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Location | Switzerland |
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Swiss authorised representative (CH-REP) - Swissmedic
Use of the “CH-REP” symbol on the packaging. The name and address of the authorised representative must appear adjacent to the symbol. The address must enable contact to be established with the Swiss authorised representative. It is not sufficient only to state the P.O. box number, an e-mail address or a telephone number.
Swissmedic.chDA: 17 PA: 50 MOZ Rank: 78
Contact - Swissmedic
Monday - Thursday. 08:00 –12:00. 13:30 – 16:30. Friday. 08:00 –12:00. 13:30 – 16:00. We are able to answer straightforward questions by telephone immediately. If your question is more complex and you need a personalized response, please submit it in writing either via our contact form or in the form of a letter or fax. Swissmedic.
Swissmedic.chDA: 17 PA: 41 MOZ Rank: 59
May 2022 - swissmedic.ch
01.05.2022. ZL000_00_044e_WL Guidance document Authorisation procedures for Covid-19 medicinal products during a pandemic (PDF, 325 kB, 01.05.2022)
Swissmedic.chDA: 17 PA: 50 MOZ Rank: 83
Swissmedic - Swiss Agency for Therapeutic Products
Swissmedic is the regulatory agency responsible for authorizing and supervising therapeutic products in Switzerland. Based in Bern, the agency started its activities on 1 January 2012, replacing the Interkantonale Kontrollstelle für Heilmittel (IKS). It was created by the Federal Act on Medicinal Products and Medical Devices and is attached to the Federal Department of Home …
Emergobyul.comDA: 18 PA: 40 MOZ Rank: 61
Arzneimittelinformation
Mit der Nutzung der AIPS-Plattform der Stiftung Refdata stimmen Sie den untenstehenden Nutzungsbestimmungen ausdrücklich zu.
Swissmedicinfo.chDA: 17 PA: 17 MOZ Rank: 22
Swissmedic Swiss Agency for Therapeutic Products
Swissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic Products. Unlike medicinal products, medical devices do not undergo an official authorisation procedure. Swissmedic's focus in the area of medical devices is thus on effective ...
Opendata.swissDA: 14 PA: 27 MOZ Rank: 46
Information sur le médicament - swissmedicinfo.ch
En utilisant la plate-forme AIPS de la Fondation Refdata, vous acceptez expressément les conditions d'utilisation énoncées ci-dessous.
Swissmedicinfo.chDA: 21 PA: 21 MOZ Rank: 28
Swiss Authorized Representative, CH-REP, Swiss AR, Swissmedic
The Swissmedic’s Medical Device Ordinance (MedDO) requires all foreign (non-Swiss) device manufacturers to appoint a Swiss Authorized Representative (Swiss AR) to place device products on the Switzerland market. The Swiss AR must represent a foreign manufacturer concerning the responsibilities specified in MedDO.
Ch-repservices.comDA: 22 PA: 22 MOZ Rank: 30
Liste Rückrufe Medizinprodukte - Swissmedic
Swissmedic reference; 05.04.2022 (Updated 08.04.2022) Abbott Molecular Inc. Alinity m CMV Amplification Reagent kit Model: 09N46-090 Lot: All IVD: Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) DE-1 EN-1: Vk_20220404_25 08.04.2022 Randox Laboratories Ltd: CK-MB Calibrator Model: CK2393 Lot: 4410CK IVD: Creatine kinase …
Fsca.swissmedic.chDA: 18 PA: 5 MOZ Rank: 31
Swiss Authorized Representative (CH-REP) for Medical Devices
We will guide you on how to comply with the Swiss requirements most efficiently. Advise you on labeling changes to comply with MedDO requirements. Fulfill vigilance and incident reporting requirements required of Swiss AR. Obtain Free Sales Certificates (FSC) from Swissmedic, if needed. MedEnvoy is ISO 13485:2016 certified.
