Unlocking Global Markets For MedTech Companies | Pure Global

Business

Mastering Mexico’s Complex IVD Regulatory Landscape: A Strategic Guide for Market Success

A comprehensive guide for IVD manufacturers to navigate Mexico's complex COFEPRIS registration process, emphasizing strategic planning, dossier assembly, and ongoing compliance through expert partnership and advanced technology.

RCRan Chen•Aug 9, 2025

#Mexico healthcare#IVD registration#COFEPRIS#Regulatory affairs#Market entry

Business

Mastering Brazil’s New IVD Regulatory Landscape: A Guide for MedTech & HealthTech Companies

This comprehensive guide explores Brazil’s recent regulatory changes for IVD devices under RDC 830/2023, highlighting pathways, documentation, and how to effectively navigate the market with expert support.

RCRan Chen•Aug 9, 2025

#Brazil#IVD Regulation#ANVISA#MedTech#Regulatory Affairs

Business

Mastering Medical Device Approval in South Korea: A Comprehensive Guide for MedTech Companies

A comprehensive guide for MedTech and HealthTech companies to navigate South Korea's complex medical device approval process, emphasizing strategic planning and local expertise.

RCRan Chen•Aug 9, 2025

#Medical Device Approval#South Korea#Regulatory Affairs#MedTech#Market Entry

Business

Mastering Brazil’s Medical Device Market: A Guide to Navigating ANVISA’s Regulatory Landscape for Class II Devices

A comprehensive guide for MedTech and HealthTech companies on navigating the costs, procedures, and strategic considerations for registering Class II medical devices in Brazil under ANVISA’s regulations.

RCRan Chen•Aug 9, 2025

#Brazil medical device regulation#ANVISA#Class II devices#Regulatory compliance#Global market entry

Business

Mastering the Complexities of Medical Device Registration in Saudi Arabia: A Strategic Guide for MedTech and HealthTech Companies

A comprehensive guide for MedTech and HealthTech companies on navigating Saudi Arabia's complex medical device registration process, fee structures, and how strategic partnerships like Pure Global facilitate successful market entry.

RCRan Chen•Aug 9, 2025

#Medical Device Registration#Saudi Arabia#SFDA#Regulatory Compliance#Market Entry Strategy

Business

Mastering Colombia’s Medical Device Registration: A Strategic Guide for MedTech & HealthTech Companies

A comprehensive guide for MedTech and HealthTech companies on navigating Colombia’s complex medical device registration process, with strategic insights and how Pure Global can facilitate success.

RCRan Chen•Aug 9, 2025

#Medical Device Regulation#Colombia Market Entry#INVIMA#Regulatory Strategy#MedTech