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