Medical Device Registration Services for Global Markets

Get expert support in registering your medical devices across regulated and emerging markets. Artixio simplifies global submissions and helps you meet compliance with region-specific medical device regulations.

Services We Offer

Solution by Countries

Our Industries

End-to-End Medical Device Registration Support by Artixio

Registering a medical device involves more than just submitting documents — it requires a indepth understanding of region-specific classifications, evolving regulatory requirements, and technical documentation formats. Artixio offers tailored support at every stage to help manufacturers get market access efficiently and compliantly.

Pre-Registration → Regulatory Submission & Approval → Post-Market Compliance

Pre-Registration

Registration

Post-Registration

Regulatory Authority Coordination

Artixio works directly with national competent authorities, notified bodies, and regulatory agencies in both high-regulation (e.g., FDA, EU, CDSCO) and emerging markets. Our localized regulatory intelligence helps fast-track submissions and avoid common delays.

Trusted Partner for Medical Device Market Entry

Global reach with local regulatory insights
Experience with Class I to III & IVDs
Support for EU MDR, US FDA, ASEAN, and more
In-house experts with 15–30+ years’ experience
Hands-on support from submission to post-market
Flexible models: project-based or dedicated FTE

FAQs

1. How do I know what classification my device falls under?

Device classification depends on the intended use, risk level, and country-specific rules. Artixio helps determine the correct class during the pre-registration phase to avoid delays.

2. Can you help with EU MDR and US FDA registrations simultaneously?

Yes. Our teams handle multi-region strategies and prepare region-specific dossiers (like 510(k) or EU MDR technical files) in parallel to speed up global approvals.

3. What if my device is already approved in one market?

We assess existing approvals and identify what additional documentation is needed for other markets, reducing duplication and cost in global expansion.

4. Do you assist with local representation in countries where it's mandatory?

Yes. Artixio provides or coordinates with authorized representatives and local agents in regions like the EU, Japan, and LATAM where in-country presence is required.