL 4 ADAPTOR/CONNECTOR (ALL TYPES) A [3 | ANCHOR, PREFORMED A 6 _| ANESTHESIA SET ie 7_|_ANNULOPLASTY RING D 8 APHERESIS KIT/ CELL SEPARAT ION KIT B > ARTIFICIAL SALIVA. A 10_| BASE PASTE A 11_|_ BIOPSY NEEDLE/INSTRUMENT (ALL TYPES) B BLOODBAG ECR BLOOD TRANSFUSION SET/KIT B 14_| BONE MARROW COLLECTION/ TRANSFUSION KIT B 15_ [BREATHING CIRCUIT B 16_|_CAP (DISINFECTION, SEAL, TAPER, DEAD END) Aaa 17 CARDIOTOMY RESERVOIR B | 18_| CAVITYLINER B_| 19 | CENTRAL VENOUS BLOOD PRESSURE KIT D20_[_CERVICAL COLLAR [suae 21_| CHEST DRAINAGE KIT B a. Active type [SEBS rs b. Analog type (Except mercurial type) as A 23° |_CLIP APPLIER aE: ma a. Reusable i: A b. Single use i B 24_| COLLAGEN i D 25 | CONDOM i a) | [a Condom (Ail types) a Cc |b. Condom with spermicide TED) __|e. Condom - Natural Membrane -D 26_| CONTACT LENS SOLUTION ci Ge | 27_[ CONTACT LENS, INCLUDING COSMETIC CONTACT _ iz LENSES | 28_| CORSET CAST Aaa 29 | COTTON (medical/hospital use) i aanstesins|| a. Cotton. : A b. Paddie, Cottonoid c B 30_|_ DIALYSATE CONCENTRATE FOR HEMODIALYSIS Cc 31_| DIALYZER 7 aa) 32 DIAMOND DISC A 33_|_ DISINFECTANT OF MEDICAL DEVICES ic 34_| DRAINAGE POUCHE (ALLTYPES) A 35 DRESSING | cua A b. Dressing w/ absorbable component B | ¢. Dressing with medicine i D Es |. Dressing with biologic 2 D 36 | DRILL BIT, BONE/SURGICAL ATS 37 DRUG DELIVERY EMBOLIZATION SYSTEM D 38 DRY POWDER INHALER (WITHOUT MEDICINE) A 39_| EAR WAX REMOVER (NON-ACTIVE) = A 40_| ELECTRODE NEEDLE/PENCIL (ELECTROSURGICAT) B 41_|_EMBOLIC PROTECTIVE DEVICE/SYSTEM a D 42 | ENDOSCOPIC HARVESTING INSTRUMENT _ az) a. Re-usable A b. Single Use B 43_| EPIDURAL PROBE B 44_| EVACUATOR A 45_| EYE LIGHT SHIELD z A | 46” |_FEEDING SET ee) | a, Feeding Set thru body orifice B b. Feeding Set surgically invasive iG 47 |_FILLER a. Absorbable (All types) D b. Non-Absorbable 4 iG48] FLOWMETER (All types) A 49 GASTRIC BAND Cc 50 GAUZE cae FRearaPSESE| a. Gauze A . Gauze, internal sponge [faaBi ¢. Gauze with medicine D d. Gauze with biologic D SL GINGIVA FORMER = = B 52_| GUIDEWIRE, GUIDE CATHETER B 33_| HEART VALVE D 34_| IMPLANTABLE DEFIBRILLATOR D 55 IMPLANTABLE HEARING DEVICE i= c 56_| IMPLANTABLE LEAD [aeaD) = IMPLANTABLE PACEMAKERS D 58__| IMPRESSION MATERIAL ae '59_|_ INFLATION DEVICE a A 60_| INTRAOCULAR LENS [cau 61_| INTRAUTERINE CONTRACEPTIVE DEVICE (UD) D 62_| INTRODUCER Z B 63 | KNOT PUSHER 7 ima | a. Reusable ne { b. Single use H B 64_| LANCET - B 65_| LARYNGEAL MASK [eam 66_| LUER LOCK A 67 LUMBAR PUNCTURE TRAY/KIT ¢ 68 MOISTURE/LUBRICATING EYEDROP. B 69 NASAL SPRAY (WITHOUT CLAIMS) A 70_| NASOPHARYNGEAL AIRWAY A 71_|_NEUROVASCULAR REMODELLING DEVICE D 72_|_NON-STEROIDAL CREAM/ SKIN BARRIER (TOPICAL) B a OPHTHALMIC DROP/SOLUTION _ B 74_| PEN INJECTOR 5 FAeR) 75__| PLASTER OF PARIS A 76_| RENAL DILATATION SET B 77 REVASCULARIZATION DEVICE D 78 |_RETRACTOR a Reusable A __|_b. Single-use_ boast a B 79 | SCALP VEIN INFUSION SET an zt B SOMIESHARANT: ‘i i =z a, Wound Sealant B . From animal source D 81 [SHUNT SYSTEM