Biologics and Biosimilars Regulations and Registration in Brazil
According to the Drugs Sector Regulation Chamber (CMED) in 2022, the Brazilian pharmaceutical sector generated US $17.2 billion in sales […]
Case Study: Regulatory Contract Staffing for a US Based Biotech Company
Artixio provides expert regulatory staff on contingent and contract basis to pharmaceutical and other lifesciences industries using both its in-house
Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices in
What Is Structured Product Labeling (SPL)?
Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard document used
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
Medical Devices Types & Regulatory Classification
If you’re dealing with medical devices from a regulatory or market-entry point of view, understanding classification is not optional —
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