Competent Authority (CA)

« Back to Glossary Index

Competent Authority (CA) is a regulatory body or government agency responsible for enforcing and ensuring compliance with regulations related to a specific industry or product. In the medical device industry, the CA is typically the national authority responsible for overseeing the safety and effectiveness of medical devices sold within their respective countries.

The CA is responsible for various tasks, including reviewing and approving medical device applications, conducting inspections, enforcing regulations, and investigating incidents of non-compliance. They play a crucial role in ensuring that medical devices meet the necessary safety and quality standards to protect public health.