Arazy Group
Arazy Group Consultants Inc.
Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. They offer AI-powered solutions and expert guidance to accelerate market access in over 140 countries.
Arazy Group is a premier consulting firm with over 30 years of experience, dedicated to streamlining regulatory affairs and product registration for medical devices and IVDs. Their mission is to facilitate the global availability of innovative medical technologies. Leveraging cutting-edge AI-powered technology and deep regulatory expertise, Arazy Group provides solutions that expedite device registration in over 140 countries. Their platform offers customized submission files, automated compliance workflows, and real-time process management, significantly reducing time-to-market and associated risks. They offer comprehensive services including global authorized representative and license holder services, ensuring compliance and market access across diverse regions. Arazy Group's commitment to client success is demonstrated through personalized support and a focus on building long-term partnerships, making them a trusted advisor for companies ranging from startups to multinational corporations.
About
**Who they are**
Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. With over 30 years of experience, they leverage AI-powered solutions and expert guidance to accelerate market access.
**Expertise & scope**
* Specializes in regulatory affairs and product registration for medical devices and IVD products.
* Offers AI-powered regulatory technology products: LICENSALE® (Global MedTech Registration System) and REGISLATE® (Global MedTech Registration Management Software).
* Provides services in over 140 countries worldwide.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Expertise in Swiss medical device regulations, including classification aligned with the EU model (Classes I, IIa, IIb, III) and IVD devices.
* Understands that medical devices can remain on the Swiss market as long as their CE Mark is valid.
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 MedTech product registration activities worldwide.
* Global presence in more than 100 countries worldwide, including the EU.
Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. With over 30 years of experience, they leverage AI-powered solutions and expert guidance to accelerate market access.
**Expertise & scope**
* Specializes in regulatory affairs and product registration for medical devices and IVD products.
* Offers AI-powered regulatory technology products: LICENSALE® (Global MedTech Registration System) and REGISLATE® (Global MedTech Registration Management Software).
* Provides services in over 140 countries worldwide.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Expertise in Swiss medical device regulations, including classification aligned with the EU model (Classes I, IIa, IIb, III) and IVD devices.
* Understands that medical devices can remain on the Swiss market as long as their CE Mark is valid.
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 MedTech product registration activities worldwide.
* Global presence in more than 100 countries worldwide, including the EU.
Additional information
Arazy Group's approach combines technology with expert guidance to streamline market access for medical devices and IVDs. Their proprietary tools, LICENSALE® and REGISLATE®, are designed to manage registration processes efficiently. For Switzerland specifically, they note that medical device licensing is overseen by Swissmedic and that classification follows the EU model. They also highlight that license validity in Switzerland is tied to the CE Mark, typically lasting five years. Companies can leverage Arazy Group's services to navigate these specific Swiss requirements and maintain market presence.
Key Highlights
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30 years of MedTech regulatory experience.
Source
“With over 30 years of experience, our team has helped thousands of MedTech companies successfully navigate the complex registration processes”
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Offers services in 140+ countries worldwide.
Source
“We offer services available in 140+ countries worldwide, enabling companies a significant global advantage”
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Provides License holder and Authorized Representative services in over 100 markets.
Source
“We also offer License holder and Authorized Representative services in more than 100 markets”
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Innovators of LICENSALE® and REGISLATE® regulatory technology.
Source
“The Arazy Group is the innovator behind the most effective and widely used MedTech regulatory technology products, LICENSALE® – Global MedTech Registration System and REGISLATE® – Global MedTech Registration Management Software (RMS).”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking to register medical devices and IVDs globally.
- Firms needing a Swiss Authorized Representative.
- Businesses looking to leverage AI-powered regulatory solutions.
How engagement typically works
- Consultative approach to tailored compliance solutions.
- Partnership for market access acceleration.
Typical deliverables
- Global medical device and IVD registration.
- Swiss Authorized Representative services.
- Regulatory strategy and guidance.
- License holder services.
Good to know
- Best when requiring specialized regulatory expertise for complex markets like Switzerland.
HQ:
Vancouver, Canada
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Onboarding involves understanding client's specific requirements to provide tailored solutions for market access.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (Medical Devices); Same as EU IVD (IVD Devices)
Supports MDR
Implied through EU classification alignment
Supports IVDR
Implied through EU classification alignment
Labeling Support
Implied through offering services in Switzerland
Swiss Local Contact
Implied through offering services in Switzerland
Vigilance Contact Support
Implied through Authorized Representative services
Can Be Named On Label
Implied through Authorized Representative services
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