Costa Rica Medical Device Regulation

“Costa Rica Medical Device Regulations and Market Overview: Licensing, Import Requirements, and Industry Trends”

Updated on 23/01/24

Regulatory Authority: Ministerio de Salud

The Ministerio de Salud is a government institution that leads social actors in improving physical, mental, and social health through stewardship of the National Health System. It focuses on health prevention, promoting a healthy environment, and respecting diversity. The vision is to become a respected health authority, exercising technical and decision-making capacity, leadership, and social participation. Institutional values include leadership, transparency, commitment, respect, excellence, and loyalty.

Link for Regulatory Authority:https://www.ministeriodesalud.go.cr/

 Local Regulation:

• Law No. 5395
• Decree No. 34482-S
• Decree 32780-S
• DAJ-RM-1151-08

Classification:Class I, II, III, IV

 Listing or Registration Requirements:

• • Class I and II medical devices in Costa Rica have a simplified registration process, while
  • Class III and IV devices will have higher requirements
  • Class III and IV devices that are listed, cleared, or approved with the US FDA are eligible for the simplified registration process
  • FDA approved medical devices have quicker approval process.

Documents Required for Registration:

• All classes require the following documents:
  • The Free Sale Certificate, Certificate of Foreign Government, Certificate of Export or equivalent.
  • Manufacturer’s information: email, telephone number and countrydistributors contact information
  • Medical device classification
• Class II
  • Medical and technical specifications
  • Instructions for use
  • Sterilization process description (if applicable)
  • Pictures of the product.
• Class III
  • Medical and technical specifications
  • Instructions for use
  • Sterilization process description (if applicable)
  • Pictures of the product
  • List of countries where the medical device is sold
  • Post-market surveillance plan
  • Summary of clinical trials demonstrating safety and efficacy
  • Clinical studies reports
  • Packaging information
• Class IV
  • Medical and technical specifications
  • Instructions for use
  • Sterilization process description (if applicable)
  • Pictures of the product
  • List of countries where the medical device is sold
  • Post-market surveillance plan
  • Summary of clinical trials demonstrating safety and efficacy
  • Clinical studies reports
  • Packaging information
  • Reference of published reports related to the use, safety and efficacy of the medical device
  • In the case of medical devices containing tissues and their derivatives of human or animal origin – biological safety certificate.

Registration Timeline:

• Legal evaluation:
  • Class I and II – 15 days upon submission
  • Class III and IV –30 days upon submission of EMB
• Technical evaluation:30 days
• Overall Timeline:
  • FDA approved devices – 3 months approximately
  • Devices without FDA clearance – 8 months approximately

 License Validity:5 Years

 Special Labelling Requirements:IFU and labels in Spanish

 Import requirements:

Importation of pharmaceuticals, drugs, cosmetics, medical devices, and certain chemical products like solvents, agricultural inputs, and precursor chemicals utilized in the production of narcotic drugs necessitates the possession of import permits valid for a duration of five years. Additionally, these products must undergo registration with the Ministry of Health. This regulatory requirement ensures a comprehensive oversight and monitoring mechanism to uphold safety, quality, and compliance standards in the realm of healthcare and chemical industries.

Medical Device market in Costa Rica:

In Costa Rica, medical devices currently contribute significantly, comprising 28% of the total sales within the Precision and Medical Equipment product category, as reported by the Foreign Trade Promoter (Procomer). In the initial month of 2022, this specific product division accounted for 34% of the country’s overall exports, experiencing a substantial growth of 20%, equivalent to US$63 million more than in January 2021. Key contributors to this growth include medical devices, showing a remarkable increase of 28%, along with needles and catheters experiencing a surge of 21%, and equipment for intravenous injection witnessing an outstanding growth rate of 124%. This positive trend underscores the pivotal role played by the medical devices sector in driving export expansion, reflecting both the industry’s significance in the national economy and its substantial contribution to export performance in the early months of the year.

Costa Rica has emerged as the second-largest exporter of medical devices in Latin America, positioned just behind Mexico, according to the latest statistics. These figures underscore Costa Rica’s significant role in the regional market for medical devices, highlighting its standing as a key player in the industry. The country’s substantial export performance in this sector positions it as a noteworthy contributor to the overall dynamics of the Latin American medical devices market, showcasing its competitiveness and strength in international trade within the industry.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]