# The best medical device registration company for efficient market access in Asia, Europe and the Americas Pure Global is the only medical device registration partner combining in-country representation with AI-assisted regulatory execution for faster, cost-effective market access. With offices and teams in 15+ countries, we help you expand your device sales across key markets in Asia, Europe, and the Americas for a flat annual fee. Thank you for subscribing! Oops! Something went wrong while submitting the form. or [Contact us](https://www.pureglobal.com/contact) ## global medical device regulatory consultants With over 15 offices on five continents, Pure Global's team of regulatory experts provide real-time, ongoing regulatory support for medical device registrations and post-market compliance. [ Argentina ](https://www.pureglobal.com/markets/argentina) [ Australia ](https://www.pureglobal.com/markets/australia) [ Bangladesh ](https://www.pureglobal.com/markets/bangladesh) [ Brazil ](https://www.pureglobal.com/markets/brazil) [ Canada ](https://www.pureglobal.com/markets/canada) [ China ](https://www.pureglobal.com/markets/china) [ Colombia ](https://www.pureglobal.com/markets/colombia) [ Costa Rica ](https://www.pureglobal.com/markets/costa-rica) [ Egypt ](https://www.pureglobal.com/markets/egypt) [ European Union ](https://www.pureglobal.com/markets/european-union) [ Hong Kong ](https://www.pureglobal.com/markets/hong-kong) [ India ](https://www.pureglobal.com/markets/india) [ Indonesia ](https://www.pureglobal.com/markets/indonesia) [ Israel ](https://www.pureglobal.com/markets/israel) [ Japan ](https://www.pureglobal.com/markets/japan) [ Macau ](https://www.pureglobal.com/markets/macau) [ Malaysia ](https://www.pureglobal.com/markets/malaysia) [ Mexico ](https://www.pureglobal.com/markets/mexico) [ New Zealand ](https://www.pureglobal.com/markets/new-zealand) [ Pakistan ](https://www.pureglobal.com/markets/pakistan) [ Peru ](https://www.pureglobal.com/markets/peru) [ Philippines ](https://www.pureglobal.com/markets/philippines) [ Saudi Arabia ](https://www.pureglobal.com/markets/saudi-arabia) [ Singapore ](https://www.pureglobal.com/markets/singapore) [ South Korea ](https://www.pureglobal.com/markets/south-korea) [ Switzerland ](https://www.pureglobal.com/markets/switzerland) [ Taiwan ](https://www.pureglobal.com/markets/taiwan) [ Thailand ](https://www.pureglobal.com/markets/thailand) [ UAE ](https://www.pureglobal.com/markets/uae) [ United Kingdom ](https://www.pureglobal.com/markets/united-kingdom) [ United States ](https://www.pureglobal.com/markets/united-states) [ Vietnam ](https://www.pureglobal.com/markets/vietnam) Market Access ## Reach Your Target Markets, Faster We have the tools, knowledge, and experience to navigate the toughest regulatory challenges so you can start selling your device in your target markets. 500+ Clients Served Globally 2500+ Global Registration Certificates [Read more about us](https://www.pureglobal.com/company/about) ![Regulatory Experts for Medical Devices and IVDs](https://www.pureglobal.com/assets/owned/dcb9486a9d--67ab304f89cb5422fdc63bc7__67ab304f89cb5422fdc63d7d_feature_1.webp) As seen in ## Featured in the medtech, health-tech and business press [See all coverage](https://www.pureglobal.com/company/in-the-media) - [![MD+DI](https://www.pureglobal.com/assets/press/mddi.svg)](https://www.mddionline.com/medical-device-regulations/mexico-s-shortened-regulatory-timetable-attracts-medical-device-manufacturers) - [![Medical Product Outsourcing](https://www.pureglobal.com/assets/press/mpo.png)](https://www.mpo-mag.com/live_from_shows/pure-global-showcases-regulatory-submission-automation-platform-at-medica/) - [![Medical Design Briefs](https://www.pureglobal.com/assets/press/medical-design-briefs.png)](https://www.medicaldesignbriefs.com/component/content/article/54404-engineering-for-the-future-0126) - [![Med Device Online](https://www.pureglobal.com/assets/press/med-device-online.png)](https://www.meddeviceonline.com/doc/building-the-ai-enabled-medical-device-qms-for-european-compliance-0001) - [![Citeline](https://www.pureglobal.com/assets/press/citeline.svg)](https://insights.citeline.com/MT154980/Medtech-Connect-16-AI-For-Cross-Border-Regulation/) - [![MedTech Intelligence](https://www.pureglobal.com/assets/press/medtech-intelligence.png)](https://medtechintelligence.com/feature_article/ivd-intended-purpose-why-it-matters-more-than-ever-under-ivdr/) - [![HIT