It consists of the following four fields: Keyword, Preferred Name Code (PNC), Class and Description. Medical Devices Bureau – Outline • Stakeholders • Regulatory Framework History Provisions/ prohibitions Classification Application Requirements • Other access routes 2 . After the release of the initial Catalog in 2002, CFDA has made several modifications to standardize the classification and streamline the registration process. The rules that apply to your medical device depend on how your product is classified by the regulatory agencies. PORT AND CATHETER, INFUSION, IMPLANTED, SUBCUTANEOUS, CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING, CATHETER, INTRACARDIAC MAPPING, HIGH DENSITY ARRAY, CATHETER, OCCLUDING, CARDIOVASCULAR, IMPLANTABLE, CATHETER, TRANSLUMINAL, CORONARY ANGIOPLASTY, PERCUTANEOUS, SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS, TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER, CHAIR, DIALYSIS, UNPOWERED, WITHOUT SCALES, CHAIR, PNEUMOENCEPHALOGRAPHIC, RADIOGRAPHIC, CHAIR, POSTURE, FOR CARDIAC AND PULMONARY TREATMENT, CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY, HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP), ACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES, COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES), COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES), COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES), PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION, IMPLANT, RESORBABLE BOVINE COLLAGEN, MENISCAL REPAIR, KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER, COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER, TOTALLY IMPLANTED SPINAL CORD STIMULATOR FOR PAIN RELIEF, COMPRESSION UNIT, INTERMITTENT (ANTI-EMBOLISM PUMP), COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION, CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE), GENERATOR, RADIOGRAPHIC, CAPACITOR DISCHARGE, SEALANT, PIT AND FISSURE, AND CONDITIONER, RESIN, SOLUTION-TEST STANDARD CONDUCTIVITY, DIALYSIS, CONSOLE, HEART LUNG MACHINE, CARDIOPULMONARY BYPASS, INSTRUMENT, CONTOURING, MATRIX, OPERATIVE, CONTRACEPTIVE, VAGINAL (FOAM, GEL, SUPPOSITORY), DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES), INTRAUTERINE, DEVICE, CONTRACEPTIVE (IUD) AND INTRODUCER, CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS, CONTROLLER, HEMODIALYSIS UNIT, SINGLE NEEDLE, CONTROLLER, INTRAVASCULAR, INFUSION, ELECTRONIC, CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS, DEVICE, INFLATION CONTROL FOR DILATION BALLOONS, SUCTION CONTROL, INTRACARDIAC, CARDIOPULMONARY BYPASS, CONVERTER, HEMODIALYSIS UNIT, SINGLE PASS, INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT, PROBE AND COUNTER, ISOTOPE, FOR PHOSPHORUS 32, SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE, VENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS), DEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY, LASER, NEODYMIUM:YAG, OPHTHALMIC FOR POSTERIOR CAPSULOTOMY, CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE, SUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER, RHINOANEMOMETER (MEASUREMENT OF NASAL DECONGESTION), DC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES), DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, LEAD, ELECTRODE, CARDIOVERTER, DEFIBRILLATOR, PERMANENT, DENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE), RESIN, DENTURE, RELINING, REPAIRING, REBASING, TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT, LIGHT, THERAPY, SEASONAL AFFECTIVE DISORDER (SAD), IMPLANT, DERMAL, OTHER, FOR AESTHETIC USE, DERMAL IMPLANTS OF COLLAGEN FOR AESTHETIC USE, DETECTOR, BLOOD FLOW, ULTRASONIC (DOPPLER), DETECTOR, FETAL HEART, ULTRASONIC (DOPPLER), SEMI-AUTOMATIC PERITONEAL DIALYSATE DELIVERY