Medical Device Regulations and Registration Process in Sweden
Sweden is an EU Member State. That means medical devices here fall under EU MDR (Regulation (EU) 2017/745) and IVDR […]
Regulations
CDSCO Post-Approval Change Applications for Medical Devices
A CDSCO medical device licence is not a finish line. Manufacturing sites move, designs get refined, labels get updated, agents
Veterinary Pharmaceuticals Regulations and Registration in Japan
Japan has a well-defined framework for veterinary medicines. For global regulatory teams and animal health companies, however, meeting the requirements
Managing Label Changes Under IVDR for IVD Manufacturers
Since IVDR came into effect, IVD manufacturers have had to respond to changes across clinical evidence, quality management, vigilance and
UK Cosmetics Regulatory Requirements & Registration Process
A separate UK compliance process now needs to be undertaken to sell cosmetics in Great Britain. Brands that only notify
Cosmetics Regulations & Registration Process in the European Union
Anyone planning to put cosmetics on the EU market must notify the products in accordance with Regulation (EC) No 1223/2009.
How to Use DIGIPRIS for COFEPRIS Regulatory Submissions
In recent years, companies submitting applications in Mexico have had to adjust to a different way of dealing with the
Health Supplements Regulation and Registration In UAE
People across the UAE are paying more attention to diet and nutrition, leading to a sharp rise in food and
COFEPRIS Simplifies Medical Device Registration in Mexico (2025)
New Regulatory Agreement by COFEPRIS for Simplification of Medical Device Registration Procedures and Shorter Timelines in Mexico: The Federal Committee