Background

A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries. Since the company name and the manufacturing address remained unchanged, the manufacturer was unclear on the registration requirements. A brand name re-registration and logo update needed to be updated and submitted regionally. 

Solution

On a country-by country basis, Regulatory Compliance Associates^® Inc. developed the registration and customs requirements and executed the go-forward plan. In some countries, re-registration was required and RCA handled the submission.

In many countries, the bigger hurdle was ensuring the newly labeled product would pass customs requirements. RCA communicated the new brand name re-registration to the local Ministries of Health and the labeling change to distributors in each country.

 

Results

The manufacturer was able to change the product label and not interrupt any product sales. The brand name re-registration was approved and regulatory action has not been needed since the project ended. 

 

About RCA

Regulatory Compliance Associates^® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
  • Regional offices in Florida, Colorado and Europe
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

To begin the RCA^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.