Unlocking Global Markets For MedTech Companies | Pure Global

Seamless Transition: Moving from Distributor-Dependent to Independent Local Representation in Brazil’s Medical Device Market

Learn how to transition from using your distributor as your Brazilian Local Representative to appointing an independent LR with expert guidance from Pure Global, ensuring compliance, control, and growth in Brazil’s medical device market.

RCRan Chen•Aug 8, 2025

#Brazil regulatory compliance#Medical device registration#ANVISA#Local Representation#Regulatory Affairs

Business

Strategic Pathways for In Vitro Diagnostic (IVD) Companies to Successfully Enter the US Market

A comprehensive guide outlining the best strategies for IVD companies to successfully enter and succeed in the US market, covering regulatory, clinical, and commercial considerations.

RCRan Chen•Aug 1, 2025

#IVD#US Market Entry#Regulatory Strategy#Diagnostics#Healthcare

Business

Understanding ISO 13485: The International Standard for Medical Device Quality Management Systems

An in-depth overview of ISO 13485, the international standard for quality management systems in the medical device industry, covering its purpose, components, benefits, and certification process.

RCRan Chen•Aug 1, 2025

#ISO 13485#Medical Devices#Quality Management System#Regulatory Compliance#Healthcare

Healthcare & Medical Devices

Top Tips for Saving Money When Registering Medical Devices in International Markets

Discover effective strategies to reduce costs and streamline the registration process of medical devices across global markets.

RCRan Chen•Apr 27, 2024

#Medical Devices#Regulatory Compliance#International Market#Cost Saving

Regulatory Affairs

How to Navigate Medical Device Registration in Different Countries: A Simple Guide for Beginners

A beginner-friendly guide to understanding and managing medical device registration processes across various countries.

RCRan Chen•Apr 27, 2024

#Medical Devices#Regulatory Compliance#Global Markets