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 Registration in China (Part 2): Documents for the First Filing of Class I Medical Devices
Which documents are needed to file a class I medical device with the NMPA or a local authority – from the filing form and technical requirements to test reports, IFU and manufacturing information.
NMPA Registration in China (Part 1): Class I Medical Devices Explained
Applicable regulations, how to confirm class I status, where domestic and imported class I devices are filed, and how the filing procedure works in China.
NMPA Registration in China: How to Judge the Quality of a Cybersecurity Research Report (Part 2)
Five criteria for assessing a medical device cybersecurity research report – completeness, accuracy, depth, logical coherence – and the standards to reference.
Device Classification and Conformity Assessment Routes under the EU MDR
How the 22 classification rules of MDR Annex VIII work and which conformity assessment routes (Annexes IX, X and XI) apply to class I, Is/Im/Ir, IIa, IIb and III devices.
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…