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
Regulatory News
Global medical device regulatory updates and registration guides
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
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:
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
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:
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
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
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.
An Introduction to OTC Drugs Under FDA Regulation
How the FDA regulates over-the-counter drugs, which documents are typically needed, and how the OTC monograph route differs from an NDA.
The EU Authorised Representative: Role, Duties and How to Choose One
Why non-EU manufacturers need an EU authorised representative under the MDR, which tasks the AR performs, and five criteria for choosing the right partner.