Notification of IVDs

Name: Notification of IVDs
Creator: Swiss Agency for Therapeutic Products
Keywords: access,certification,data,diagnostics,faq,forms,frequently-asked-questions,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,in-vitro-diagnostics-regulation,ivd,ivdmd,ivdr,ivds,manufacturers,markets,medical-devices,notification,registrations

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Market Access

Last updated

November 24, 2023

Description

Notification of IVDs for market access.

Organization

Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

Country / Region

Switzerland

License

Other (Non-Commercial)

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32 Main files

Meldung IVD

Updated on September 6, 2023

html

URL: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/marktzugang/meldung-ivd.html
Permalink: https://data.openrid.co/en/datasets/r/1170eae2-7870-4187-a69c-32d7647cb90c
MIME Type: text/html

Created on: September 6, 2023
Modified on: September 6, 2023

BW630_30_030dfe FO Formblatt für die Anzeige der Hersteller gem. Art. 90 Abs. 1 IvDV

Updated on July 25, 2022

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_030dfe_fo_ext_formblatt_art90_abs1_ivdv.pdf.download.pdf/BW630_30_030dfe_FO_ext_Formbl_Art90_Abs1_IvDV.pdf
Permalink: https://data.openrid.co/en/datasets/r/e3bcb377-8b4c-42fa-98ac-dea5eca10697
MIME Type: application/pdf

Created on: July 25, 2022
Modified on: July 25, 2022

BW630_30_031dfe FO Formblatt für Zertifizierungsdaten von In-vitro-Diagnostika Art. 90 Abs. 1 IvDV (IVDR Annexes IX - XI)

Updated on May 26, 2022

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_031dfe_fo_ext_formblatt_zertifizierungsdaten_art90_abs1_ivdv.pdf.download.pdf/BW630_30_031dfe_FO_ext_Formbl_Zert_Daten_Art90_Abs1_IvDV_IVDR_Anh_IX_XI.pdf
Permalink: https://data.openrid.co/en/datasets/r/9dfc5156-fd9c-499a-9d0f-718deccfc32f
MIME Type: application/pdf

Created on: May 26, 2022
Modified on: May 26, 2022

BW630_30_029d_FO Meldung nach Art. 46 Abs. 4 und Art. 47 Abs. 4 IvDV von umgepackten / umgekennzeichneten In-vitro-Diagnostika

Updated on May 26, 2022

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_029d_fo_umgepackte_umgekennzeichnete_ivd.pdf.download.pdf/BW630_30_029d_FO_umgepackte_umgekennzeichnete_IVD.pdf
Permalink: https://data.openrid.co/en/datasets/r/957261c9-6b06-44ea-8936-5cf339e6830f
MIME Type: application/pdf

Created on: May 26, 2022
Modified on: May 26, 2022

Beispielliste Art. 46/47 IvDV

Updated on May 26, 2022

xlsx

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/beispielliste_art_46-47_ivdv.xlsx.download.xlsx/Beispielliste%20Art%2046_47%20IvDV.xlsx
Permalink: https://data.openrid.co/en/datasets/r/7dd7a757-5ac9-4b31-a32f-f5ad85974d63
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 26, 2022
Modified on: May 26, 2022

BW630_30_032d FO Formular Meldung nach Art. 10 IvDV für in Gesundheitseinrichtungen hergestellte Produkte

Updated on January 11, 2023

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw630_30_032d_fo_art10_ivdv_in_house.pdf.download.pdf/BW630_30_032d_FO_Art10_IvDV_in_house_IVD.pdf
Permalink: https://data.openrid.co/en/datasets/r/7dba1fa2-f336-45f7-91db-6ccdd1440cc8
MIME Type: application/pdf

Created on: January 11, 2023
Modified on: January 11, 2023

See the 32 main files

Notification of IVDs

Information

Type

Regulated products

Topics

Last updated

Description

Tags

Organization

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