№ files_lp_4_process_1_33126
Form providing official instructions for companies to complete and submit Form 2_IDV to the Italian Ministry of Health for registering in-vitro diagnostic medical devices, specifying roles of delegating and authorised companies and required documentation.
Year: 2023
Country: Italy
Ministry: Ministry of Health (Ministero della Salute)
Department: Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico, Ufficio 4
Document Type: Instruction/Guideline
Legal Reference: Ministerial Decree 23 December 2013, Legislative Decree no. 332 of 8 September 2000, Regulation (EU) 2017/746
Target Audience: Delegating and authorised companies registering in-vitro diagnostic devices
Required Attachments: Proof of identity of legal representatives
Submission Method: PDF via email to [email protected]
Data Entry: Appointed responsible person for entering and updating data in “Repertorio”
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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