Republic of the Philippines FOOD AND DRUG ADMINISTRATION FDA CIRCULAR No. 209,0-00}-A TO: SUBJECT Department of Health (04 JAN 202, 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 __- : = Sea NAME OF MEDICAL \cLASS NAME OF MEDICAL CLASS es ___ DEVICE a DEVICE 1 ABSORBABLE ABSORBABLE HEMOSTATIC HEMOSTATIC AGEN AGENTS aa sacar enle venwetate a, Absorbable Hemostatic Agents, e 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, CD | “Collagen Based Be A] ADHESIVE A al 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 ase SET (ALL | SYSTEM ye DELIVERY S' TEM | a. With needle B__|a. With needle _ b. Without needle HH b. 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 b.2. Blood/Body Liquids! 2. Blood/Body Liquids B Gases a crepes ener Peer ) 4 | BANDAGE a a. All types A_| BANDAGE A ___ |. 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 | | ees 28 |i. |. ota 6 | BURR, DENTAL AIB | BURR, DENTAL) SURGICAL/ORTHOPEDIC |_SURGICAL/ORTHOPEDIC a. Reusable ilies ». Single use7] CANNULA (ALL CANNULA (ALL TYPES) TYPES) ess: _ a, Reusable aReusable ». In contact with the b. In contact with the CNS" CNS! and CCS? Cost | ©. Through body orifice ¢. Through body orifice D ¢.2 Short’ term ic ‘d. Short term’ use, Single avt| (a Short? term us Single use, 5 use, Disposable use Disposable use a 8 | CATHETER (ALL ee CATHETER (ALL TYPES) Hi a B__| a. Short’ term use TE C_| b. Long’ term use c ¢. Through body orifice | A,B, |_c. Through body orifice c ¢.1 Transient’ use 4 In contact with the |__CNS'! and CCS? ae 9 | CEMENT CEMENT, DENTAL/BON DENTAL/BONE a. Cement, Dental | B_| a Cement, Dental |b. Cement, Bone Synthetic | C/D |b. Cement, Bone Synthetic | c. Cement, Bone Natural_| D_| c. Cement, Bone Natural 10 cu P CLIP a. Invasive except those touching CNS! and CCS? a. Invasive b. Invasive, touching CNS" and ccs? [ zt €. Non-invasive 11 | CLOSURE DEVICE; CLOSURE DEVICE; SKIN SKIN STAPLER STAPLER (INCLUDING | (INCLUDING REMOVER) REMOVER) _ a. Non invasve_ b. Invasive a. Non invasive wasive except those touching a. Endovascular Coil CID | a. Vascular Coil . Neurovascular Coil p | >. Endovascular | Coil/Neurovascular Coil CONICALICORNEAL | B/C | CONICAL/CORNEAL RING RING SEGMENT SEGMENT | | a. Short’ term use |__| b. Long® term use es[ 14] CYTOLOGY BRUSH CYTOLOGY BRUSH (Biopsy. Peseta conceal ee neral & Plastic Surgery) Plastic Surgery) s “a. Body orifice ‘a. Body orific A [[b. Surgically Invasive b. Surgically hi B [7s lll DENTAL RESTORATIVE ; MATERIAL | a. Transient® use, not absorbed by A | i | mucus membrar =e | babehine Vem By, short term or long* term use B | Suspension eerie 16 | DISSECTOR [NEEM] DISSECTOR rencna A. Reusable “A_| A.Reusable A B. Single Use B_|B. Single Use eal 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 7a patient) b. Intended to filter liquids and a gases 18 | GLOVES : GLOVES Saicast| A —— Non-sterile | 4 | a, Examining, Non-sterile gloves. | A gloves Bel ___|b. Surgical, Sterile Gloves | B_ | b. Surgical, Sterile Gloves B 19 GRAFT a. Absorbable D c 20 | IMPLANTABLE C/D IMPLANTABLE PROSTHESIS II PROSTHESIS a. Not in direct contact with the a heat BCS? | b, In direct contact with the heart, |) CNS! and CCS? " 21 | LUBRICATING LUBRICANT/TRANSMISSION GELJELLY GELJELLY a. External A__| a. External a, . Internal ‘A_| b. Internal B 22 | MASK (silicone B | MASK A 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 7NEEDLE (All types, except for tattoo and acupuncture) NEEDLE (ALL TYPES, EXCEPT FOR TATTOO AND ACUPUNCTURE) a. Except those touching CNS" and ccs? b. Touching CNS" and CCS* 24 | OPHTHALMIC B/D | OPHTHALMIC VISCOELASTIC VISCOELASTIC DEVICE 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, | tissues and/or derivates of i microbial or recombinant origin 25 | ORTHOPAEDIC WIRE | B/C | ORTHOPAEDIC WIRE Short term us |__| b. Long® term use 26 | PERCUTAENOUS B PERCUTAENOUS RETRIEVAL RETRIEVAL DEVICE | DEVICE | ‘a. Except those touching CNS! and ce: Pi |_b. Touching CNS! and CCS? 27 ‘| PLASTER/PLASTIC PLASTER/PLASTIC STRIP | STRIP (ALL TYPES) | (ALL TYPES) | a. Gauze a, Plaster [b. Gauze, intemal sponge b. Plaster with medicine eae guae a medicine 7] & Plaster with biologic | 28 | RECONSTRUCTION | B/C | RECONSTRUCTION KIT/DEVICE; | KIT/DEVICE; FIXATION DEVICE | DEVICE | | a. Reusable | | b. Short’ term use | Be ¢. Long’ term use ie 29. | SILICON OIL IN VIAL SILICON OIL (INTRAOCULAR FOR OPHTHALMIC