SYSTEM, SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT, SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT, SYSTEM, DIALYSATE DELIVERY, SORBENT REGENERATED, SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE, SET, DIALYSIS, SINGLE NEEDLE WITH UNI-DIRECTIONAL PUMP, SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE, STATION, DIALYSIS CONTROL, NEGATIVE PRESSURE TYPE, DIALYZER, COMPOSITE, HEMODIALYSIS/HEMOPERFUSION, DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE, DIATHERMY, MICROWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT, DIATHERMY, MICROWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT, DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT, DIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT, DIATHERMY ULTRASONIC, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT, DISLODGER, STONE, BASKET, URETERAL, METAL, DEVICE, MEDICATION RECONSITITUTION/TRANSER DEVICE, DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY, EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR, SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, DRAPE, PURE LATEX SHEET, WITH SELF RETAINING FINGER COT, MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID, DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE, STIMULATOR, SPINAL CORD, IMPLANTED, FOR BLADDER EVACUATION, PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT, ASSEMBLY, SHOULDER/ELBOW/FOREARM/WRIST/HAND, MECHANICAL, JOINT, ELBOW, EXTERNAL LIMB COMPONENT, MECHANICAL, PROSTHESIS, ELBOW, NON-CONSTRAINED, UNIPOLAR, RECORDER, LONG TERM, ECG, PORTABLE (HOLTER MONITOR), SYNCHRONIZER,ECG/RESPIRATOR, RADIOGRAPHIC, ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES), ELECTRODE, BIOPOTENTIAL, SURFACE, METALLIC, ELECTRODE, CLIP, FETAL SCALP (AND APPLICATOR), ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL, ELECTRODE, METALLIC WITH SOFT PAD COVERING, ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH, ELECTRODE, DEFIBRILLATOR (INTERNAL, NON-IMPLANTED), UNIT, ELECTROLYSIS, AC-POWERED, OPHTHALMIC, EQUIPMENT, ELECTROSURGICAL, SPECIAL PURPOSE, ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY, ENDOSCOPE, FETAL BLOOD SAMPLING (AND ACCESSORIES), EXCHANGE DEVICE, PERCUTANEOUS TRANSLUMINAL CATHETER, FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE, FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS, EXERCISER, NUCLEAR DIAGNOSTIC (CARDIAC STRESS TABLE), FASTENER, FIXATION, BIODEGRADABLE, HARD TISSUE, FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE, FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE, PROSTHESIS, FEMOROTIBIAL, CONSTRAINED (METAL-ON-POLYMER), FILE, SURGICAL, GENERAL & PLASTIC SURGERY, FILLER, CALCIUM SULPHATE PREFORMED PELLETS, FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY, FILTER, PREBYPASS, CARDIOPULMONARY BYPASS, PROSTHESIS, FINGER, CONSTRAINED, METAL, CEMENTED, DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT, DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE, FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE, FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED, FLOWMETER, BLOOD, NON-INVASIVE ELECTROMAGNETIC OR DOPPLER, RADIOGRAPHIC/FLUOROSCOPIC UNIT, MOBILE C-ARM, ABSORBABLE HEMOSTATIC AGENTS NON-COLLAGEN BASED, FORCEPS, BIOPSY, BRONCHOSCOPE (RIGID) (DISPOSABLE), INSTRUMENT, CRANIOPLASTY MATERIAL FORMING, GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS, GAUZE, NONABSORBABLE, MEDICATED (INTERNAL SPONGE), GAUZE, NONABSORBABLE, NON-MEDICATED, (INTERNAL SPONGE), GAUZE, NONABSORBABLE, X-RAY DETECTABLE (INTERNAL SPONGE), JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT, GENERATOR, ELECTROSURGICAL, COAGULATION, CANCER, GENERATOR, HIGH VOLTAGE X-RAY THERAPEUTIC, GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC, GENERATOR, LOW VOLTAGE, THERAPEUTIC X-RAY, GENERATOR, ORTHOVOLTAGE, THERAPEUTIC