Medenvoyglobal.comDA: 22 PA: 32 MOZ Rank: 63
Swissmedic — Wikipédia
Swissmedic autorise les essais cliniques, la mise sur le marché de médicaments et la libération de lots.Il délivre des autorisations d’exploitation pour la fabrication et le commerce de gros, désigne les organes d’évaluation de la conformité des dispositifs médicaux et …
Fr.wikipedia.orgDA: 16 PA: 16 MOZ Rank: 42
Swissmedic - Crunchbase Company Profile & Funding
Swissmedic is an online shop that offers pain relief, prevention, immunity, cosmetic and skin care products. Search Crunchbase. Start Free Trial . Chrome Extension. Solutions. Products . Resources. Resources. Pricing. Log In. Organization. Swissmedic . Connect to CRM . Save . Summary People Technology Signals & News Similar Companies. About. Swissmedic …
Crunchbase.comDA: 18 PA: 24 MOZ Rank: 53
Swiss medical device regulations, medical device ordinance, CH-REP
Role of Swiss AR/CH-REP. The Swiss AR shall register medical devices with Swissmedic on behalf of the manufacturer, ensure conformity of the device, respond to any queries from Swissmedic and carry out Post-Marketing Surveillance (PMS) activities. Eligibility for being a Swiss AR
Ch-repservices.comDA: 22 PA: 19 MOZ Rank: 53
Swiss economic operators registered at Swissmedic | opendata.swiss
Additional information Identifier https://ogd.swissmedic.ch/mep/CHRNActors.xml Issued date May 26, 2021 Modified date-Languages Language independent
Opendata.swissDA: 14 PA: 50 MOZ Rank: 37
Swiss economic operators registered at Swissmedic | opendata.swiss
Additional information Identifier https://ogd.swissmedic.ch/mep/CHRNActors.csv Issued date May 26, 2021 Modified date-Languages Language independent
Opendata.swissDA: 14 PA: 50 MOZ Rank: 36
Yes, Now You Need a Swiss Importer & Authorized Representative …
Inform Swissmedic, the manufacturer and CH-REP if the importer believes the device does not comply with MedDO . Check that storage and transportation conditions are suitable for the products Maintain a copy of Declaration of Conformity and relevant certificates . Cooperate with Swissmedic as required . Learn more or request a proposal for Swiss Importer services. …
Medenvoyglobal.comDA: 22 PA: 41 MOZ Rank: 78
Swiss Authorized Representatives for Medical Device ... - Decomplix
As communicated in the Notice to Stakeholders issued by the EU Commission, the MRA ceased to apply for medical devices on 26 May 2021, date of application of the new Regulation (EU) 2017/745 on medical devices (EU MDR). As a result, Switzerland is now considered a third country to the effects of the EU MDR. On the same date, Switzerland …
Decomplix.comDA: 13 PA: 50 MOZ Rank: 92
Swissmedic extends the use of remdesivir - Federal Council
The Swissmedic experts based their decision on the existing data on quality and manufacturing, non-clinical (preclinical) safety tests, clinical trial data and supplementary safety information obtained from the use of remdesivir in the compassionate use programmes. A broad-based clinical trial with the active substance remdesivir in the USA found that the benefit-risk profile …
Admin.chDA: 12 PA: 50 MOZ Rank: 89
Swiss Authorized Representative, CH-REP, Medical devices, …
Under the Swiss MedDO, Swissmedic mandates non-Swiss manufacturers (located outside Switzerland and without any local business offices) to appoint a Swiss Authorized Representative (CH-Rep) or Swiss AR or Swiss Rep on their behalf as a pre-requisite for device registration and launch in Switzerland. Role of a Swiss AR.
Medicaldevices.freyrsolutions.comDA: 33 PA: 13 MOZ Rank: 64
Definitions OGD data
If you have technical questions please send an E-Mail to [email protected] with the note “«Schnittstelle hmd-zl-172-ogd»”. If you have professional questions please send an E-Mail to “[email protected]” with the note “«Schnittstelle hmd-zl-172-ogd»”. Content
Ogd.swissmedic.chDA: 17 PA: 50 MOZ Rank: 88
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