Medical Device Approval
/ˈmɛdɪkəl dɪˈvaɪs əˈpruːvəl/
Definitions
- (n.) The legal process by which a government agency formally authorizes a medical device to be marketed and used, ensuring it meets safety and efficacy standards.
The medical device approval took two years due to rigorous testing requirements.
Forms
- medical device approval
- medical device approvals
Related terms
See also
Commentary
Medical device approval involves distinct procedures varying by jurisdiction; precise terminology depends on regulatory frameworks such as FDA in the U.S. or EMA in Europe.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.