EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
EU RED Cybersecurity Requirements Soon to Become Mandatory
The European Commission has adopted a delegated act under the Radio Equipment Directive (RED – 2014/53/EU), Delegated Regulation (EU) 2022/30, to strengthen the cybersecurity of internet-connected radio products in the European Union (EU). It applies from 1 August 2025. 1. Implementing three essential requirements of the RED The delegated act activates three essential requirements in…
EU Safety Rules for Medical Device Apps on Online Platforms
Guidance MDCG 2025-4, published by the EU Medical Device Coordination Group in June 2025, provides guidance on the safety of medical device software (MDSW) apps on online platforms. An online platform is a hosting service that, at the request of a recipient of the service, stores and disseminates information to the public. Software applications developed…
FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained
eSTAR (electronic Submission Template And Resource) is the FDA’s electronic submission template tool for medical device 510(k) submissions. It is mainly used to standardise the format and content of submissions so that the FDA can review them efficiently. 01 The home page when the electronic submission template is opened: 02 Submission type 03 The submission…
China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices
1. Core definition and value of real-world data Real-world data (RWD) are data relating to patient health status and routine diagnosis, treatment and care collected from a variety of settings outside traditional clinical trials. Their core value lies in: Supporting regulatory decisions: clinical evidence on device use and risks/benefits derived from analysis of RWD can…
Application Guide for Third-Party Warehousing and Transport Services of Medical Device Distributors
1 Management requirements for third-party warehousing and transport companies Third-party warehousing and transport companies must strictly follow the Good Supply Practice for Medical Devices, establishing quality management rules, a management system, operating procedures and implementation records covering the entire logistics, storage and transport process to ensure the quality and safety of medical devices during storage…
The Complete Australian Medical Device Registration Process Explained
PART 1 Legal basis Core regulation: Therapeutic Goods (Medical Devices) Regulations 2002 (as amended on 14 December 2024) Legal framework: based on the Therapeutic Goods Act 1989, which systematically governs the classification, registration and regulation of medical devices PART 2 Medical device classification PART 3 Compliance route to registration Conformity assessment requirements: Class I devices:…
Detailed Guide to the Medical Device Classification Determination Procedure
1 When classification determination applies An application for classification determination may be made when a medical device product: Is not explicitly listed in the current Medical Device Classification Catalogue Or when the manufacturer disputes or is unsure of the product’s classification 2 Details of the classification determination application process Core procedure 1. Application: log in…
ISO 15223-1:2021/Amd 1:2025 Medical Device Labelling Symbols: Overview and Where to Obtain It
ISO 15223-1 “Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements” specifies standard symbols that may be used on medical device labels, packaging and instructions for use. This page introduces the key points of the 2021 edition and Amendment 1:2025 (Amd 1:2025), and where…
Guide to Writing MDR Technical Documentation
1 Product description and specification 1.1 Basic product information Product name: including the generic name and trade name Basic UDI-DI: state accurately the corresponding code in the UDI database (EUDAMED) Intended patient population: clearly describe the characteristics of the target population (such as age, sex and disease state) Principle of operation: explanation of the mechanism…
Clinical Evaluation Routes and Methods in MDR Certification
Under the EU Medical Device Regulation (MDR 2017/745), all medical devices must undergo clinical evaluation before being placed on the market to demonstrate that they meet the general safety and performance requirements. The MDR sets out multiple clinical evaluation routes, allowing manufacturers to choose the best option for their device. Drawing on MDR 2017/745 and…
US Bans Chinese Laboratories Deemed a “Security Risk” from FCC Certification Testing
On 22 May 2025 (local time), the US Federal Communications Commission (FCC) unanimously (4–0) adopted new rules aimed at preventing so-called “China and other untrustworthy actors” from controlling the testing and certification of wireless devices for the US. The core of the new rules: all laboratories and bodies involved in testing, reviewing and certifying US…
Free Sale Certificate (FSC): A Key Document for Global Medical Device Trade
What a Free Sale Certificate is, why export markets ask for it, how to apply in the EU and what to expect regarding validity and translations.