Case Studies
Brand Name Re-Registration with New Logo
Client
Medical Device Manufacturer
Industry
Medical Device
Business Challenge
Implement a new product and logo change across 60 countries
Background
A medical device manufacturer was consolidating its product portfolio, resulting in product and logo changes for 15 products distributed across 60 countries. Although the company name and manufacturing address remained the same, the manufacturer was uncertain about the regulatory registration requirements needed to support these changes globally.
RCA Approach
On a country-by country basis, Regulatory Compliance Associates® Regulatory Compliance Associates® Inc. (RCA) conducted a comprehensive, country-by-country assessment of registration and customs requirements. Where re-registration was necessary, RCA managed the submission process. In many countries, the primary challenge was ensuring the newly labeled products complied with customs regulations. RCA proactively communicated the updated labeling information to local Ministries of Health and the manufacturer’s distributors to facilitate smooth customs clearance.
Results
Thanks to RCA’s strategic approach and regulatory guidance, the manufacturer successfully implemented the product label changes without any interruption to product sales across all markets.
