December 12th till December 16th https://school.easymedicaldevice.com/product/gb.
#easymedicaldevice #medicaldevice #regulatorycompliance.
► Rest of the globe.
USA: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox).
USA: MedSun Newsletter – November 2022.
Canada: List of identified criteria for clinical tools:.
Canada: November 8, 2022 updates to listing of clinical tools for compulsory lack as well as discontinuation coverage.
Barhain: Reminder Regarding Deadline for Medical Devices as well as Supplies Authorized Representatives Registration.
– https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and also Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124. pdf.
Call us at EO@easymedicaldevice.com if you look for an Authorized Representative or Importer in the European location.
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi.
■ Twitter: https://twitter.com/elazzouzim.
■ Pinterest: https://www.pinterest.com/easymedicaldevice.
■ Instagram: https://www.instagram.com/easymedicaldevice.
– https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers as well as Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124. – Episode 206: ** Regulatory Pathway: How to get to the United States market?
– Episode 205: ** Your Software/IVD medical record is totally WRONG! https://podcast.easymedicaldevice.com/205/.
– Episode 206: ** Regulatory Pathway: How to get to the United States market?
– Episode 207: ** Why Risk Management is essential to Medical Device advancement? https://podcast.easymedicaldevice.com/207-2/.
Episode 208: ** How to select the very best Sterilization Method for Medical Devices? https://podcast.easymedicaldevice.com/208-2/.
► Social Media to adhere to.
► HOT TOPICS
Usual specs for the teams of items without a desired clinical objective noted in Annex XVI to Regulation (EU) 2017/745
Reclassification of teams of specific energetic items without a desired clinical objective
Upgraded info pack for prospect EU referral research laboratories released
51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD)).
MDCG 2022-16: Guidance on Authorised Representatives Regulation.
New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic).
UK MHRA: Borderline items: just how to inform if your item is a clinical gadget: New area included ‘Risk category of clinical tools’.
Swissmedic: Plan to approve FDA items in Switzerland.
Finland: Power power outages do not call for unique readiness steps from the customers of medications and also clinical gadgets.