FAQ
Medical Devices

EIRs issued by a European Union (EU) notified body are required as attachments for a EU simplified QSD application. Which notified bodies of the EU can issue such a document?

刊登日期:2019-07-11  |  點閱次數 : 93 次 

According to FDA announcement dated July 26, 2018 , for medical devices, four domestic notified bodies and 10 European Union notified bodies have signed the TCP-II agreement. Therefore, the EIR report issued by these 10 European notified bodies (BSI PS, G-med, MDC, TÜV PS, TÜV Rheinland PS, DEKRA, DGM, MEDCERT, SGS (UK), UL (UK)) can be used to simplify QSD application process (in accordance with Paragraph 5 of Article 7 of the Regulations of Medicament Manufacturer Inspections).

 

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