You don’t ask your sales team to offer you regulatory guidance. So why do you rely on your distributor to handle all your regulatory burden? First of all, it’s not so simple to register medical device abroad.
Access to customers sometimes requires partnering with a local distributor. You may feel losing control of your license is worth avoiding the headache of navigating the regulatory hurdles and associated costs.
However, relying solely on the distributor to understand the most current legislations or regulatory requirements is the biggest mistake many small size companies make. You have to remember your distributor’s objective is to sell your products. It is not to invest time with the local regulatory body and keep abreast of the regulatory landscape.
Assuming the distributor will address all the subtle nuances of the regulations for your product is misleading and has caused many companies significant delays, loss of revenue, and market share.
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Distributors are NOT regulatory experts. Relying on them for your product compliance is RISKY!
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