Medical Device Registration in Brazil
Medical Device Registration in Brazil Medical Device Registration in Brazil: Grouping for submission Interested to know how to group and hence determine the number of submission is needed in Brazil…
Medical Device Registration in Canada
Medical Device Registration in Canada Now you may ask is it possible to perform medical device registration in Canada without engaging a local company? The answer is yes!First of all…
HSA requirement in 2024: SAC accreditation for ISO 13485 certificate
HSA has expressed that they would be implementing a SAC Accreditation requirement on certification bodies who are issuing ISO 13485 for Singapore manufacturers tentatively in the year 2024.Although this requirement…
Vietnam MOH Note 742 on 29 Jan 2021
Vietnam MOH has indicated in their note 742 on 29th Jan 2021 that they plan to release approvals in 2021. See more info here. MINISTRY OF HEALTH-------SOCIALIST REPUBLIC OF VIETNAMIndependence -…
Medical Device Registration in Pakistan
Medical Device Registration in Pakistan Click here to visit DRA (Authority) website. Contact us here for more information on medical device registration in Pakistan Status of registration (as of…
Medical Device Registration in Thailand
Medical Device Registration in Thailand (updates and news) Latest CSDT requirements as of Feb 2021 1 Executive summary1.1 "overview - explanation in general for this producthave information of concentration and…
Medical Device Registration in Ukraine
Medical Device Registration in Ukraine: Requirement list EU Certificate of conformity Essential requirements LabelInstruction for use(for III class) Design examination certificateEU Declaration of conformity 2. Technical file (STED) with informationGeneral description of medical…
Free ISO 13485 Customer Communication Template
Free ISO 13485 Customer Communication Template You can buy the ISO 13485 standard here. Please Like our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe us on youtube and comment hereANDemail us here from your work email (verifiable domain from…
Free ISO 13485 Software Validation Template
Free ISO 13485 Software Validation Template You can buy the ISO 13485 standard here. Please Like our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe us on youtube and comment hereANDemail us here from your work email (verifiable domain from…
Free ISO 13485 Risk Management Template
Free ISO 13485 Risk Management Template You can buy the ISO 13485 standard here. Please Like our facebook page and comment here ORLike us on Google and comment here ORLike and subscribe us on youtube and comment hereANDemail us here from your work email (verifiable domain from…
