TERMIUM Plus®
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APPROBATION PREALABLE MISE MARCHE [1 record]
Record 1 - internal organization data 2007-11-26
Record 1, English
Record 1, Subject field(s)
- Marketing
- Prostheses
- Medication
Record 1, Main entry term, English
- premarket approval
1, record 1, English, premarket%20approval
correct
Record 1, Abbreviations, English
- PMA 1, record 1, English, PMA
correct
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 CONT
Pre-market approval (PMA) permits an applicant to market a particular medical device. PMA requirements apply to Class III devices. PMA requirements differ between preamendment and postamendment devices. 2, record 1, English, - premarket%20approval
Record 1, French
Record 1, Domaine(s)
- Commercialisation
- Prothèses
- Médicaments
Record 1, Main entry term, French
- approbation préalable à la mise en marché
1, record 1, French, approbation%20pr%C3%A9alable%20%C3%A0%20la%20mise%20en%20march%C3%A9
correct, feminine noun
Record 1, Abbreviations, French
Record 1, Synonyms, French
- autorisation préalable à la mise en marché 3, record 1, French, autorisation%20pr%C3%A9alable%20%C3%A0%20la%20mise%20en%20march%C3%A9
correct, feminine noun
Record 1, Textual support, French
Record number: 1, Textual support number: 1 CONT
L'approbation préalable à la mise en marché permet à un requérant de commercialiser un dispositif médical particulier. 1, record 1, French, - approbation%20pr%C3%A9alable%20%C3%A0%20la%20mise%20en%20march%C3%A9
Record 1, Spanish
Record 1, Campo(s) temático(s)
- Comercialización
- Prótesis
- Medicamentos
Record 1, Main entry term, Spanish
- aprobación de precomercialización
1, record 1, Spanish, aprobaci%C3%B3n%20de%20precomercializaci%C3%B3n
correct, feminine noun
Record 1, Abbreviations, Spanish
Record 1, Synonyms, Spanish
- autorización para la precomercialización 2, record 1, Spanish, autorizaci%C3%B3n%20para%20la%20precomercializaci%C3%B3n
correct, feminine noun
Record 1, Textual support, Spanish
Record number: 1, Textual support number: 1 CONT
Es posible que la autoridad reguladora local exija para la comercialización del DM (dispositivo médico): Notificación de conformidad precomercialización; Aprobación de precomercialización; Sin requisitos de precomercialización. 1, record 1, Spanish, - aprobaci%C3%B3n%20de%20precomercializaci%C3%B3n
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