Opinions on devices under special procedure for notified bodies
Показать связи →Notified body must seek Fimea’s opinion if EMA opinion is not required.
Издатель: Fimea · Государственная организация
Язык описания: Английский
Охват: Вся Финляндия
Об услуге
Описание
If a device incorporates, as an integral part of its operation, an ancillary medicinal substance or companion diagnostics, the notified body must, as part of the conformity assessment process, request the opinion of a competent pharmaceutical regulatory authority on the device. The notified body can request an opinion from Fimea in cases where an opinion should not be requested from EMA. The opinion is mandatory and must be considered as part of the certification decision made by the notified body.
Как пользоваться
Medical devices incorporating a medicinal substance Dossier: - A cover letter, EMA’ application form (pages 6–17 completed), information about the medical device, a declaration signed by a qualified expert and CV, report of the notified body on the benefits of adding the medicinal substance component, and device labels. - Quality and clinical summary - The appropriate quality documentation, CEP/ASMF/PMF - The appropriate preclinical documentation - The appropriate clinical documentation Companion diagnostics Dossier - Application form (without page 5) - Draft instructions for use (IFU) - Draft safety and performance summary
Информация об оплате
The fee for statements is based on the current Decree on fees chargeable by the Finnish Medicines Agency
Где и как получить помощь
Requesting an opinion, devices with a special additional procedure · Электронная услуга
As part of the conformity assessment process, the notified body must request an opinion from the competent pharmaceutical authority.
Описание: Английский · Языки обслуживания: Шведский, Английский, Финский
Актуальные часы работы, исключения, требования к идентификации и контакты указаны на официальной странице услуги.