Regulatory Compliance Requirements in Costa Rica: A Comprehensive Guide

In a rapidly changing regulatory landscape, understanding the requirements for medical device registration in Costa Rica is crucial for any company looking to enter this market. This guide provides an in-depth overview of the regulatory process, highlighting key stakeholders, legal framework, and timelines involved.

Inside the Ministry of Health (MoH) in Costa Rica

According to the General Law of Health in Costa Rica, health is considered a public priority and is protected by the State. The Ministry of Health (MoH) exercises the rectory of the National System of Health and is responsible for regulating medical supplies, including medical devices.

The Legal Framework Surrounding Medical Devices in Costa Rica

To register a medical device in Costa Rica, companies must first identify whether their product falls under the definition of a biomedical equipment and material (EMB). The EMB classification system is based on its sanitary risk, with four categories: Class I, II, III, and IV. Companies must also ensure that their labeling meets specific requirements.

Key Stakeholders in a Regulatory Project

A regulatory project involves several stakeholders:

• Manufacturer: responsible for the design, manufacture, packaging, and labeling of an EMB
• Registration Holder: manages the sanitary registration and acts as legally responsible
• Product Holder: entity that owns the products to be commercialized under a specific name or brand

Routes to Register a Medical Device in Costa Rica

There are several routes to register a medical device in Costa Rica. The most popular is the Standard Process, which involves preparing a dossier with all required documents and submitting it through the “registrelo” system.

Timelines for Registration

The Ministry of Health (MoH) provides legal timelines for evaluation:

• 15 days for Class I and II devices
• 30 days for Class III and IV devices

However, actual approval times may vary due to operational capacity.

What is a Prevention?

A prevention is a request from the competent authority to provide additional information or clarify a particular situation. In Costa Rica, this process includes two phases: legal requirements review and technical evaluation of the requirements.

Useful References

For companies looking to navigate the complex regulatory landscape in Costa Rica, it is essential to have access to reliable resources and expert guidance. This article provides a comprehensive overview of the regulatory requirements for medical device registration in Costa Rica, helping companies make informed decisions about their market entry strategy.