Costa Rica Enhances Medical Device Registration Process for Foreign Manufacturers

Published June 28, 2017/Costa Rica

Introduction

Costa Rica medical device regulators are preparing a system to facilitate online registration of medical devices in a move to drive up foreign manufacturers’ interest in the Central American market.

Training and Resources

The Costa Rican Ministry of Health has published training materials for digital medical device registration and is conducting training sessions - https://registrelo.go.cr/cfmx/ms/anuncios/anuncio.cfm (link in Spanish) to explain the new process.

System Overview

The new system will allow registrants to send application materials for Ministry of Health review from any location at any time.

Costa Rica Quick Facts

Regulatory Agency	SUTEL (Superintendencia de Telecomunicaciones)
Certification Type	Mandatory
License Validity	Indefinite
Application Language	Spanish
Legal License Holder	Required
In-country Testing Requirement	Requires testing

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