Indonesia Device Registration Not So Straightforward

Unlike the other Asian countries, in Indonesia, an independent, third party entity in-country cannot register foreign devices. According to Indonesian law, devices can be registered via the foreign company’s Indonesian distributor or the foreign company’s subsidiary operation in Indonesia. To get around such regulations and keep a foreign company’s registrations “independent” from their distributor, some foreign companies have hired one distributor to import and hold its registrations (a “dummy” distributor), but then used a second distributor (sub-distributor to importing distributor) to sell the products in-country. In this scenario, the money flow goes from the second distributor to the first “dummy” distributor to the overseas medical device company.

The benefit of this situation is that the first distributor holding your registration is not the actual sales agent, so in a sense this first “dummy” distributor can hold your registration “independent” of the selling distributor. The disadvantage in this scenario is the first “dummy” distributor normally charges a high fee for providing this service.