Meeting EU Regulations: Role of the European Authorized Representative (EAR)
When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States, compliance […]
MedTech Insights
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Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate, Medical
Class III Medical Devices: Meaning, Examples, Approval Process
FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules and regulations as every one of you would
Types Of Medical Devices & Medical Device Classification System
As we know, the healthcare system and medical devices are co-dependent. The safety and effectiveness of medical devices matters when
Class II Medical Devices: Meaning, Requirements, Process
Running the healthcare system without the use of medical devices is nearly impossible. Medical devices have become an integral part
Class I Medical Device: Regulatory Classification
In the US, Center For Devices And Radiological Health (CDRH) which is a branch of FDA is the regulatory body
Medical Devices Regulation With PFDA In Philippines
In the Philippines, the medical device industry relies heavily on imports for its products. Whether these products are made
Medical Devices Regulations in Hong Kong
Hong Kong’s vibrant medical and healthcare equipment and devices sector primarily focuses on catering to the needs of the household
Medical Device Registration in USA by US FDA
The responsibility for overseeing the regulations of medical device companies involved in the production, repackaging, relabeling, and medical device registration