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Hi Michelle, Your AR and consultant are right, SFDA requests to provide their local Essential Principles of Safety and Performance (Annex 1 MDS – REQ 1). Even though they are very similar to MDR GSPR, SFDA wants it in their own template. ------------------------------ Emilia Spallanzani QA&RA Manager ...

Hi Anon, From my experience so far there is no difference in the TD of different MDs risk classes in Saudi. Same registration effort for a class A than a class D plus the coming UDI requirements. Best regards, ------------------------------ Emilia Spallanzani QA&RA Manager Germany --------- ...

Hi Barry, Main information can be found in the Medical Device Division website (https://www.mdd.gov.hk/en/home/index.html) or you can contact them, they are nice and give feedback. Also the MDD is frequently providing workshops on this topic, check for new dates here https://www.mdd.gov.hk/en/wha ...

Dear Rashmi, From my experience I can confirm this, labeling (IFU+label) for medical devices in Taiwan must be in traditional Chinese. Regards, ------------------------------ Emilia Spallanzani QA&RA Manager Paul Hartmann AG - ENTERPRISE Heidenheim Germany ------------------ ...