X-RAY, GENERATOR, PULSALITE FLOW, CARDIOPULMONARY BYPASS, MATERIALS, REPAIR OR REPLACEMENT, PACEMAKER, PULSE-GENERATOR, PACEMAKER, EXTERNAL, PROGRAMMABLE, GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY, PROSTHESIS, ARTERIAL GRAFT, BOVINE CAROTID ARTERY, PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER, PROSTHESIS, VASCULAR GRAFT, OF LESS THAN 6MM DIAMETER, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT, HAND, EXTERNAL LIMB COMPONENT, MECHANICAL, ACCESSORIES, PHACOFRAGMENTATION/EMULSIFICATION UNIT, HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL, HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL, TERMINAL HEADER OR PLUG FOR PULSE GENERATOR, HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER), SINGLE NEEDLE DIALYSIS SET (CO-AXIAL FLOW), TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS, ABSORBABLE HEMOSTATIC AGENTS, COLLAGEN BASED, PROSTHESIS, HIP, ACETABULAR COMPONENT, METAL, NON-CEMENTED, PROSTHESIS, HIP, ACETABULAR COMPONENT, POLYETHYLENE, PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/ POLYMER, PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL, PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL, PROSTHESIS, HIP, HEMI-, FEMORAL, METAL, NON-CEMENTED, PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED, PROSTHESIS, HIP, METAL STEM/CERAMIC SELF-LOCKING BALL, PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT), PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/CERAMIC/POLYMER, PROSTHESIS, HIP, SEMI-CONSTRAINED OR HEMI-, METAL/PTFE, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED, PROSTHESIS, HIP, SEMI-CONSTRAINED, POROUS COATED, PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, POROUS, METAL/POLYMER, DEVICE, INTRAVASCULAR CATHETER, SECUREMENT, HOOK, EXTERNAL LIMB COMPONENT, MECHANICAL, HOOK, SURGICAL, GENERAL & PLASTIC SURGERY, HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE), SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA), NEEDLE, ASPIRATION AND INJECTION, REUSABLE, DEVICE, HYPOTHERMIA THERAPY - INHALATION REWARMING, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE CAMERA, SYSTEM, IMAGING, DENTAL, DIGITIAL - FILMLESS, SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING, SYSTEM IMAGING, PULSED DOPPLER, ULTRASONIC, STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS, IMPLANT, ABSORBABLE (SCLERAL BUCKLING METHOD), IMPLANTED SUBCUTANEOUS PERITONEAL ACCESS DEVICE, POLYMER, ENT COMPOSITE SYNTHETIC PTFE WITH CARBON-FIBRE ENT, POLYMER, ENT SYNTHETIC-PIFE, SILICONE ELASTOMER, POLYETHYLENE, POLYURETHANE, POLYMER, ENT, SYNTHETIC, POROUS POLYETHYLENE, PROSTHESIS IMPLANTATION INSTRUMENT, FALLOPIAN TUBE, PROSTHESIS IMPLANTATION INSTRUMENT, ORTHOPEDIC, DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC, INFUSION SYSTEM, IMPLANTABLE, DRUG ADMINISTRATION, INHIBITOR, POSTOPERATIVE FIBROSIS, TENOLYSIS, INJECTOR & ACCESSORIES, UTERINE MANIPULATOR, EQUIPMENT, IN-VITRO FERTILIZATION/EMBRYO TRANSFER, INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC, KIT, INSTRUMENTS AND ACCESSORIES, SURGICAL, SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES), INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT, INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT, INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE, INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES), EQUIPMENT, SUCTION/IRRIGATION, ENDOSCOPIC, SOURCE, ISOTOPE, SEALED, GOLD, TITANIUM, PLATINUM, PROSTHESIS, KNEE PATELLOFEMOROTIBIAL CONSTRAINED, CEMENTED, POLYMER/METAL, PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL, PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER, PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, PROSTHESIS, KNEE, HEMI-, PATELLAR RESURFACING, UNCEMENTED, PROSTHESIS, KNEE, HEMI-, TIBIAL