Global Medical Device & IVD Registration Services – UK, EU, India & International Markets
Expanding into international markets requires compliance with a range of regulatory frameworks beyond the UK and EU. At MedTech Consultancy, we help medical device, IVD, and digital health manufacturers navigate global registration requirements to achieve safe and compliant market entry in key territories worldwide.
Whether you’re targeting the USA, Canada, India, Middle East, Asia, or other regions, our global registration services guide you through submission requirements, local regulations, and post-market obligations.
What Is Global Registration?
Global registration refers to the process of obtaining regulatory approval or clearance to market medical devices and IVDs in jurisdictions outside the UK and EU – each of which has its own regulatory expectations, submission requirements, and timelines.
This can include: Government agency registrations, Local authorised representative requirements, Technical file or dossier submissions, Quality system recognition. Successfully navigating this landscape requires up-to-date knowledge of international regulatory practices and practical experience across regions.
Markets We Support
We assist with market entry and registration in key global territories:
🇺🇸 United States (FDA)
- 510(k), De Novo, PMA planning and submissions
- Regulatory strategy aligned with FDA requirements
🇨🇦 Canada (Health Canada)
- Licensing and Medical Device Establishment Licences (MDEL)
- Regulatory compliance for Canadian market access
🇦🇺 Australia (TGA)
- ARTG registration and compliance under the TGA framework
🇯🇵 Japan (PMDA)
- Device registration strategies and submission support
🇮🇳 India (CDSCO / IVD & Medical Device Registration)
- Device registration under Central Drugs Standard Control Organization (CDSCO)
- Support for Indian IVD and medical device approval process
- Assistance with import licenses, technical documentation, and local authorised representative requirements
🇦🇪 Middle East
- Local regulatory requirements, including UAE and Saudi market strategies
🌏 Other Emerging Markets
ASEAN, Latin America, South Africa, and beyond
Note: Market requirements vary; we tailor our strategy to each jurisdiction’s regulations.
Our Global Registration Services
We provide comprehensive support for global regulatory registration, including:
Regulatory Pathway Planning
We analyse your target markets and define the most efficient registration strategy, aligned with your business goals and timelines.
Submission Dossier Preparation
We prepare high-quality regulatory submissions, including:
- Technical documentation
- Local language requirements where applicable
- Supporting clinical and performance evidence
Local Representative Support
We assist with authorised representative appointments (required in some regions like India, EU, and Middle East).
Communication With Authorities
We manage communication with regulatory agencies throughout the submission and review process.
Post-Market Obligations
We support compliance with ongoing requirements such as registration renewals, vigilance reporting, and local QMS expectations.
Why Global Registration Matters
Global registration is critical to:
✔ Legally placing your products in international markets
✔ Expanding revenue opportunities
✔ Building long-term commercial strategy
✔ Supporting global post-market surveillance
Navigating multiple regulatory frameworks without specialised expertise can lead to:
❌ Submission delays
❌ Non-compliance issues
❌ Increased costs and resource strain
Who Needs Our Global Registration Services?
Our services are designed for:
✔ Medical device and IVD manufacturers
✔ Start-ups targeting new market entry
✔ Companies expanding beyond UK/EU markets
✔ Regulatory, QA, and product teams managing multi-jurisdiction compliance
How We Work
1. Initial Consultation
We assess your device portfolio and target markets to determine priorities and regulatory requirements.
2. Regulatory Requirements Analysis
We map out global jurisdiction requirements — including documentation, timelines, and pathways.
3. Strategy & Submission Planning
We develop a tailored plan and submission roadmap for each market.
4. Dossier Preparation
We compile and optimise your documentation for regulatory review and acceptance.
5. Submission & Follow-Up
We support submissions and liaise with authorities on your behalf.
Why Choose MedTech Consultancy
🔹 Cross-jurisdiction regulatory expertise
🔹 Structured, compliant approach to multi-market submissions
🔹 Practical experience with FDA, TGA, Health Canada, CDSCO (India), and other agencies
🔹 End-to-end support from planning to post-market obligations