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Regulatory Affairs Solutions in Mexico

Ensure compliance for Medical Devices and IVDs
Our ServicesFREE consultation

Visit the Office

Marina Nacional 308-6
Col. Anáhuac I Sección
Miguel Hidalgo, CDMX 11320
MEXICO

Need an extra push to navigate the harsh regulatory landscape and bring your innovative products to the Mexican market? Let us help you reach your goals.

Local

Local Regulatory Expertise

At Ciarmi Group, we proudly possess an extensive understanding of the rigorous local regulations in Mexico. With our profound knowledge and expertise in navigating the specific requirements governing the biomedical field, we are well-equipped to provide exceptional support and guidance to our clients.

Efficiency

Efficient Processes

Our streamlined processes deliver regulatory affairs solutions that are efficient and effective. We prioritize optimizing and simplifying the way we handle regulatory matters, ensuring a seamless experience for our valued clients. By utilizing our expertise and industry knowledge, we empower our clients to navigate the complex regulatory landscape with confidence and ease. Experience the difference that our comprehensive regulatory affairs solutions can make for your business.

Success

Successful Case Studies

We take great pride in our exceptional track record of achieving over 900 successful licenses granted for our clients. With unwavering dedication and expertise, we have consistently demonstrated our ability to navigate the complex regulatory landscape, ensuring that our clients receive the necessary approvals to advance their biomedical innovations.

Frequently Asked Questions

How can I get started?

To get started, simply contact our team and we will guide you through the regulatory affairs process for your medical devices and IVDs.

What services do you offer?

We offer a range of regulatory affairs solutions in Mexico, including registration, compliance, consulting, and registration holding services for medical devices and IVDs.

How long does it take?

The time required for regulatory affairs processes can vary depending on the complexity of your medical devices and IVDs. Our team will provide you with an estimated timeline.

What are the costs?

The costs for our regulatory affairs services will depend on the specific requirements of your medical devices and IVDs. Contact us for a personalized quote.

Are you certified?

We proudly comply with COFEPRIS’ requirements and possess extensive expertise in offering regulatory affairs solutions for medical devices and IVDs in Mexico. Our highly knowledgeable team is well-versed in local regulations and requirements, ensuring unparalleled support for our clients.

Do you offer any guarantees?

Yes! For your peace of mind, our payment is split: a deposit upon quote approval, with the final balance due after COFEPRIS document submission. Our support continues until successful registration.

Still have questions?

Health Registration by Equivalence

Learn about the equivalences that the Mexican government accepts for sanitary registrations made abroad.

Trends in Medical Device Manufacturing

Explore the latest trends and innovations in medical device manufacturing

The Importance of Regulatory Compliance

Discover why regulatory compliance is crucial for medical device companies.

Contact us

+52 555 527 8000

+52 557 922 0540

contacto@ciarmi.mx

Marina Nacional 308-6

Col. Anáhuac I Sección
Miguel Hidalgo, CDMX 11320
MEXICO

We are hiring!!!

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