Panama Healthcare Product Registration

Law 419, enacted on February 1, 2024, regulates importation, manufacturing, commercialization, and registration of medicines and medical devices in Panama. This law aims to improve the efficiency, safety, and quality of health products available in the country, while aligning Panama’s regulations with international standards. A key aspect of the law is the expedited registration process for products from High Standard Countries (HSCs), such as the United States and European Union, making Panama an increasingly attractive market for global pharmaceutical and medical device companies.

Companies in the pharmaceutical and medical device sectors should see quicker market access and a more transparent procurement process, though they will need to adapt to the new regulatory and procurement environment.

The purpose of Law 419 modernize the regulatory framework for medicines, medical devices, and health products to ensure safety and align with international best practices.  The law covers a wide range of health-related products, including pharmaceuticals, medical devices, diagnostics, cosmetics, and personal care products. The law fast-tracks the registration of medicines and devices from countries with high regulatory standards like the U.S., EU, and others, ensuring faster market entry for these products.  With the law’s focus on reducing registration times, there are growth opportunities for international pharmaceutical and medical device companies looking to enter Panama’s growing healthcare market.

1. Expedited Registration for High Standard Countries (HSCs):
   1. Products approved by regulatory agencies in HSCs (e.g., U.S. FDA, EMA) are fast-tracked for registration in Panama.
   2. This provision eliminates the need for additional clinical trials or redundant evaluations, reducing time-to-market.
2. Procurement Reforms:
   1. Introduces seven contractor selection models to enhance transparency and efficiency in the procurement of health products.
   2. Procurement models cater to varying levels of contract value, including Agile Minor Purchases (up to B/.50,000) and Minor Contracting (up to B/.70,000).
3. Pharmacovigilance and Safety Monitoring:
   1. Panama strengthens its pharmacovigilance system to ensure ongoing monitoring of the safety and efficacy of medical products.
   2. Aligns with international standards for post-market surveillance of medicines and medical devices.

For more information related to Law 419, please visit the Ministry of Health website.

The U.S. Commercial Service in Panama City stands ready to support U.S. companies in their government procurement pursuits in Panama. For further information, please contact your local U.S. Commercial Service office in the U.S. or Commercial Specialist Diana Lozano at diana.lozano@trade.gov.