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Clear and Compliant
Regulatory Guidance for Veterinary Medical Devices
Veterinary device regulations don’t have to be confusing. Let us guide you through the process.
Expert Support
How can we help?
Need to know more about your device registration or classification? Build your regulatory strategy quickly, effectively, and in line with current legislation.
Informed Decisions, Faster Approvals
1. Regulatory Guidance
Regulatory guidance supports your understanding of veterinary device requirements, connects you with key resources, and makes communication with authorities easier.
Overview of current regulatory requirements
Stay informed about the latest regulatory requirements across different jurisdictions (EU, USA, Canada, Japan, etc). AnimalDevices will help you identify key regulatory frameworks and understand their impact on product registration, manufacturing, and post-market obligations.
Access to databases of approved products
Approved veterinary devices can offer helpful examples — but national databases of approved products are often hard to find or accessible only on request. AnimalDevices can connect you to relevant databases and help you identify the most relevant products.
Contacts for regulatory authorities
In markets like Japan, complex regulations and language barriers can make direct communication with regulators challenging. AnimalDevices helps you establish effective contact with relevant authorities and connect you with local industry groups where needed.
Smart Planning
2. Consulting
Personalized regulatory consulting will help you to classify your product, plan ahead, and bring it to market with confidence.
Device classification
Veterinary medical devices are usually on the border between medicinal products, biocides, feeds, and general consumer products. Accurate classification is critical, as it affects the entire regulatory process. AnimalDevices provides solid data and analysis to support your decisions.
Regulatory strategy
Identify the most effective and compliant route to bring your product to market. Whether it’s veterinary-specific registration or leveraging human product approvals for dual use, AnimalDevices helps you define the best path forward.
Project planning
Proactive planning helps you avoid delays. AnimalDevices assists in identifying regulatory risks early and developing mitigation strategies to keep your project on track.
Where Strategy Meets Action
3. Registration & Insight
Expert services extend beyond guidance to support your registration process, strategic positioning, and market awareness.
Device registration
Get support with preparing and submitting regulatory applications tailored to national requirements in selected countries. AnimalDevices also facilitates effective communication with the relevant authorities to ensure a smooth registration process.
Competitor analysis
Know your competitors and learn from them. AnimalDevices help you identify both direct and indirect competitors, analyze their claims, and product positioning — all to support your strategic decisions.
Custom Reports & Regulatory Monitoring
Interested in current regulatory trends? Want to explore the regulation of veterinary devices in a particular country outside the EU? AnimalDevices offers reports and regulatory updates tailored to your needs and markets of interest.
Steps of Our Cooperation
How it works?
Step 1
Contact us
Let’s determine how we can support your veterinary medical device project.
Step 2
Non-Disclosure Agreement
We sign an NDA to ensure your confidential information is fully protected.
Step 3
Project Definition
We define goals, deliverables, and timelines tailored to your regulatory needs.
Step 4
Delivery by Defined Milestones
You receive clear, timely results at each project stage.
Regulations Worldwide
Overview of Veterinary Medical Device Regulations
Medical devices
Comparison of veterinary device regulation frameworks — including pre-market and post-market requirements, and responsible authorities.
Country | Dedicated legislation | Pre-market Requirements | Post-market Requirements | Manufacturing approval/facility registration | Competent authority | Note |
EU | NO | NO | NO | NO | NO | EU level: Only general requirements (safety, liability, and requirements on devices using electricity; chemical and biological safety) National level: Dedicated regulation in several member states (e.g. Czechia, Germany, Portugal) |
Canada | YES | NO | NO | NO | Veterinary Drugs Directorate (Health Canada) | |
USA | YES | NO* | NO* | NO | Center for Veterinary Medicine (Food and Drug Administration) | *) Specific requirements apply only to devices emitting radiation (e.g. MRI or X-ray) that fall under the authority of Center for Devices and Radiological Health (CDRH). |
Japan | YES | YES | YES | YES | National Veterinary Assay Laboratory (Ministry of Agriculture, Forestry and Fisheries) | Devices are divided into three/four risk classes with different requirements. |
In vitro diagnostic medical devices
Overview of veterinary IVD regulations across key countries, including approval processes and competent authorities.
Country | Dedicated regulation | Pre-market Requirements | Post-market Requirements | Manufacturing approval/facility registration | Competent authority | Note |
EU | NO | NO | NO | NO | NO | EU level: only general requirements (safety, liability, and requirements on devices using electricity; chemical and biogical safety) National level: dedicated regulation in some countries (e.g. Germany, Netherlands, Poland) |
Canada | YES* | YES | YES | YES | Canadian Center for Veterinary Biologics (Canadian Food Inspection Agency) | *) Only diagnostic kits for the detection of infectious diseases. |
USA | YES* | YES | YES | YES | Center for Veterinary Biologics (USDA–APHIS) | *) Only diagnostic kits for the detection of infectious diseases. |
Japan | YES | YES | YES | YES | National Veterinary Assay Laboratory (Ministry of Agriculture, Forestry and Fisheries) | Devices are divided into two risk classes with different requirements. |
Klient’s Words
References
The research and application process is complex and I will be happy to help you with it.
Who’ll Guide You
About Us
Hana Potockova, Ph.D.
AnimalDevices, Ltd. was founded by Hana Potockova, Ph.D., a regulatory expert with over 10 years of experience in human and veterinary medical devices and pharmaceuticals.
Hana holds a PhD in Pharmacy, focusing on Drug Safety and Quality. Her doctoral research explored the regulation of veterinary medical devices, inspired by challenges the company she worked with at the time faced. These products often fall into regulatory grey areas, and AnimalDevices was created to bring clarity and practical guidance to this field.
Thanks to this broad experience, we understand the complexities of the regulatory environment — including borderline products like biocides or cosmetics. We look forward to supporting your project with tailored, practical guidance.
What can you expect?
- Cross-sector experience
- Practical approach
- Diligence and precision