RESURFACING, UNCEMENTED, PROSTHESIS, KNEE, PATELLOFEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER, PROSTHESIS, KNEE, UNICOMPARTMENTAL, CEMENTED, LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES), SHEATH, CORRUGATED RUBBER, FOR NONINDWELLING CATHETER, LEAD, PACEMAKER, IMPLANTABLE, INDIFFERENT, LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION), LENS, CONTACT, POLYMETHYLMETHACRYLATE, DIAGNOSTIC, LENSES, SOFT CONTACT, EXTENDED WEAR (LESS THAN 30 DAYS), MEMBRANE, LUNG (FOR LONG-TERM RESPIRATORY SUPPORT), MALLET, SURGICAL, GENERAL & PLASTIC SURGERY, SPHYGMOMANOMETER, ELECTRONIC (ARTERIAL PRESSURE), MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE, DISTANCE MEASUREMENT, PUPILLARY/NASAL-PUPILLARY, DEVICE, MEASURING, LENS RADIUS, OPHTHALMIC, METER, AIRWAY PRESSURE (INSPIRATORY FORCE), MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC, MICROSCOPE, OPERATING, NON-ELECTRIC, OPHTHALMIC, MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY, SYSTEM, THERMOTHERAPY, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA), MIXER, BREATHING GASES, ANESTHESIA INHALATION, SYSTEM, PATIENT MONITORING - MULTI-FUNCTION COMPONENTS, MONITOR, BLOOD PRESSURE, TRANSDUCER, NON-INDWELLING, MONITOR, TEMPERATURE, GENERAL & PLASTIC SURGERY, BLOOD PRESSURE/OXYGEN SATURATION IN THE BLOOD MONITOR, MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY, MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM), MONITOR, BLOOD GAS, ON-LINE, CARDIOPULMONARY BYPASS, MONITOR, BLOOD GAS, TRANSCUTANEOUS OXYGEN, MONITOR, BLOOD PRESSURE, TRANSDUCER, INDWELLING, MONITOR, BLOOD-PRESSURE, NEONATAL, ULTRASONIC/DOPPLER, MONITOR, CARDIAC OUTPUT, THERMAL (BALLOON TYPE CATHETER), MONITOR, CARDIAC OUTPUT, TREND (ARTERIAL PRESSURE PULSE, MONITOR, ELECTROENCEPHALOGRAPHIC, FETAL (AND ACCESSORIES), MONITOR, ELECTROENCEPHALOGRAPHIC, GENERAL & PLASTIC SURGERY, MONITOR, PRESSURE, HEMODIALYSIS, EXTRACORPOREAL, MONITOR, CEREBRAL BLOOD FLOW, THERMAL DIFFUSION, DEVICE, MONITORING, BALLOON/CUFF PRESSURE, SYSTEM, PATIENT MONITORING - CENTRAL STATION, MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED, OCULO-MOTOR MOVEMENT TRAINING, OPHTHALMIC, PROSTHESIS, RHINOPLASTY/NASAL DORSAL IMPLANT, DEVICE, INTRAVASCULAR CATHETER SECUREMENT, NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER), NEEDLE, ISOTOPE, GOLD, TITANIUM, PLATINUM, REPLACEMENT, OCCICULAR, POROUS POLYETHYLENE, PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE), PACEMAKER, HEART, IMPLANTABLE, ANTI-TACHYCARDIA, PACEMAKER, HEART, IMPLANTABLE, DUAL CHAMBER, PACEMAKER, HEART, IMPLANTABLE, NON-PROGRAMMABLE, PACEMAKER, HEART, IMPLANTABLE, RATE RESPONSIVE, TEMPORARY PACING SYSTEM, ACUTE, INTERNAL, ATRIAL, PADDLE, PAD, ELECTRODE, DEFIBRILLATOR (EXTERNAL), INSTRUMENT, LIGATURE PASSING AND KNOT TYING, SYSTEM, PHACOEMULSIFICATION & ACCESSORIES, PHANTOM, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES), PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS, SYSTEM, PLANNING, RADIATION THERAPY TREATMENT, PLETHYSMOGRAPH, PHOTOELECTRIC, PNEUMATIC OR HYDRAULIC, POLISHER, EXTRACAPSULAR EXTRACTION PROCEDURE, POLYMER, ENT COMPOSITE SYNTHETIC PTFE WITH CARBON-FIBRE. From Health Canada. 25+ years market expertise. Health Canada is the federal regulator of therapeutic products, including medical devices. Like all health products, medical devices have benefits and risks. Repeal. Medical devices in Japan are classified based on risk to the human body. In vitro diagnostic medical device (IVD) defined: Yes Text: Defined separately. 63 Sections 64 and 65 do not apply to (a) a retailer; or (b) a health care facility in respect of a medical device that is distributed for use within that facility. Class I (lowest risk), Class II, Class III, and Class IV (highest risk). 