Panama clinical trial regulatory guide

Regulator: MINSA (Ministerio de Salud)

Panama is emerging as one of the fastest regulatory environments for FIH clinical trials in Latin America. MINSA's streamlined approval process, combined with the country's dollarized economy, modern healthcare infrastructure, and strategic geographic location, makes it an ideal choice for medtech startups seeking rapid first-in-human data. Panama accepts non-GLP animal study data for certain device categories.

Approval process

1. Ethics Committee Approval. Submit to a CNBI-registered national or institutional ethics committee. Panama's streamlined process enables rapid review.
2. MINSA Authorization. Submit clinical trial application to MINSA's Directorate of Drugs and Pharmacy. Includes protocol, device dossier, and ethics approval.
3. Import Authorization. Obtain import permit through MINSA for investigational devices.
4. Site Activation. Finalize site contracts and begin enrollment.

Ethics requirements

• CNBI-registered ethics committee approval required
• Informed consent in Spanish
• Participant insurance required
• Annual continuing review
• Expedited review available for minimal-risk studies

Documentation requirements

• Clinical trial protocol (Spanish translation)
• Investigator brochure
• Device technical file
• GMP/ISO 13485 certificates
• Insurance documentation
• Investigator CV and GCP training

Device registration

Panama's device registration through MINSA follows a simplified pathway for devices with prior FDA or CE approval. Registration typically varies by study (we confirm it per protocol) and requires a local representative.

FDA acceptance of Panama data

FDA accepts Panamanian clinical data under 21 CFR 812.28. Panama's dollarized economy eliminates currency risk, and the country's modern healthcare facilities and experienced investigators produce high-quality data suitable for FDA submissions. bioaccess® has extensive experience generating FIH data in Panama for FDA IDE pathways.

Key contacts

• MINSA — Ministry of Health
• CNBI — National Bioethics Committee

Frequently asked questions

Why is Panama one of the fastest for FIH trials?

MINSA's streamlined process, smaller bureaucracy, and supportive government policies enable study-specific approval timelines.

Does Panama accept non-GLP data?

Yes, MINSA may accept non-GLP preclinical data for certain device risk categories, reducing pre-clinical costs.

What about currency risk in Panama?

Panama uses the US Dollar, eliminating currency exchange risk — a significant advantage over other LATAM markets.

Can Panamanian FIH data support FDA submissions?

Yes, bioaccess® has successfully used Panamanian FIH data in FDA IDE and 510(k) submissions.

How does Panama compare to Colombia for FIH?

For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included.

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