Globalization and the rapid advance of new technologies have presented a major challenge to regulators worldwide. Highly complex regulatory developments and the globalized production chain have advanced much faster than the availability of financial and human resources in most regulatory authorities.
This blog highlights the importance of regulatory compliance for medical device manufacturers, roadblocks and key steps to navigate through them. Table Of Contents: Medical devices play a crucial role in the healthcare ecosystem, aiding in the diagnosis, treatment,...
This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico. Table of Contents Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary...
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
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