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Medical Devices

Medical Devices

LEPU Medical serves the medical field in both laboratory consumables and medical devices. As medical device supplier, we provide wide range from cardiovascular interventional products, ECG & Patient Monitor, Hemodialysis products, surgical products, IVD products, to orthopedic products.

Medical Device FAQs

Q. What Are General Controls For Medical Devices ?
A.

General controls are fundamental provisions to ensure the safety and effectiveness of regulatory devices. It includes provision for adulteration, misbranding, device registration, notifications for repair / replacement or refund, premarket notifcation, records reports, and good manufacturing practices.

Q. What are Special Controls for Medical Devices?
A.

Special controls are additional controls to general controls for reasonable safety and usability assurance, which includes specific labeling such as usage methods, guidelines, recommendation etc.; performance standards; post-market monitoring; patient registration and more.

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