USE FLUID)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 ‘NB | 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 € ‘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 =a A 2 ACCESS/INJECTION PORTS a c 3__|_ ACETABULAR i a = 4 ADAPTOR/CONNECTOR (ALL TYPES) A [3 __| ANCHOR, PREFORMED A 6 | ANESTHESIA SET i 7__|_ANNULOPLASTY RING D 8 APHERESIS KIT/ CELL SEPARAT ION KIT B z= ARTIFICIAL SALIVA. A 10_| BASE PASTE A 11_|_ BIOPSY NEEDLE/INSTRUMENT (ALL TYPES) B BLOODBAG SOR 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 [sae 21_| CHEST DRAINAGE KIT Bal) a, Active type (aa lee b. Analog type (Except mercurial type) = A 23° |_CLIP APPLIER Bx, a a. Reusable 2 A b. Single use z B 24_| COLLAGEN i D 25 |_CONDOM 7 frestasizetall | |_a. Condom (All types) 2 Cc |b. Condom with spermicide TED __|e. Condom - Natural Membrane i 26_| CONTACT LENS SOLUTION he Ge | 27_[ CONTACT LENS, INCLUDING COSMETIC CONTACT _ iz LENSES | 28_| CORSET CAST Aaa 29 | COTTON (medical/hospital use) i a. Cotton: : A b. Paddie, Cottonoid i B 30_|_ DIALYSATE CONCENTRATE FOR HEMODIALYSIS iS 31_| DIALYZER 7a 32 DIAMOND DISC A 33_|_ DISINFECTANT OF MEDICAL DEVICES ic 34__| DRAINAGE POUCHE (ALL TYPES) A 35 DRESSING as oa A b. Dressing w/ absorbable component B | ¢. Dressing with medicine a D Ps |. Dressing with biologic 2 D 36 | DRILL BIT, BONE/SURGICAL A_| 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 5 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 : A | 46” |_FEEDING SET Or | a, Feeding Set thru body orifice B b. Feeding Set surgically invasive iG 47 |_FILLER a. Absorbable (All types) D b. Non-Absorbable _ iG48__| FLOWMETER (All types) A 49 GASTRIC BAND Cc 50 GAUZE pad. FLearaPSESE| a. Gauze A . Gauze, internal sponge [aan ¢. Gauze with medicine Dd d. Gauze with biologic D SL GINGIVA FORMER = mt B 52_| GUIDEWIRE, GUIDE CATHETER B 33_| HEART VALVE D 34_| IMPLANTABLE DEFIBRILLATOR D 55 IMPLANTABLE HEARING DEVICE ut c 56_| IMPLANTABLE LEAD ie) 5S7 IMPLANTABLE PACEMAKERS D 58_| IMPRESSION MATERIAL ae '59_|_INFLATION DEVICE ee: A 60_| INTRAOCULAR LENS (ETE: 61_|_INTRAUTERINE CONTRACEPTIVE DEVICE (UD) D 62_| INTRODUCER re B 63 | KNOT PUSHER 7 ima | a. Reusable ae | b. Single use a B 64_| LANCET zi B 65_| LARYNGEAL MASK LE 66 | LUER LOCK A 67 LUMBAR PUNCTURE TRAY/KIT c 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 73 OPHTHALMIC DROP/SOLUTION bi B 74_| PEN INJECTOR i ras 75__| PLASTER OF PARIS A 76_| RENAL DILATATION SET B 77 REVASCULARIZATION DEVICE D 78 |_RETRACTOR [eee Reusable A ___|_b. Single-use_ ae iE B 79_| SCALP VEIN INFUSION SET af a B SOMMNSHANANT: 0 ‘i : az a, Wound Sealant B ', From animal source D 81_[_ SHUNT SYSTEM a. All types, except for CNST and CCS* c ’. For CNS! and CCS? [eam 82_|_ SKIN BARRIER FOR OSTOMY USE ais A 83__| SKIN TRACTION SYSTEM A 835 86 Implantable with Direct contact aD | b. Implantable G L ¢. External 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? c ¢. Short’ or Long Term* use touching CNS! and CCS” D A A 88 _| STOMA ADHESIVE PROTECTIVE POWDER/WAFER. 89_| STOP COCK aa 90 | SURGICAL BLADES (ALL TYPES) ia A AR | B. Single Use_ Sei I B 91 |_SURGICAL DRAPE, STERILE iam abil . Drape = A |__|». Drape with Self Retaining Finger Cot ‘ae 92_| SURGICAL KNIFE, STERILE B 93 | SUTURE (WITH OR WITHOUT NEEDLE) _ fiesenteaas) a, Suture, Nonabsorbable, Synthet 1 In contact with CNS", CCS* att In contact with deep tissue ne: Suture Absorbable (from animal souree) c. Sul Suture, Dental e, Sutu C £, Suture, Steel aa 94 |_SUTURE ANCHOR poses a. Non-absorbable “b. Absorbable 95_ | SYNTHETIC CAST PADDING jala}alo >|ola 96 |_SYRINGE ys tle az a, Syringe with Needle lo] >|>|o0 | TISSUE EXPANDER al a. For breast implant D b. Other parts of the body wae @ 100 | TRACHEOSTOMY KIT B 101 | TROCARSYSTEM 5 ma a. Single use B | |b. Reusable A 102_[ UMBILICAL CLAMP Amel 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] S| ala}a|s|o}y|s]9} Footnote: CNS! Central Nervous System - refers tothe brain, meninges and spinal cord CCS? Central Cinculatory 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); + artera carotis interna (internal carotid artery); + arterie 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); + areus aorta (aortic arch); + thoracica aorta (thoracic aorta}; + abdominalis 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 69 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 DTN: 2020717132153, 10