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