The Situation
Manufacturers wishes to gain market entry quickly and smoothly
Distributors wishes to gain sales more quickly
The Problem
Regulatory and import processes in various countries are often lengthy, complicated, and unclear. More about this global issue.
Potential problems are not discussed upfront and the approval process lacks transparency.
More Problems!
When the business partnership turns sour, supplying product may be a problem as the product license and import rights are held by the local distributor
License transfer processes are very complicated, and can take a very long time. Competitor products may take your market share, or worse, the people are denied the device and thus cannot gain access to healthcare
The needs
Strong professional expertise in regulatory and import strategies and clearance execution
Reliable ways to separate legal liabilities in licenses from in-country sales to maintain supply continuity
Our Solutions
We have expert in-country regulatory and trade compliance team members that would physically execute the necessary processes. More about our capabilities.
We have GREAT connections with various regulatory bodies in the countries that we have presence, to smoothen out the clearance processes
A clear description of the regulatory/import processes, and risk mitigation planning prior to contract signing. Transparency every step of the way
There’s more!
Access-2-Healthcare physically owns company entities that are legally able to maintain your product/import license for you.
Access-2-Healthcare uG (Germany) is a licensed European Union Authorised Representative (EU AR). Fully compliant to MDD 93/42 and EU MDR/IVDR
Your Results
We ensure you gain market entry in the smoothly and predictably, with clear transparency in processes and costs.
With your licenses safety held by Access-2-Healthcare, supply disruption will be a thing of the past. Distributor management have never been easier.
email our Regulatory Team
