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Expand your medical devices into new markets with the support of regulatory affairs experts.

Cedeño & Méndez

We simplify the process so your company can operate with confidence in new markets.

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Expanding your medical devices into new markets in Panama, Costa Rica, Guatemala, El Salvador, Honduras, and Nicaragua requires in-depth knowledge of regulations and an efficient process for sanitary registration, importation, and commercialization. At Cedeño & Méndez, we have a team of regulatory affairs specialists, including lawyers, pharmacists, and chemists, who guide you through every stage to ensure your products meet the requirements of each country.

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Here, you will find essential information on medical device registrations in the region, making it easier for your company to operate with confidence. If you are looking for an experienced team with agile solutions to ensure regulatory compliance, contact us and let’s move forward together.

30+ years of experience in regulatory affairs for the healthcare industry in Central America.

Multidisciplinary team of lawyers, pharmacists, and regulatory specialists.

Personalized and centralized advisory services in six countries with no intermediaries.

Panama

In Panama, the regulation of medical devices is overseen by the National Directorate of Medical Devices of the Ministry of Health (MINSA). The basic requirements include:

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  • Sanitary Registration: Mandatory for all medical devices before commercialization in the country.

  • Operating License: Establishments that manufacture, import, distribute, or commercialize medical devices must obtain an operating license issued by MINSA.

  • Labeling: Must comply with established regulations, including information in Spanish, such as product name, manufacturer, expiration date, and other relevant details.

  • Good Storage and Distribution Practices: Establishments must follow the guidelines set forth in Resolution No. 001 of January 5, 2021.

Meet our Specialists
at HOSPITALAR 2025

Comprehensive 
Regulatory Solutions 

Also specializing in regulatory compliance for a broad range of product categories:​​

  • Food and Beverage

  • Hygiene and Cleaning

  • Cosmetics

  • Food Supplements

  • Agrochemicals

  • Pharmaceuticals

  • Pesticides

  • Diagnostic Reagents

  • Veterinaries

Other Legal Services
PANAMA

Also specializing in regulatory compliance for a broad range of product categories:

  • Corporate and Business Law

  • Estate Planning

  • Litigation & Arbitration

  • Labor Law

  • Real Estate

  • Administrative Law and Regulated Activities

  • Immigration Law

  • Intellectual Property*

  • Competition Law

  • C&M Accounting & Tax Solutions

*Panama Firm of the Year | Managing IP Americas Awards

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