Share Our Information
Re-Registration with New Logo and Brand Name
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.
We were in jeopardy of losing confidence from our export partners; this remedy saved our reputation and prevented product backorders.
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, so RCA communicated the new label to the local Ministries of Health and the distributors in each country.
Results
The manufacturer was able to change the product label and not interrupt any product sales.
