Germany's agency, the Paul-Ehrlich-Institut, administers the approval process for healthcare products. Manufacturers of devices must fulfill strict rules to ensure the safety and performance of their offerings. Key requirements include {pre-market notification, a comprehensive technical documentation, and ongoing monitoring to confirm product per… Read More

Importing healthcare products into India requires a thorough understanding of the regulatory landscape and a meticulous adherence to established procedures. This step-by-step manual aims to demystify the process, outlining the key requirements, regulations, and documentation needed for a smooth registration of medical devices into the Indian market… Read More