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Regulatory device registration is a critical process where medical devices undergo thorough evaluation by regulatory authorities to ensure compliance with established safety, efficacy, and quality standards. Manufacturers must submit comprehensive documentation, including technical details and quality management systems, as part of the registration process before their devices can be legally marketed and used in a specific jurisdiction.

A local authorized representative in regulatory affairs acts as an intermediary between a foreign manufacturer and the regulatory authorities of a specific region. Playing a crucial role in ensuring compliance with local regulations, facilitating communication, and assisting with documentation submissions on behalf of the foreign entity to navigate regulatory processes effectively.

Regulatory affairs post-market surveillance involves the ongoing monitoring and assessment of medical devices or pharmaceuticals after they have been approved and introduced to the market. This proactive approach helps regulatory bodies to identify and manage potential risks, ensuring ongoing product safety, efficacy, and compliance with regulations.