Regulatory Classification

/ˌrɛɡjʊˈleɪtəri ˌklæsɪfɪˈkeɪʃən/

Definitions

  1. (n.) The categorization of entities, activities, or goods under specific legal or administrative rules that determine applicable regulations and compliance requirements.
    The regulatory classification of the new medical device affects its approval process and market entry conditions.

Forms

  • regulatory classification
  • regulatory classifications

Commentary

Used primarily in administrative and regulatory law to determine how laws and regulations apply; clarity in drafting ensures precise compliance obligations.

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.

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Amicus Docs | Regulatory Classification Definition