Medical devices regulatory services, medical device registration, IVD classification

Regulatory Offerings

For nearly a decade we have been setting the industry standards in assisting Medical Device and IVD companies worldwide for end-to-end Regulatory needs and product registration.

COUNTRY-SPECIFIC SERVICES

USA

510(k) Premarket Notification
513(g) Submission
US Agent

Canada

Medical Device Establishment Listing (MDEL)
MDSAP Compliance
Medical Device Listing (MDL)

Mexico

Device Registration
Sanitary Responsible Person (SRP)
Post Market Surveillance(PMS)

Brazil

Device Notifiication
Cadastro and Registro
BGMP Compliance

France

European Medical Device Classification
EU Authorized Representative (EC REP)

European Union

EU - ISO 13485:2016 compliance
CE Marking
EU MDR
IVDR Transition

Italy

ISO 14971 Risk Management Consultation
EU Medical Device Registration

Netherlands

In Vitro Diagnostic Regulation (IVDR)
Medical Devices Regulation (MDR)

China

Local Representation
Post Market Surveillance
Medical Device Registration

India

Indian Authorized Agent
Import License
Device Listing
Manufacturing License

Indonesia

Local Representation
Post Market Surveillance
Medical Device Registration

Japan

D-MAH / MAH Services
FMR Registration
Device Registration

Malaysia

CAB Assessment
MDA approval
Local Representation

South Korea

Local Representation
Post Market Surveillance
Medical Device Registration

Srilanka

Device Registration
Sample and commercial Import License
Local Representation

Taiwan

Local Representation
Post Market Surveillance
Medical Device Registration

Thailand

Local Representation
Post Market Surveillance
Medical Device Registration

UAE

Local Representation
Post Market Surveillance
Medical Device Registration

Vietnam

Local Representation
Post Market Surveillance
Medical Device Registration

Australia

Australian Sponsor Services
Conformity Assessment services
ARTG Listing

Saudi Arabia

Medical Device National Registry (MDNR) Listing
Medical Device Marketing Authorization (MDMA)
Saudi Arabia Authorized Representation

Worldwide comprehensive services

Proven Expertise

Freyr is uniquely positioned to deploy best vertical/divisional in-house experts to provide the best Regulatory approach, specifically for combination product portfolio companies. The customized nature of Freyr services is synchronized keeping in mind our customers’ growth strategy and product portfolio.

Freyr offers you a robust combination of technology and Regulatory expertise to ensure product continuity, label compliance, and data quality. We are committed to partnering with companies by providing strategic guidance as they develop, advance and innovate devices.

1250+
Global Customers
and Growing
1800+
Global
Regulatory Experts
120+
Countries Constitute
our Regional Medical
Device Regulatory Services Portfolio
295+
Medical Device
Companies Have
Chosen Us as Their
Strategic Partner
4
Forbes Global Top 5
Medical Device
Companies Have
Chosen Us as Their
Strategic Partner

Insights

Stay ahead of the curve with the latest updates on Medical Device Regulation, Health Authority Mandates, market trends and developments.

Blogs

Top 5 Obstacles Encountered by Manufacturers in Medical Writing
Read More
Case studies

Regulatory Services for Medical Device Registration and LR Support in Thailand
Read More
mandates

CDSCO, India Has Included 8 New Device Types to The List of Regulated Medical Devices.
Read More

What our Clients say

Director, Regulatory Affairs,

US based leading precision medicine company

We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.

Director, Regulatory Affairs,

US based leading precision medicine company

Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.

Regulatory Affairs Officer

A Global Industry Leader in Medical Device Design and Manufacturing

You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!

Associate, Regulatory Affairs Team II,

Clinical & Regulatory Affairs Center,
A Korean Chemical Company

Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.

Manager, Regulatory Affairs

A Spanish Medical Devices Manufacturer

Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!

Director, Regulatory Affairs

US based top Sterilization company

The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?

Looking for a Regulatory Partner?

Freyr - a Leading Medical Devices Consultancy Firm with Offering Services in 120+ Countries and 1100+ Global Clients

One-Stop Regulatory Specialist

for GLOBAL MARKET Access in 120+ COUNTRIES

Regulatory Offerings

COUNTRY-SPECIFIC SERVICES

Worldwide comprehensive services

Proven Expertise

Insights

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What our Clients say

Director, Regulatory Affairs,

Director, Regulatory Affairs,

Regulatory Affairs Officer

Associate, Regulatory Affairs Team II,

Manager, Regulatory Affairs

Director, Regulatory Affairs

Let’s connect

We’re here to help and answer any question you might have. We look forward to hearing from you.

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Looking for
a Regulatory Partner?

Freyr - a Leading Medical Devices Consultancy Firm
with Offering Services in 120+ Countries and 1100+ Global Clients

One-Stop
Regulatory Specialist

We’re here to help and answer any question you might have.
We look forward to hearing from you.