3.6 Medical devices: National lists 3.6.1 Introduction Health care delivery is a complex endeavor that encompasses numerous specialized fields and entails a multitude of decisions based on the medical care needed on national and local levels. Obtaining an MDL is comparable to the US FDA 510 (k) process. Class II devices are not exempt from GMP requirements. CARDIOTACHOMETER & RATE ALARM), IMPLANT, CARTILAGE, FOR ARTICULAR CARTILAGE REPAIR, BALLOON CATHETER FOR RETINAL REATTACHMENT, CATHETER (GASTRIC, COLONIC, ETC. Determine the classification of your medical device according to Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282 as published by Health Canada. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada. As per section 6 of the Regulations, medical devices are classified into one of four classes where Class I represents the lowest risk and Class IV the highest. 5… All med… Intent of the medical device establishment licensing requirements in the Medical Devices Regulations 1. 2.3 How to Use the Medical Device Keyword Index. ), ACCESSORIES, TRACTION (CART, FRAME, CORD, WEIGHT), UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING, TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR, ENGINE, TREPHINE, ACCESSORIES, AC-POWERED, TREPHINE, MANUAL, OPHTHALMIC (DISPOSABLE), TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION, TUBE, SINGLE LUMEN, W MERCURY WT BALLOON FOR INTES. The new … ), ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC. Devices fall into Class I, Class II, Class III or Class IV. Recall. Class I devices present the lowest potential risk (e.g. 96 [Repeal]. thermomete… Classification of Medical Devices. A year later, it became effective on August 1, 2018. Drugs and health products - Canada.ca. ), ANALYZER, GAS, MULTIPLE, GASEOUS PHASE (ANESTHETIC CONC. Medical Device Regulations, 6. Federal laws of canada. (a)the sale and advertising for sale of a medical device; and 2. STIMULATOR, OSTEOGENESIS, ELECTRIC, BATTERY-OPERATED, STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF), IMPLANTED AUTONOMIC NERVE STIMULATOR FOR EPILEPSY, STIMULATOR, DIAPHRAGMATIC/PHRENIC NERVE, IMPLANTED, STIMULATOR, INTRACEREBRAL/SUBCORTICAL, IMPLANTED, STIMULATOR, SPINAL CORD, IMPLANTED (PAIN RELIEF), STIMULATOR, VEGUS NERVE, IMPLANTED, EPILEPSY, STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL, STYLET, SURGICAL, GENERAL & PLASTIC SURGERY, SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS, APPARATUS, SUCTION, OPERATING ROOM, WALL VACUUM POWERED, APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED, APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED, APPARATUS, SUTURING, STOMACH AND INTESTINAL, SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID, SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE, SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE, SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE, SUTURE, SURGICAL, NONABSORBABLE, POLYBUTESTER, SYNCHRONIZER, ECG/RESPIRATOR, RADIOGRAPHIC, SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING, SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL, TABLE, OBSTETRICAL, AC POWERED (AND ACCESSORIES), TABLE, OBSTETRICAL, MANUAL (AND ACCESSORIES), TABLE, RADIOGRAPHIC, NON-TILTING, POWERED, TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED, TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL, TAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE, TELEMETRY UNIT, PHYSIOLOGICAL, MULTIPLE CHANNEL, TELEMETRY UNIT, PHYSIOLOGICAL, TEMPERATURE, TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH, SYSTEM, ISOKINETIC TESTING AND EVALUATION, TIP, SUCTION TUBE (YANKAUER, POOLE, ETC. The Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is intended to assist manufacturers in confirming the classification of medical device products after application of the Classification Rules for Medical