DRAFT EXECUTIVE DECREE — MEDICAL DEVICES OF PANAMA (2025)

DOCUMENT: DRAFT EXECUTIVE DECREE — MEDICAL DEVICES OF PANAMA (2025) / Regulation of Law 90 of 2017 and Law 92 of 2019

COMPETENT AUTHORITY: National Directorate of Medical Devices (MINSA)

EFFECTIVE DATE: 6 months after its promulgation

DURATION OF PUBLIC CONSULTATION: Conducted over a 90-day period, from October 15, 2025, to December 19, 2025.

CONTACT TO SUBMIT COMMENTS:
eaguilarg@minsa.gob.pa

SUMMARY OF THE DRAFT EXECUTIVE DECREE ON MEDICAL DEVICES

TITLE I – General Provisions

Chapter I – Definitions

  • Includes more than 100 new internationally harmonized definitions (IMDRF/GHTF).
  • Defines essential technical concepts such as:
    Medical Device, Software as a Medical Device (SaMD),
    Substantial Change, Supplementary Label,
    Technical Criteria Certificate,
    In Vitro Diagnostic Medical Device (IVDMD),
    Implantable Registry,
    Traceability Protocol, among others.
  • Introduces terminology related to risk, biocompatibility, traceability, safety, efficacy.
  • Establishes risk classification (A–D) aligned with the international harmonized standard.

Chapter II – Competence

  • Formally creates the National Directorate of Medical Devices (DNDM) within MINSA as the competent authority.
  • The DNDM regulates manufacturing, import, export, storage, marketing, labeling, and final disposal.
  • Its functions include:
    • Issuing, renewing, suspending, or canceling operating licenses and sanitary registrations.
    • Authorizing Technical Criteria Certificates and Certificates of Free Sale.
    • Monitoring compliance and applying sanctions.
    • Creating surveillance units and a national implantable registry.

Chapter III – Structure of the National Directorate of Medical Devices

  • Defines the internal organizational structure by ministerial resolution.
  • Authorizes salary compensations and bonuses for technical personnel.
  • Requires staff to maintain information confidentiality.
  • Recognizes Technical Administrative Units (UTAs) in entities such as the Social Security Fund and the Gorgas Institute.

Chapter IV – Management

  • Instructs MINSA to provide human, technological, and infrastructure resources to the DNDM.
  • The DNDM must develop mandatory procedures, forms, and operational manuals.
  • Promotes digitalization of procedures in coordination with the Government Innovation Authority (AIG).
  • Sets requirements for international authentication (Apostille) and translation into Spanish.
  • Requires all electronic documents to be verifiable through authenticity links.
  • Demands full product traceability from manufacturing to final distribution.

Chapter V – Service Fees

  • Official fees to be paid for applications:
    • Licenses: B/.150.00 – B/.350.00
    • Sanitary Registrations: B/.150.00 (Class A) –
      B/.1,000.00 (Class C/D per family)
    • Certificates of Free Sale: B/.500.00
    • Authorizations and imports: B/.100.00
  • Funds collected are self-managed to strengthen the DNDM.
  • Fees will be reviewed every three years.

TITLE II – Regulation of Medical Device Commercializers

Chapter I – Quality Audits

  • The DNDM will issue Good Manufacturing, Storage, and Distribution Practices Certificates gradually.
  • Requires trained technical staff for inspections and audits.

Chapter II – Operating License

  • All natural or legal persons who manufacture, import, store, or market must hold an Operating License issued by the DNDM.
  • Validity:
    • Manufacturer / Conditioning Facility: 5 years
    • Distributor / Retail / Warehouse: 2 years
  • Renewal: 60 business days before expiration.
  • Requirements: form, rental contract, public registry, photos/videos of facility, ISO 13485 (for manufacturers), location map, payment receipt.
  • Prohibited: operating in residential areas, subleasing, using mini-storages.

TITLE III – Sanitary Registration Certificate of Medical Devices

Chapter I – Sanitary Registration

  • All medical devices in national territory must have a sanitary registration.
  • Exception: Class A (low risk) requires only inscription.
  • Validity: 5 years.
  • Renewal: 120 business days before expiration.
  • Implements the Regulatory Reliance Process.
  • Evaluation timelines:
    • 30 business days (regular)
    • 45 business days (reliance)
  • Corrections: 60 business days; extensions up to 60 days.

TITLE IV – Technical Criteria Certificate

  • Applicable during gradual implementation of full sanitary registration.
  • Issued by the DNDM and authorized entities for public-sector procurement.
  • Certifies product safety and performance.
  • Valid only during the transition.

TITLE V – Surveillance and Technovigilance

Chapter I – National Surveillance Program

  • Creates the National Medical Device Surveillance Program.
  • Participants include: MINSA, Surveillance Departments, UTAs, hospitals, manufacturers, distributors, and health professionals.
  • Collects and reports adverse events, recalls, and safety alerts.
  • Supports policy development and cooperation with WHO/PAHO.
  • Defines procedures for issuing national safety alerts.

Chapter II – Responsibilities and Structure

  • Creates Technical Surveillance Units (UTV) in public and private hospitals.
  • Requires mandatory reporting of adverse events.
  • Requires manufacturers and suppliers to maintain full traceability and document failures.
  • Involves training and communication activities.

TITLE VI – Final Disposal of Products

  • The DNDM may order final disposal or re-export of risky products.
  • Disposal must be done by companies authorized by the General Directorate of Public Health.
  • Applies to recalls, alerts, expiration, or failures.

TITLE VII – Final and Transitional Provisions

  • Article 223: Mandatory registration will be gradual:
    • Class D → 3 months
    • Class C → 6 months
    • Class B → 9 months
  • Article 226: Applications in process will be accepted up to 5 months after signing.
  • Article 227: Decree enters into force 6 months after promulgation.
  • Repeals previous regulations.

REGULATORY REQUIREMENTS BY RISK LEVEL

Risk Level Type of Management Main Requirements Fee (B/.) Special Notes
Class A Inscription • General Requirements: Signed form.
• ID or passport.
• Notarized authorization (if applicable).
• Valid DNDM operating license.
• MICI commercial notice.
• Public registry certificate.
• Product catalog or technical sheet.
• Instructions for use (if applicable).
• ISO 13485 or GMP.
• Manufacturer letter.
• Sworn statement.
• Payment receipt.		 Individual: 150.00
Family: 250.00		 Does not require sanitary registration.
Class B Sanitary Registration • All general requirements.
• Technical catalog, instructions, literature.
• Sterilization method (if sterile/reusable).
• Certificate of Free Sale.
• Official translations and apostilles.		 Individual: 400.00
Family: 600–850.00		 Document and technical evaluation.
Class C Sanitary Registration • All Class B requirements.
• Clinical evaluation report.
• Manufacturing process description.
• Packaging process flowchart.		 Individual: 550.00
Family: 900–950.00		 Higher-risk evaluation.