EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
New EU Rules Explained (Part 1): The European Accessibility Act – Directive (EU) 2019/882
Scope, accessibility requirements, obligations of economic operators and service providers, exemptions, market surveillance and timelines of the European Accessibility Act.
Electronic Submissions at FDA and NMPA: Similarities and Differences
How FDA eCopy and eSTAR compare with China’s NMPA eRPS system for medical device submissions – purpose, scope, functions and submission routes.
FDA Medical Device User Fees for FY2025 Explained
FY2025 FDA user fees for 510(k), PMA and annual establishment registration, how payment works, and how to qualify as a small business for reduced fees.
NMPA Registration in China (Part 3): Registering Class II and Class III Medical Devices
Regulations, classification, combination products, registration routes, dossier requirements and registrant obligations for class II and III medical devices in China.
NMPA Guidelines for Registration Review of Radiofrequency Beauty Equipment – Download
This resource is the “Guidelines for Registration Review of Radiofrequency Beauty Equipment” issued by the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA). It is an important technical basis for registering RF beauty products as Class III medical devices in China. The guidelines are intended to guide registration applicants in preparing…
EVERBIZ and Suzhou Sosine Obtain IMQ’s First MDR Certificate in China
Sosine (Suzhou) Medical Technology Co., Ltd. was founded in January 2016 and is headquartered in Suzhou Industrial Park, with branches including innovation institutes and internet hospitals in Beijing, Nanjing, Chengdu and elsewhere. It is a high-tech company focused on the development of flexible wearable medical devices, intelligent medical testing and the application of AI technology…
US 21 CFR Part 820 Quality System Regulation (Version as of 11 September 2024) – Download
This resource is the version of US Title 21 of the Code of Federal Regulations, Part 820 (21 CFR Part 820), as of 11 September 2024 – the medical device Quality System Regulation (QSR). About this document Please note: the FDA has published a final rule amending 21 CFR Part 820 into the Quality Management…
EUDAMED User Guide for Economic Operators – Download
This resource is the English version of the EUDAMED (European Database on Medical Devices) User Guide for Economic Operators published by the European Commission. About this document EUDAMED is the EU medical device database established under the MDR and IVDR. Manufacturers, authorised representatives and importers must register their actor roles in it, obtain a Single…
BS EN ISO 10993-1:2020 Biological Evaluation of Medical Devices: Overview and Where to Obtain It
ISO 10993-1 “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process” is the foundational standard for medical device biocompatibility evaluation. BS EN ISO 10993-1:2020 is the European adoption published by the British Standards Institution (BSI), corresponding to the international standard ISO 10993-1:2018. About the standard The standard requires…
NMPA Guideline for Registration Review of Human Factors Design of Medical Devices – Download
This resource is the guideline on review of human factors (usability) design of medical devices issued by the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA). About this document Human factors design focuses on use errors that may occur when users interact with a device, and the associated risks. The guideline…
EVERBIZ Austria Receives Ministry of Health Authorisation
In May 2023, EVERBIZ Austria, based in Salzburg, received authorisation from the Austrian Ministry of Health and approval in the European medical device database EUDAMED, obtaining its own SRN (Single Registration Number).
IVDR Training for Danaher’s Cepheid Successfully Completed
On 10 February 2023, EVERBIZ was honoured to be invited by Danaher’s Cepheid to deliver EU IVDR training to its regulatory affairs department. At the training, our trainer drew on many years of IVD industry experience to introduce the background and fundamentals of the IVDR, and analysed step by step the risk classification of IVD…