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Canada: Updated guidance on classification for “Device” or “Drug“ products
By Katarzyna Mizerska on 3. May 20180Read moreHealth Canada has issued updated guidance on how it classifies healthcare products that do not readily fall within the...
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Canada: New Reclassification Rules for certain Device Disinfectants And Sterilants
By Katarzyna Mizerska on 3. May 2018Read moreHealth Canada has reclassified from drugs to medical devices high-level disinfectant and sterilant solutions that are intended for use...
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Malaysia: New Guidance on Labelling Requirements for Medical Devices
By Katarzyna Mizerska on 2. May 2018Read moreThe Medical Device Authority (MDA) has prepared a guidance document on labelling requirements for medical devices under the Medical...
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Canada: Adjustments to the Medical Device Single Audit Program (MDSAP) Transition
By Katarzyna Mizerska on 2. May 2018Read moreHealth Canada has been engaging with the medical device industry to support its transition to the new MDSAP program...
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ATTENTION: fake MEDCERT certificates
By Katarzyna Mizerska on 2. May 2018Read moreWe were informed about fake MEDCERT certificates. Please note that these certificates were neither issued by MEDCERT nor are...
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Notified Body
By Katarzyna Mizerska on 16. January 2018Read moreA notified body is an organisation designated by an EU country to assess the conformity of certain products before...
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Press
By Katarzyna Mizerska on 14. December 2017Read moreIn the latest issue of the German Journal for Medical Devices, MPJ-Medizinprodukte-Journal, you find an interview with the Managing...
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„Consequences of the Medical Devices Regulation (MDR) for Notified Bodies and Manufacturers” Interview with our Managing Director, Klaus-Dieter Ziel for the MPJ- Journal for Medical Devices
By Katarzyna Mizerska on 13. December 2017Read moreIn the latest issue of the German Journal for Medical Devices, MPJ-Medizinprodukte-Journal, you find an interview with the Managing...
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MEDCERT: Merry Christmas!
By Katarzyna Mizerska on 13. December 2017Read moreDear customers, business partners and friends! We would like to thank you for another successful year together. We...

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