Medical Device Registration
What’s Standing Between Your Company and the World’s Largest Markets?
To reach new markets, your company needs a reliable partner to guide you through the shortest path to registering your medical devices.
At Sobel, we offer medical device registration expertise across the main regulated markets worldwide — guiding your company from local submissions to international export approvals.
The Challenge of Global Medical Device Registration.
Expanding into new markets can be complex for any medical device manufacturer. Each country has its own regulatory system, submission formats, and timelines — from the FDA in the United States to Anvisa in Brazil or NMPA in China.
Without a well-defined medical device regulatory strategy, companies often face delays, document rejections, or even loss of market opportunities.
Navigating these regulations alone can be overwhelming, which is why partnering with a trusted regulatory expert becomes essential to achieve compliance and accelerate global growth.
- United States
- Canada
- Brazil
- Europe
Are you sure you’re reaching the full potential of your market?
With the right medical device registration strategy, your product can go beyond borders — reaching new regions, patients, and opportunities worldwide. Sobel helps you turn regulatory barriers into global expansion.
Global Market Access:
Launch your product in the most regulated markets with a single, coordinated strategy.
Regulatory Confidence:
Eliminate uncertainty with a clear medical device regulatory strategy designed to fit your product class.
Seamless
Validation:
Ensure compliance with local standards through expert medical device validation services.
Expert
Support:
Work with experts who guides you from medical device development from prototype to regulatory approval.
Global Registration Is Complex.
But You Don’t Have to Face It Alone.
Medical device registration is complex, but you don’t have to face it by yourself. Our regulatory experts guide you through every step — from documentation to market approval — anywhere in the world.
Forget the myths. Focus on what works:
"My company is small or mid-sized. Is this service really for me?"
Absolutely. We support startups, growing businesses, and global manufacturers alike. Whether you’re registering your first product or managing a complex portfolio, Sobel adapts the medical device registration process to your scale and strategy.
“It always takes too long. And I don’t have time to waste.”
The right medical device regulatory strategy can dramatically shorten your approval timeline. Our proactive approach and global coordination help you avoid rework, delays, and unnecessary costs — so you can reach the market faster.
“I already have a local consultant. Do I really need global support?”
Local expertise is valuable, but a global regulatory expert ensures your documentation and compliance strategy stay consistent across all jurisdictions — preventing gaps, duplication, or conflicting submissions.
“I already have CE marking — do I still need registration?”
Yes. Each market requires its own approval. Even with CE marking, you’ll need local medical device registration such as Anvisa medical device or FDA medical device clearance.
How much easier could your regulatory journey be with Sobel by your side?
- We handle medical device notification and registration in your origin country or any target market.
- Medical device development from prototype to regulatory approval: Full service! We support you through all phases.
- Craft your medical device regulatory strategy customized per country, class, and risk level.
- Provide medical device validation services (e.g. testing, verification, clinical/biocompatibility etc.).
- Act as your local partner and agent in regions where needed (U.S., EU, Brazil, China, etc.).
- Support with maintenance, renewals, changes, audits and post-market compliance.
Don’t Let Regulatory Delays
Hold You Back
While competitors wait for approvals, you could already be entering new markets. Sobel helps you fast-track your medical device registration with a proven regulatory strategy that saves time and ensures global compliance.
Frequently Asked Question
What does medical device registration mean in different countries?
It means obtaining regulatory registration or notification, so your device can legally be marketed and sold locally.
Do I still need CE marking?
Yes. CE marking remains essential for European market, but there are countries that require both CE and local registration.
Can you register for China?
Yes — we deal with NMPA China (formerly CFDA) registration services and local agent support.
How long does it take?
It depends on device class and jurisdiction, but we map a realistic timeline in your medical device regulatory strategy.
What if my design is not yet finalized?
We work from medical device development from prototype to regulatory approval, so we can start early and guide you.
Do you provide validation/testing services?
Yes — our medical device validation services are part of our offering or via trusted partners, with services like CEP/CER, BEP/BER and more!
About Us
Sobel Consultancy is a global regulatory consultancy specialized in medical devices.
We transform regulatory challenges into compliance success.
Why trust us:
- Years of experience handling registrations in U.S., EU, Latin America, China
- Team of regulatory experts with hands-on dossier preparation
- Proven track record in medical device registration and notification across many markets
- Local partners and agents to ensure seamless submissions
Our mission is to enable medical device innovators to focus on design and impact, while we handle the regulatory pathway!
Stop delaying your market launch. Let Sobel manage your medical device registration globally.
Contact Us
We would love to speak with you.
Feel free to reach out using the below details.
