Panama Medical Device Registration

Understanding Medical Device Registration in Panama

Regulatory Authority 

Ministerio de Salud de la República de Panamá (MINSA)

The Ministry of Health of Panama (Ministerio de Salud de la República de Panamá, MINSA) is a ministry of the Republic of Panama that is part of the Executive Branch. This institution is responsible for the health and well-being of the Panamanian population and the general health situation of the country. The ministry was created on January 15, 1969, by Cabinet Decree No. 1.

Link for Regulatory Authority

https://www.minsa.gob.pa/

Local Regulation

• Executive Decree No. 83

Classification of Medical Devices

• • Class A
  • Class B
  • Class C
  • Class D

Listing or Registration Requirements

• Appoint an SR in Panama – Manage submissions and act as DNDM/ MINSA liaison.
• AR must have the operation liaison
• CLASS A: Prepare a basic set of product documents including the QMS certificate
• CLASS B, C &D: Prepare the registration dossier – basic set + additional documents.
  The complexity of the dossier depends on the product class.
• Authorized representative submits the registration documentation to DNDM/ MINSA
• Once the product is approved DNDM issues the Registration certificate that is valid for 10 years
• An additional technical file is required to register a product that is new to Panama

Documents Required for Panama Medical Device Registration

• • 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.

The applicant must submit the regulatory documentation to register their product. All the documents must be kept up to date and available for inspections for the entire period of registration validity. MDRC will prepare your documentation in accordance with DNDM / MINSA regulatory requirements. We will also advise you on device labelling requirements and IFUin accordance with regulations of Panama.

Registration Timeline

The licensing process takes approximately 2 months. Official review time is 60 workdays. If DNDM requests additional information the timeline will be extended over another 60 days.

License Validity

10 years

Special Labelling Requirements

Documents and Labeling must be in Spanish.

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: info@omcmedical.co.uk