Emergo assists medical device companies with the PMDA medical device registration and approval process in Japan including Todokede submissions, Ninsho certification and Shonin approvals.
Need a Korean license holder for your medical devices? You can appoint us as your medical device representative with our Korea License Holder (KLH) services.
We can prepare your team with on-site or remote In Vitro Diagnostic Medical Devices Regulation (EU IVDR) training provided by our experienced regulatory consultants.
We can help you register your medical device for sale in Costa Rica and obtain approval for your medical device from the Costa Rican Ministry of Health.
We can help medical device manufacturers comply with regulatory approval standards in Singapore under the Health Sciences Authority (HSA) for market access.