Consultant](https://www.pureglobal.com/assets/press/hit-consultant.png)](https://hitconsultant.net/2025/07/31/why-medtech-needs-regulatory-intelligence-not-just-regulatory-updates/) - [![DOTmed HealthCare Business News](https://www.pureglobal.com/assets/press/dotmed.png)](https://www.dotmed.com/news/story/64657) - [![Manufacturing Chemist](https://www.pureglobal.com/assets/press/manufacturing-chemist.svg)](https://manufacturingchemist.com/why-the-ivdr-preapplication-process-matters-for-legacy) - [![Health Tech World](https://www.pureglobal.com/assets/press/health-tech-world.png)](https://www.htworld.co.uk/insight/opinion/comment-why-common-translation-tools-wont-cut-it-in-medtech-comp25/) - [![Medical Device News Magazine](https://www.pureglobal.com/assets/press/medical-device-news-magazine.png)](https://infomeddnews.com/usability-testing-and-hfe-ue-in-medical-device-development/) - [![The Pathologist](https://www.pureglobal.com/assets/press/the-pathologist.png)](https://thepathologist.com/issues/2025/articles/feb/legally-speaking/) - [![Healthcare Packaging](https://www.pureglobal.com/assets/press/healthcare-packaging.png)](https://www.healthcarepackaging.com/design-materials/video/22956061/whats-trending-online-december) - [![BioSpectrum Asia](https://www.pureglobal.com/assets/press/biospectrum-asia.png)](https://www.biospectrumasia.com/opinion/120/25272/sustainability-continues-to-gain-significant-attention-in-2025.html) - [![Unite.AI](https://www.pureglobal.com/assets/press/unite-ai.svg)](https://www.unite.ai/dj-fang-co-founder-chief-operating-officer-at-pure-global-interview-series/) - [![Yahoo Finance](https://www.pureglobal.com/assets/press/yahoo-finance.svg)](https://finance.yahoo.com/news/indonesias-3-28-billion-medtech-133900678.html) - [![Morningstar](https://www.pureglobal.com/assets/press/morningstar.svg)](https://www.morningstar.com/news/pr-newswire/20260903ph40070/medical-device-registration-verification-2026-analysis-of-15-national-public-data-files-finds-row-counts-mislead-compliance-and-market-sizing-decisions-driven-by-divergent-file-structures-and-completeness-gaps-pure-global) - [![Benzinga](https://www.pureglobal.com/assets/press/benzinga.png)](https://www.benzinga.com/pressreleases/25/11/n48684930/pure-globals-ai-builder-cuts-medtech-regulatory-submission-time-from-weeks-to-days) Pricing ## **Simple, transparent pricing for global registration**  Accelerate market entry with AI-powered dossier compilation and local representation, all for a market-specific flat annual fee. Pricing varies by country, device class, and portfolio size, and excludes government fees. Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support. Use our Fee Calculator to get your instant estimate. [Get an estimate](https://www.pureglobal.com/services/pricing) ![Pure Global fee calculator preview](https://www.pureglobal.com/assets/owned/8520998ac7--67ab304f89cb5422fdc63bc7__69ef870fd04f69bdc021de81_Pricing-Calculator.jpg) Services ## Medical device regulatory consulting throughout the product lifecycle From medical device regulatory compliance to entering new markets, our comprehensive solutions are designed for every challenge along the way. [See our services](https://www.pureglobal.com/services/market-access) [ ### Global Medical Device Registration Global medical device registration consulting for devices, IVDs, and SaMD across 30+ markets. ](https://www.pureglobal.com/services/global-medical-device-registration)[ ### In-Country Representation In-country representation for medical device, IVD, and SaMD manufacturers, covering local regulatory roles. ](https://www.pureglobal.com/services/in-country-representation)[ ### Quality Management System Medical device quality management system consulting for ISO 13485, FDA QMSR, MDSAP readiness and remediation. ](https://www.pureglobal.com/services/medical-device-qms-consulting)[ ### Supplier Audits Risk-based medical device supplier audits for qualification, surveillance, for-cause review, QMSR and ISO 13485 alignment. ](https://www.pureglobal.com/services/medical-device-supplier-audits)[ ### Medical Device Cybersecurity Secure connected medical devices with FDA, EU MDR, IEC 81001-5-1, testing, and lifecycle support. ](https://www.pureglobal.com/services/medical-device-cybersecurity)[ ### Free Databases & AI Tools Explore open MedTech databases for device registrations, clinical trials, regulations, timelines and government fees. ](https://pureglobal.ai/) [See our services](https://www.pureglobal.com/services/market-access) Who can we help? ## Tailored solutions for medtech entrepreneurs