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If you have no local office in Costa Rica, you must designate a Costa Rica Registration Holder to interact with the Ministry of Health and manage the approval process on your behalf. This is an essential step in registering your medical device for sale in Costa Rica. Your Registration Holder is responsible for submitting all your medical device registration documents to the Ministry of Health, and controls your device registration once regulators grant approval.
Emergo offers regulatory representation for foreign medical device manufacturers looking to commercialize in the Costa Rican market. Our office in San José is staffed by an experienced team of medical device consultants. As your official registration holder, we can perform the following:
Because we have no involvement in sales or distribution of your products, you can establish and change your distribution network without any worries that a distributor (acting as your registration holder) would hold your registration “hostage.” Here are some additional benefits of hiring Emergo:
Emergo provides in-country representation services for clients across North and South America, Europe, the Middle East, Asia and Australia, and has the expertise and resources to fully support your medical device approvals in Costa Rica.