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Clear and Compliant
Regulatory Guidance for Veterinary Medical Devices
Veterinary device regulations don’t have to be confusing. Let me guide you through the process.
Advanced Support
Services
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). I’ll help you navigate 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. I can connect you to relevant databases and help you identify most relevant products.
Contacts for regulatory authorities
In markets like Japan, complex regulations and language barriers can make direct communication with regulators challenging. I help 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. I provide 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, I’ll help you define the best path forward.
Project planning
Proactive planning helps you avoid delays. I assist in identifying regulatory risks early and developing mitigation strategies to keep your project on track.
Beyond Basics
3. Other Services
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. I also facilitate effective communication with the relevant authorities to ensure a smooth registration process.
Competitor analysis
Know your competitors and learn from them. I 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? I offer reports and regulatory updates tailored to your needs and markets of interest.
Steps of Our Cooperation
How it works?
Step 1
Contact me
Let’s determine how I can support your 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) National level: Dedicated regulation in several member states (e.g. Belgium, Czechia, Germany) |
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) 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 me
Hana Potockova, Ph.D.
I hold a PhD in Pharmacy with a focus on Drug Safety and Quality. My doctoral research explored the regulation of veterinary medical devices — a topic I chose based on challenges faced by the company I was working with at the time. These products often fall into regulatory grey areas, and my aim was to bring more clarity and practical guidance.
For over 10 years, I’ve used my expertise to support companies producing both human and veterinary medical products and pharmaceuticals. I’ve held roles such as Regulatory Specialist, and Project Manager, and I’ve contributed to strategic decisions across product development, registration, and market access.
Thanks to this broad experience, I understand the complexities of the regulatory environment — including borderline products like biocides or cosmetics. I look forward to supporting your project with tailored, practical guidance.
