Authorized Representative Medical Devices

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Authorised Representatives – The European Union …

https://eumdr.com/authorised-representatives/

An authorised representative will have to cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices. The authorised representative will be …

Medical device Authorized Representative, US FDA …

https://medicaldevices.freyrsolutions.com/authorized-representative

A Medical Device authorized representative is any natural or legal person having a local entity in the territory, who is explicitly designated by the manufacturer, acts and may be …

Authorised Representatives, Importers and Distributors - Public …

https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations/authorised-representatives-importers-and-distributors_en

The Regulations clarify the respective responsibilities of authorised representatives, importers and distributors, as well as the tasks that could be delegated by the legal …

Factsheet for Authorised Representatives, Importers and …

https://health.ec.europa.eu/system/files/2020-09/importersdistributors_factsheet_en_0.pdf

Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. They must keep the UDIs for …

Who Must Register, List and Pay the Fee | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201 (h) of the Federal Food, Drug, and …

Article 11 - Authorised representative - Medical Device …

https://www.medical-device-regulation.eu/2019/07/08/mdr-article-11-authorised-representative/

An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent …

Medical Devices EU Authorised …

https://www.compliancegate.com/medical-devices-authorised-representative/

In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the …

Authorised Representative Medical Devices - Easy Medical Device

https://easymedicaldevice.com/authorised-representative-medical-devices/

Unlock the full potential of your medical device (s) in the EU, Swiss, and UK markets with our expert representation services. Get a free, no-obligation, tailor made solution today …

All About Medical Device Authorized Agent / Representative

https://cliniexperts.com/all-about-medical-device-authorized-agent-representative/

An “authorized agent” for medical device is an Indian person or entity appointed by a foreign company to represent that organization in India. The authorized …

Apply for registration of a Refurbished Medical Device, Malaysia

https://morulaa.com/south-east-asia-medical-device-registration/medical-device-authority-manufacturer-authorized-representative-refurbished/

Refurbished medical devices must be registered via the Medical Device Centralized Online Application System, with the manufacturer or authorized representative in …

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