COFEPRIS Makes Changes to Revamp Medical Device Regulations
Medical Devices Categories Experience
Active Implantable Medical Devices
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Implantable cardiac pacemakers and accessories
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Implantable neurostimulator systems
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Brachytherapy systems
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Cochlear implants and accessories
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Implantable glucose monitors
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Implantable defibrillators
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Leads, electrodes, adaptors for implantable pulse generators
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Ventricular Assist Devices (VADs)
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Implantable infusion pumps
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Micro Electro-Mechanical Systems (MEMS)
Combination
Device
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Electroporation device
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Derma abrasion device with cosmetics
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Insulin pen device
Diagnostics
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Medical imaging
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Optical Tissue Imaging System (OTIS)
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Intraoral dental 3D scanner
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Medical endoscopes, ultrasound
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Refrigerated centrifuges for blood
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Implantable defibrillators
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Non-refrigerated centrifuges for blood
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Blood collection vacuum tubes
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Blood sampling devices
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Thermometers
Mobile devices
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Integrated device
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Video capsule endoscopy
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Devices for artificial limbs
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Implanted wireless sensors and devices
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Wearable wireless sensors
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and devices
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Mobile apps
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Ingestible sensors
Vascular
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Cardiac electrophysiology and ablation catheters
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Catheters for intravascular and intracardiac imaging
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Devices for the treatment of Abdominal Aortic Aneurysms (AAA), neurovascular diseases; structural heart defects or disease
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Drug-eluting stents, bare metal stents, and bioresorbable stents
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Embolic filters and IVC filters
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Guide catheters, balloon catheters, CVCs, introducers, filters, guidewires, PICCs, and related tools
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Renal artery denervation devices
Orthopedic
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Suture anchors
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Surgical spoons
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Angled jaws and instrument trays
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Orthopaedic
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Implants
SaMD
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Infusion pump rate setting assistance software
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Picture Archiving and Communication Software (PACS)
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Image processing software
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Standalone application software for collecting patient data
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Standalone software for implantable devices
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Apps for phones (e.g., ECG, radiation therapy planning software)
Ophthalmic
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Contact lenses
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Lens care products
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Diagnostics
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Implants
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Intraocular lenses
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Lasers
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Phacoemulsification systems
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Solutions (including artificial tears)
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Surgical instruments