a. All types, except for CNST and CCS* G ’. For CNS! and CCS? (Ea 82_| SKIN BARRIER FOR OSTOMY USE Pa A 83 | SKIN TRACTION SYSTEM A 85 86 Implantable with Direct contact aap | . Implantable iG L ¢. Extemal or Non-implantable A 87 _|_STENT 7 “a. Short® term use except those touching CNST and C B b. Long term’ use except those touching CNS" and CCS? ic ¢. Short’ or Long Term* use touching CNS! and CCS” D A A 88__| STOMA ADHESIVE PROTECTIVE POWDER/WAFER. 89_| STOP COCK ianiaai 90 | SURGICAL BLADES (ALL TYPES) in A AR | B. Single Use_ ia I B 91 |_SURGICAL DRAPE, STERILE rate [sane] . Drape = A |__|». Drape with Self Retaining Finger Cot das; 92_| SURGICAL KNIFE, STERILE B 93 | SUTURE (WITH OR WITHOUT NEEDLE) _ ze a. Suture, Nonabsorbable, Synthet 1 In contact with CNS", CCS* a In contact with deep tissue Be. mer Absorbable (from animal souree) c. Sul Suture, Dental e, Sutu C £, Suture, Steel ie 94 | SUTURE ANCHOR Ey a. Non-absorbable “b. Absorbable 95_ | SYNTHETIC CAST PADDING |ala|a}o >|ola 96 |_SYRINGE erie az a, Syringe with Needle lo] >|>| a0 | TISSUE EXPANDER sl a. For breast implant D b. Other parts of the body tae c 700 | TRACHEOSTOMY KIT B 101 | TROCARSYSTEM 5 mz a. Single use B | |b. Reusable A 102_| UMBILICAL CLAMP oe} 103 ‘VASCULAR ACCESS SYSTEM D104 | VENTICULAR PROBE ] 105_| WOUND DRAINAGE KIT | 106 | ALL OTHER IMPLANTABLE MEDICAL DEVICES (IN PARTS OR IN SYSTEM) a. Active Implants b. Heart Implants ¢. Brain Implants Breast Implants e. Spinal Implants £ Dental Implants including Abutment g. Orthopaedic Implants h. All other implants 2] 5] ala}a|s|o}y|s]9| Footnote: CNS! Central Nervous System - refers tothe brain, meninges and spinal cord CCS" Central Citculatory System -means the major intemal blood vessels including the following: | + arteriae pulmonales (pulmonary artery); | + aoma ascendens (ascending aorta): + arteriae coronariae (coronary artery): + artera carotis communis (common carotid artery); + artera earotis externa (extemal carotid artery); + atera caotis interna (internal carotid artery); + arteriae cerebrates (cerebella arteries); + rancus brachiocephalicus (brachiocephalic trunk): + ven cords (cardiac veins); + venae pulmonales (pulmonary vein); + venae cava superior (superior vena cava); + venae cava inferior (inferior vena cava); + arcus aorta (aortic arch); + thoracica aorta (thoracic aorta}; + ahdominalis aorta (abdominal aorta); + arteraeilca communis (common iliac arteries): + aorta descendens tothe bifurcatio aortae (descending aorta tothe bifurcation of aorta) ‘Short term use! Normally intended for continuous use for between 60 minutes and 30 days Long term use* Normally intended for continuous use for more than 30 days Transient use* Normally intended for continuous use for less than 60 minutes This Circular shall take effect fifteen (15) days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the Office of the National Administrative Register. w ROLANDO ENRIQUE P. DOMINGO, MD. Director General DIN: 2200717132153, 10