In Indonesia, imported pharmaceuticals and medical devices must be registered with Indonesia’s National Agency of Drug and Food Control (NA-DFC). In order to do so, the foreign medical product manufacturer must have its own subsidiary, manufacturing facility, or authorized distributor act as its local agent. Foreign manufacturers cannot directly apply for registration of their products on their own without their own office or a distributor in Indonesia. Thus, independent third parties cannot act as the legal agent in Indonesia as they can in the other Asian countries. However, in some instances, “dummy” distributors can be used to operate like an independent third party.
Pacific Bridge Medical can work via a third party distributor in Indonesia to act as your local in-country representative and assist with registration of your medical products. This third party distributor will meet the legal regulatory requirements, but will not sell your products to end-users. Rather, the third party distributor will import your medical products into Indonesia and re-sell your products to other Indonesian distributors, who will then sell to hospitals, clinics, etc. Employing a third party distributor as your license holder will allow your company to switch distributors easily. The third party representative can also liaise with the NA-DFC, handle all product recalls, and inform your company of any Indonesian regulatory changes.
To find out more about in-country representatives or Indonesian medical regulations, please contact us today and speak with one of our expert consultants about your company’s products.
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