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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Warnings and counterfeits

03.08.2018

Safety notice: Recall of three varieties of latex-free condoms – Durex Natural Feeling (pack of 10 condoms), Durex Love Collection (pack of 31 condoms) and Durex Natural Feeling Easy Glide (pack of 12 condoms) – produced by Reckitt Benckiser Healthcare (UK) Limited

09.07.2018

Safety Notice: Treatment couches with a MAX60 motor

MAX60 motor series: Mahe E, MAUI E, SAMOA E, SAMOA EE, BALI E, GOZO E1 - E3, Vojta Bobath E by the company Physioline GmbH - The electrically adjustable treatment couches, which are older than 10 years, can sag uncontrollably down

Announcements

01.11.2018

Notification for placing a medical device on the market according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213): Change as of 1 Jan. 2019

Advance notice: Fee for the notification for placing a medical device on the market according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213)

18.10.2018

Events concerning medical devices

Events with speakers from Swissmedic

03.08.2018

(BIA-ALCL) Anaplastic large cell lymphomas in connection with breast implants – updated information

Affected products: Breast implants, all types, makes and models of all manufacturers

18.06.2018

HIV self-test kits now also available in Switzerland

Media release

Updated PDF forms

01.10.2018 

BW540_00_002e_FO Ordering of export certificates and manufacturing certificates for medical devices (PDF, 1 MB, 01.10.2018)

23.08.2018 

BW510_00_004e_FO Clinical Trials with medical devices: Submission for approved trial (PDF, 1 MB, 23.08.2018)

22.08.2018 

BW530_00_004dfe_FO Form for the registration of manufacturers and devices: In vitro diagnostic medical devices, article 10 98/79/EC (PDF, 1 MB, 22.08.2018)

BW530_00_005dfe_FO Form for the registration of information relating to the certification of in vitro diagnostic medical devices (Annexes III to VII) In Vitro Diagnostic Medical Devices 98/79/EC (PDF, 1 MB, 22.08.2018)

Permanent link of this page
www.swissmedic.ch/md-en

Contact

Swissmedic
Division medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Last modification 02.10.2018

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