Successful Case

Pure Global earns 2 New Brazilian certificates

Pure Global Secures Two Class II Medical Device Certificates in Brazil, Bolstering International Expansion Capabilities.

Published on:
March 1, 2024

We're proud to announce that Pure Global has successfully obtained two certificates from Brazil for Class II products. These certifications are for interventional catheter consumables companies for medical device MDs in Suzhou and Shenzhen, respectively.

Our Brazilian self-operated companies boast a growing portfolio of certificates and satisfied customer groups. With a highly experienced technical team in Brazil, we maintain excellent communication channels with #ANVISA and offer years of rich registration expertise. This enables us to efficiently meet our customers' submission and certification requirements, ensuring a smooth process.

Pure Global is your professional registration consulting partner, guiding companies through international expansion with detailed expertise, efficient execution, and firsthand resources. Our success in Brazil underscores our ability to provide comprehensive consulting services and secure certifications for our clients.

At Pure Brazil, our commitment to service and professionalism shines through. As an independent third-party certificate holder, we prioritize customer needs, employing a dual PM work model to ensure timely responses. Our expert regulatory consulting team and self-operated companies maintain strong relationships with local representatives in Brazil, providing manufacturers with accurate and timely information on local regulations and authorities' feedback.

Trust Pure Global and Pure Brazil for seamless market access and regulatory compliance solutions!

Subscribe to newsletter
Subscribe to receive the latest blog posts to your inbox every week.
By subscribing, you agree to our Terms and Conditions.
Thank you for subscribing!
Oops! Something went wrong while submitting the form.
Read more

Latest News

Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.

Regulatory Update
December 18, 2024

Closing out 2024, we bring you substantial medical device updates from Europe, Brazil, and beyond, including the launch of public consultation on EU device regulations, an updated roadmap for regulatory implementations in the UK, and several new and updated resolutions in Brazil.

Regulatory Update
December 11, 2024

Early December 2024 regulatory news brings updates from Europe, US, Brazil, China, and Japan, including new FDA guidance on change controls for AI-enabled devices and an innovation-focused approach to clinical research regulations in Brazil.

An extensive round-up of medical device regulatory news from November 2024 includes new and updated guidance documents, Q&As, and directives from Europe and the US, including the new EU Product Liability Directive for AI and Smart Products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.

Contact us
Request information

Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Our closest representative will get back to you within 24 hours.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Latest Blog Content

Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.

Pure Global 2024 Year in Review
Blog Article
Pure Global 2024 Year in Review

As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.

Risk increases compliance chalenges under IVDR
Blog Article
What are the challenges under IVDR?

IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.

Blog Article
EU Parliament Revises MDR and IVDR

On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.

Blog Article
Language Challenges in MedTech Going Global and Our Solution

Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.