Registro de Dispositivos Sanitarios
Latest news: COFEPRIS reviewers will accept proof of ISO 13485 quality system certification instead of Establishment Inspection Reports (EIRs) issued by the FDA.
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Registro Sanitario de Dispositivos Medicos
BySylvieCelebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !
FDA guidance to help current manufacturing limitations due to disruptions caused by the COVID-19 – FDA to temporarily accept changes to devices approved through PMA or HDE.
BySylvieFor the duration of the public health emergency, FDA does not intend to object to limited modifications to the manufacturing of devices approved through the PMA program or the HDE program, without prior submission of the required PMA or HDE supplement or 30-day notice, where the modification does not create an undue risk in light…
Ya está la nueva ISO13485:2016 !!!
BySylvieYa se publico la nueva norma ISO 13485:2016 !!! http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 Pregunta por nuestro curso ! info@symaconsulting.com
Medical Devices Regulation MDR Postponed.
BySylvieMedical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…
ISO 13485:2015 to be published early 2016
BySylvieReference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…
Medical Devices – Harmonized Standards MDD – New Listing
BySylvieIn March this year, a new list of harmonized standard was published, see the new list in this link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/ You need to download the files now in order to see the list.