Panama Medical Devices Registration Process
The purpose of the registration process is to ensure the safety, quality, and efficacy of medical devices available in the Panamanian market. Here’s a general overview of the medical device registration process in Panama:
- Classification: Determine the classification of the medical device according to Panama’s classification system. The classification is based on the level of risk associated with the device, and it helps determine the necessary documentation and requirements for registration.
- Application Submission: Prepare the registration application dossier, which typically includes the following documents:
- Application form: Provide the required information about the manufacturer, device details, intended use, etc.
- Product technical documentation: Include detailed technical specifications, design information, labeling, instructions for use, and any applicable standards or test reports.
- Manufacturing information: Provide details about the manufacturing process, quality control, and quality assurance procedures.
- Clinical data: Include clinical evaluation reports, if applicable, demonstrating the safety and performance of the device.
- Valid ISO certification: Submit proof of ISO 13485 certification or an equivalent quality management system certification.
- Certificate of Free Sale: Provide a certificate demonstrating that the device is freely sold in the country of origin.
- Review and Evaluation: The MINSA will review the application and supporting documentation to ensure compliance with Panamanian regulations and standards. The evaluation process may involve a review of technical data, safety and performance claims, and clinical evidence, depending on the classification and risk level of the device.
- Inspection (if required): For certain higher-risk devices, an inspection of the manufacturing facility may be conducted to verify compliance with Good Manufacturing Practices (GMP) and quality standards.
- Approval and Registration: If the application meets all the requirements and passes the evaluation process, the MINSA will issue a registration certificate, indicating that the device is approved for sale and distribution in Panama. The registration certificate is typically valid for a specific period and may need to be renewed periodically.
It’s important to note that specific requirements and processes may vary depending on the type of medical device and its classification. It’s advisable to consult with a local regulatory consultant or the Ministry of Health directly.
The U.S. Commercial Service can assist you in identifying opportunities and local partners in the Republic of Panama dairy products sector. To learn more please contact Commercial Specialist Diana Lozano at diana.lozano@trade.gov.