CE marking for Class I medical devices: Can I self-certify my product?
Many manufacturers assume that Class I medical devices can [...]
How to comply with regulated cosmetic ingredients in Switzerland
Switzerland has its own legal framework for cosmetic products, which [...]
New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant [...]
Australia: New opportunities for medical device and IVD manufacturers
The Therapeutic Goods Administration (TGA) continues to modernize Australia's regulatory [...]
MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has [...]
How to Ensure the Safety of Mobility Devices with Lithium Batteries: MHRA Recommendations
Lithium batteries are a critical technology for powering mobility devices [...]
Amendment to the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) and the Medical Devices Ordinance: Update 2025
As of January 1, 2025, the amended Swiss Ordinance on [...]
Arab Health 2025: Join Us in Dubai!
We’re excited to announce our participation in Arab Health 2025, [...]
Public Consultation on the Evaluation of EU Regulations for Medical Devices and In Vitro Diagnostics: Have Your Say!
The European Commission has initiated a public consultation to [...]
Master UDI-DI for Contact Lenses: What Manufacturers Need to Know
Learn about the new Master UDI-DI for contact lenses: [...]
