ULTIMATE GUIDE FOR REGULATORY AFFAIRS IN COSTA RICA
In Veraque we are interested in providing you with the latest news and detailed information about regulatory and quality affairs in Costa Rica. This is a great resource in case you are looking for an in-depth description of the full regulatory process for medical devices in Costa Rica.
For a general overview, you can check our website for each of the services we provide or contact us directly. We will be glad to send the information you are looking for. Also, if you are still not sure if your product is a medical device, we invite you to check our ultimate guide for classification and grouping in Costa Rica. This is a good reference for the first step to get your medical devices approved in the Costa Rican market.
To facilitate your information search, this guide details each of the following topics:
- Inside the Ministry of Health (MoH) in Costa Rica
- The legal framework surrounding a medical device in Costa Rica
- The stakeholders in a regulatory project in Costa Rica
- The routes to register a medical device
- Timelines
- What a prevention is
- Useful references
You can check any chapter independently if you are looking for a specific topic.
Inside the Ministry of Health in Costa Rica
According to the General Law of Health in Costa Rica, health is considered a public priority and it is protected by the State.
For this purpose, the Ministry of Health of Costa Rica (MoH) exercises the rectory of the National System of Health and is in charge of the regulation of medical supplies.
The legal framework surrounding a medical device in Costa Rica.
The first step is to identify if your product is a medical device. You can check more about this in our Classification and Grouping Guide.
Once you have identified if your products are medical devices, you need to prepare all the paperwork to receive a sanitary registration based on specific requirements. As in any other country, these requirements are generally based on a legal framework.
In this section we provide a quick introduction to the main legal references that will help to bolster your dossier (the set of documents submitted to the local authority).
Regulations
- General Health Law No. 5395
- Decree No. 34482-S: Regulation for the registration, classification, importation, and control of biomedical equipment and material. These are some of the relevant topics discussed in this document:
- Definition of what a Biomedical Equipment and Material (EMB – Equipo y Material Biomédico) is – local definition for a medical device in Costa Rica. Throughout this document we will refer to EMB or Medical Device indistinctively.
- Classification of the EMB, according to its sanitary risk, into four categories. These categories or classifications are based on what is recommended by the Pan American Health Organization (PAHO) for Latin America, as well as the global harmonization efforts.
- Specification of the information that the EMB labeling should contain.
- Clarification that the validity of a registration is 5 years.
- That all EMB must be sold and provided by a national manufacturer or from an importer authorized by the Ministry of Health with their current operation permit.
- Decree No. 32780-S
- This document defines the registration, inspection, surveillance, and control service fees.
- Decree No. 39342-S: Regulation of the Technovigilance National System.
- Defines what Technovigilance is.
- Establishes the types of events and factors that should be considered during a risk assessment.
- Determines the manufacturer, importer, distributor, health professional, and user roles in the Technovigilance system.
Something important to highlight is that the regulatory requirements for products approved by the FDA in the USA are less in Costa Rica. This is part of the Ministry of Health recognition of international agencies.
The stakeholders in a regulatory project in Costa Rica
- Manufacturer: responsible for the design, manufacture, packaging and labeling of an EMB (medical device).
- Registration holder: manages the sanitary registration and acts as legally responsible. This must be a Costa Rican entity.
- Product holder: entity that owns the products to be commercialized under a specific name or brand. The product holder is what is generally considered as the legal manufacturer in other countries. It could be the same manufacturer.
The routes to register a medical device
Once we have clarified the legal framework and requirements, a sanitary registration route must be identified.
The most popular registration process is the Standard Process.
In this route, a dossier must be prepared fulfilling the requested documents and information in the right order according to the regulations.
The application of the registration is done via the system “registrelo” that requests you to have a digital signature. This signature is processed personally by the Registration Holder.
Once the dossier is delivered, a proof of reception is granted in the system. At this moment the Ministry of Health begins the evaluation.
The Ministry of Health will carry out the evaluation in two phases:
- A) Legal evaluation: The Ministry of Health verifies the conformity of the submitted paperwork in terms of the validity and authenticity of the legal documents. The Ministry of Health will take a period of 15 days upon submission of EMB (medical devices) class I and II, and a period of 30 days upon submission of EMB class III and IV.
- B) Technical evaluation: Another department within the Ministry of Health will perform the technical evaluation. This evaluation will take a period of 30 days upon submission.
Consider that the mentioned timelines are the legal periods of time. Check the section for timelines as mentioned in this document below for more details about the real timelines.
If the technical evaluation is qualified as positive, the registration will be granted and the corresponding certificate issued. The EMB (medical device) is now considered as approved by the Ministry of Health in Costa Rica for its use, importation, distribution and commercialization.
Considerations according to the device classification
The EMBs (medical devices) listed in the Annex 1 of the decree No. 34482-S, are not required to be registered. In addition, based on the Decree No. 41387-S, the entire group of EMB (medical devices) considered class I, are exempt of registration.
These products require a series of basic documents.
In addition to the documents required for class II products, more clinical and performance data is required to ensure its safety and effectiveness.
Timelines
- For FDA approved devices, it takes 3 months approximately upon submission.
- For products without FDA clearance, it takes 8 months approximately upon submission.
What is a prevention
When applying for a registration, the regulatory teams of different companies often experience that the competent authority requests additional information — either to complement or clarify a particular situation. Costa Rica is not an exception. The Ministry of Health (MoH) may also issue this request that is known as prevention. In the case of this market, this process includes the following considerations:
Phase 1: Legal requirements review.
In the event that the documentation and requirements requested for the sanitary registration are not in compliance, the Ministry of Health may issue a prevention to the interested party.
The interested party (or applicant) has a period of 10 business days to respond to the requisition.
An additional period of up to 3 months might be conceded, unless the situation from a technical point of view turns out to be complex, in which case a longer period is conceded.
In the case that the applicant does not respond before the expiration of the period of the initial 10 business days or even the additionally granted period, the application is considered as cancelled. In such case a new procedure must be started.
Phase 2: Technical evaluation of the requirements:
In case the revision of technical reports results in a non-compliant result, the Ministry of Health (MoH) will issue a prevention, giving the applicant 10 business days to gather the missing documents and respond.
If the period of 10 business days expires without receiving the information and clarifications from the interested party, the application will be cancelled, and the application would have to start over.