Unlocking Global MarketsFor MedTech Companies
We combine real-world experience with AI and data to build smart, efficient medical device regulatory consulting solutions for more than 30 markets
All Markets Served
We provide comprehensive regulatory support across major global markets, ensuring your products meet local requirements and standards.
Americas
United States
The world's largest medical device market, accounting for over 40% of the international market.
Canada
Canada relies on imports for approximately 70% of its domestic medical device demand.
Mexico
The second-largest country in Latin America with major urban centers and growing healthcare needs.
Brazil
The heart of Latin America with 214 million people and the eighth largest healthcare market globally.
Colombia
The third-largest medical device market in Latin America with over 50 million people.
Argentina
Home to over 45 million people with imports accounting for approximately 80% of devices.
Peru
With over 34 million people and increasing health sector budget, Peru emphasizes healthcare improvement.
Europe
European Union
The second-largest medical device market globally with nearly 450 million consumers across 27 countries.
United Kingdom
The third-largest medical device market in Europe with nearly 68 million people.
Switzerland
Recognized for its robust medical technology sector with nearly 9 million population.
Middle East & Africa
Israel
Advanced healthcare sector with strong focus on technological innovation.
Saudi Arabia
Significant market with robust economy and population exceeding 35 million.
UAE
Strategic location with robust healthcare infrastructure development.
Egypt
Second-largest medical device market in the MENA region with low local production.
Asia Pacific
China
One of the leading medical device markets globally with rapidly aging population.
Japan
World's second-largest medical device market with over 123 million people.
India
One of the largest and fastest-growing healthcare markets with over 1.3 billion people.
Australia
Significant import market with around 80% of market needs met through imports.
Singapore
Strategic commercial hub in Asia with high GDP per capita and robust healthcare infrastructure.
Malaysia
Significant and growing medical device market in Southeast Asia with over 34 million people.
Thailand
Dynamic medical hub with over 70 million people and strategic ASEAN position.
Indonesia
World's fourth most populous country with over 275 million people.
Philippines
Second most populous country in Southeast Asia with about 117 million people.
Vietnam
Nearly 100 million people with rapid economic growth and expanding healthcare industry.
Taiwan
Nearly 24 million population with focus on biotechnology and medical devices sectors.
Hong Kong
Strategic operational hub with over 7 million people for regional expansion.
Pakistan
Over 240 million people with rapidly increasing healthcare demands.
Bangladesh
Burgeoning population of over 170 million with rapidly expanding healthcare industry.
How We Can Help
Our comprehensive suite of regulatory services ensures your product's successful market entry and ongoing compliance.
Regulatory Strategy and Roadmap
Comprehensive regulatory planning tailored to your product and target markets.
Our experts develop customized regulatory strategies that align with your business objectives, ensuring the most efficient path to market approval.
Technical Documents Compilation
Expert preparation and submission of all required regulatory documentation.
We handle the complex documentation requirements for each market, including technical files, clinical evaluations, and risk management documentation.
Post-Market Surveillance
Ongoing compliance monitoring and vigilance solutions.
Our comprehensive post-market surveillance services ensure continued compliance with evolving regulatory requirements and prompt response to any safety concerns.
Our Global Experts
Pure Global leverages the expertise of medical device and IVD regulatory consultants from around the world. Access key markets, design a global strategy, and solve critical regulatory challenges with support from our experienced team.
Americas
Silicon Valley innovation meets Latin American regulatory mastery. Our team navigates FDA pathways, ANVISA submissions, and emerging AI/ML device regulations.
Europe
From Paris to Stockholm, we deliver MDR compliance, notified body liaison, and strategic market entry across all European territories.
Asia Pacific
Beijing to Bangkok expertise in NMPA submissions, PMDA approvals, and ASEAN harmonization. AI-enhanced regulatory intelligence across APAC.
How to Start
Getting started with Pure Global is simple. Follow these three easy steps to begin your regulatory journey with our proven strategies.
Initial Consultation
Schedule a free consultation to discuss your product and target markets with our regulatory experts.
Strategy Development
We develop a customized regulatory strategy and roadmap tailored for your success across target markets.
Implementation
Our experts handle all documentation and submission processes to ensure smooth market entry.
Get In Touch
Ready to expand into new markets? Contact us today for a free consultation and get personalized guidance.