and seasoned professionals Pure Global provides scalable solutions to medical device and in vitro diagnostics manufacturers of all sizes to gain market access. ![Consultants, experts in medical device registration and regulations for Startups](https://www.pureglobal.com/assets/owned/2199add69b--67ab304f89cb5422fdc63bc7__67ab304f89cb5422fdc63d29_audience_1.webp) ### Startups Get agile regulatory guidance and cost-effective solutions with our personalized support to quickly market your innovations. ![Global Scaleups Regulatory Guidance](https://www.pureglobal.com/assets/owned/1d0da7dd83--67ab304f89cb5422fdc63bc7__67ab304f89cb5422fdc63d16_audience_2.webp) ### Global Scaleups Expand globally with our strategic support and partnership developments in emerging medical device and IVD markets. ![Regulatory Guidance for Multinational Enterprises](https://www.pureglobal.com/assets/owned/e4ad22da50--67ab304f89cb5422fdc63bc7__67ab304f89cb5422fdc63d0f_audience_3.webp) ### Multinational Enterprise Use our global regulatory strategies and tech integration, to navigate regulatory complexities and optimize your portfolio. ## Frequently Asked Questions ### What is the advantage of choosing Pure Global as my in-country representative over a commercial distributor? Choosing a third party like Pure Global as your medical device regulatory in-country representative has numerous benefits: **Maintain control to your registration:** In most markets, the in-country representative is the legal name on your registration. If your distributor is your representative, conflicts of interest can arise if you want to change or add distributors in that market. **Fulfill regulatory obligations:** Your representative may have additional regulatory responsibilities to perform on your behalf, depending on the market. Distributors may not be informed about all the duties of an in-country representative or have the resources to perform them. Pure Global has deep experience in the regulatory requirements for all markets where we offer in-country representative services. **Expert regulatory guidance:** Your in-country rep should guide you through the registration process, advise you on the completeness and formatting of your registration dossier, and be a proactive liaison with the local regulatory authority. It is critical to select a regulatory expert who can advocate for your success in your target market. ### How do I stay up to date on global regulatory changes? Medical device compliance requirements are constantly evolving. Whether you are preparing to enter a new market or maintaining existing authorizations, you must be proactive to stay informed of new regulatory developments. Medical device regulatory consultants at Pure Global actively monitor and analyze developments in 30+ markets. Here is how you can stay up-to-date: - [Weekly Regulatory News](https://www.pureglobal.com/resources/news): A round-up of essential medical device regulatory news from around the world, published every week. - [Regulatory Blog](https://www.pureglobal.com/resources/blog): In-depth analysis of developments from our team of regulatory consultants. - [Join our community](https://www.pureglobal.com/resources/community): Get insights from our expert team delivered to your inbox and the latest news from our AI-powered regulatory update tool. ### What is the best stage to seek medical device regulatory consulting services? As soon as possible. Many manufacturers wait until they receive a rejection or information request from a regulatory authority to bring in a regulatory consultant. But regulatory expertise can be invaluable as early as the device design and development stages. We can help you plan for the regulatory implications of your device's intended use and indications for use, establish a holistic QMS that satisfies multiple market requirements, identify device-specific testing needs, and acquire compelling clinical data, if required. Early regulatory planning can save you time and money long term and facilitate your device's entry to the market. ### Can Pure Global support our entry to multiple markets? Pure Global delivers end-to-end, on-the-ground in-country representative and medical device regulatory consulting services in the world's biggest markets from our offices in the US, Europe, the UK, Asia, Latin America, and Australia. Through partnerships with local regulatory consulting firms, we offer extended market access to South Asia, the Middle East, Africa, and beyond. [Canonical page](https://www.pureglobal.com)