Achieving a Smooth Distributor Transition: How RegDesk Preserved Market Share and Business Continuity for an International Device Manufacturer
Situation
A multinational medical device manufacturer with a significant market share in Taiwan wanted to change its current distributor to collaborate with a new distributor who would better represent its brand and products. Furthermore, the company wanted to do this while causing minimal disruption to the distribution of its products to local hospitals and pharmacies. Several unanswered questions were standing in the way of this transition.
Objectives
- Ensure that the supply and distribution of products are uninterrupted during the transition
- Obtain reliable and up-to-date answers to questions related to distributor transition in Taiwan
- Mitigate the legal risks associated with changing distributors
- Reduce the regulatory burden and product evaluation costs
Why They Chose RegDesk
RegDesk provided a unique, multipoint intelligence report that identified an efficient strategy to accommodate the client’s top priority of uninterrupted supply and distribution of products. The report suggested that the old distributor retains exclusivity and rights to sell the manufacturer’s products until its license expires while the manufacturer applies for a new license for the new distributor. It also suggested that the application process for the new license use the manufacturer’s Certificates to Foreign Government (CFG) from the US FDA and Free Sales Certificates (FSC) from the EU to reduce regulatory burden and product evaluation costs.
Results
The continuation of the exclusivity period for the old distributor until the expiration of the existing license staved off any legal risks associated with changing distributors. Simultaneously, starting a new license application ensured that the expiration of the old license would seamlessly blend into the validity period of the new one. Furthermore, using the manufacturer’s CFGs and FSCs reduced the company’s regulatory burden. Product evaluation costs and timelines were cut by 66 percent.
Summary of Challenges
- Possible disruption of distribution of products to local hospitals and pharmacies
- Legal risks associated with changing distributors
- Regulatory burden and product evaluation costs
Summary of Results
- Continuous distribution of products was achieved during the transition process
- Any legal risks associated with changing distributors were avoided
- The expiration of the old license seamlessly blended into the validity period of the new one, resulting in a smooth transition
- Company’s regulatory burden was reduced by the use of the manufacturer’s CFGs and FSCs
- Product evaluation costs and timelines were cut by 66%
