RegDesk
7 Case Studies
A RegDesk Case Study
RegDesk worked with a large multinational medical device manufacturer that needed to switch distributors in Taiwan without interrupting supply to local hospitals and pharmacies. The company also wanted to avoid legal risk during the transition and reduce the regulatory burden and product evaluation costs associated with launching the new distributor.
RegDesk delivered a multipoint intelligence report that recommended keeping the old distributor’s exclusivity until its license expired while the manufacturer applied for a new license for the incoming distributor. RegDesk also advised using the manufacturer’s FDA Certificates to Foreign Government and EU Free Sales Certificates to streamline the new application. This approach preserved continuous distribution, avoided legal issues, and allowed the old and new licenses to overlap smoothly, cutting product evaluation costs and timelines by 66 percent.
Large Multinational Medical Device Manufacturer