Devices set out in Schedule 1 of the Medical Devices Regulations. Please note that this document is provided only as a guide and that in the event of any discrepancy between this document and the Classification Rules for Medical Devices described in the Medical Devices Regulations, the latter shall prevail. Device Identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. Health Canada Medical Device Establishment Licence (MDEL) – Inspections, Audits and Compliance June 2009. The Medical Device Keyword Index is an alphabetical listing of words which appear in the short descriptors for medical device groups identified by the Medical Devices Bureau. &/OR DECOMPRESSION, TUBE, TRACHEAL (ENDOTRACHEAL) (W/WO CONNECTOR), TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION, ASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC, ASSEMBLY, TUBE HOUSING, X-RAY, THERAPEUTIC, KIT, TUBING HEMODIALYSIS, HEMOPERFUSION, HEMOFILTRATION, SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS), TUBING, INSTRUMENTATION, BRONCHOSCOPE (BRUSH SHEATH A/O ASPIRATING), TUBING, REPLACEMENT, PHACOFRAGMENTATION UNIT, INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC, VALVE, POSITIVE END EXPIRATORY PRESSURE (PEEP), VALVE, PRESSURE RELIEF, CARDIOPULMONARY BYPASS, ATTACHMENT, INTERMITENT MANDATORY VENTILATION (IMV), VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING, VENTILATOR, PRESSURE CYCLED (IPPB MACHINE), WEIGHTS FOR STABILIZING MATERIAL DURING PROCEDURE, UNIT, WRIST, EXTERNAL LIMB COMPONENT, MECHANICAL, ASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSITC. MDALL online query is an HTML application used to search the MDALL. The majority of tracheostomy tubes (PNC 73EQK) are Class II medical devices by Rule 2(1) of the Medical Devices Regulations. Health Canada is pleased to announce the release of the revised Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices. Class I, II, III, IV Health Canada MDEL applications. (2) Section 32, except paragraphs (2)(f), (3)(j) and (4)(p), comes into force (a) in the case of a medical device referred to in section 94 or 95, on September 1, 1998; (b) in the case of any other medical device, on July 1, 1998. Only products which appear in this database listing may be offered for general marketing purposes in Canada. 97 (1) Subject to subsections (2) to (5), these Regulations come into force on July 1, 1998. This Device Advice: e-Learning tool is intended to educate stakeholders on the premarket regulatory requirements for medical devices in Canada. Dear visitor, We have reorganized our Web site. INTUB. The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. The classifications are, for the most part or as a general rule, related to the perceived risk of the product type. For instance, to verify the risk-based classification of dental burs, enter "bur" or "drill" in the "Find" field. The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. A search can be done by Company Name, Company ID, Licence Name, Licence Number, Device Name, Device Identifier. MATERIALS, FABRICATING PROSTHODONTIC APPLIANCES, DENTAL LAB. Guaranteed Performance. We manage the entire application process for Health Canada Medical Device Establishment License (MDEL) for Class I, II, III, or IV medical or surgical devices, IVD, How medical devices are classified in Japan. The term “medical device” covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada Guidance for the Labelling of Medical Devices Guidance Document Date Adopted: 2004/06/12; Effective Date: 2015/07/16 1 1.0 INTRODUCTION 1.1 Policy Objective To assist manufacturers of non-in vitro diagnostic devices in complying with the labelling requirements under sections 21 - 23 of the Medical Devices Regulations (Regulations).
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