Praxismed Technologies Inc. is committed to full adherence with all applicable national and international laws, regulations, and industry standards governing the distribution, marketing, installation, servicing, and support of medical devices and healthcare technologies in the Philippines.

Compliance with Philippine Regulatory Authorities

Praxismed Technologies Inc. operates in accordance with the regulatory requirements of the:

  • Department of Health (DOH)
  • Food and Drug Administration (FDA Philippines)
  • Center for Device Regulation, Radiation Health and Research (CDRRHR)
  • Professional Regulation Commission (PRC) standards related to clinical practice and biomedical engineering
  • National Privacy Commission (NPC) for the handling of personal and sensitive information

All medical devices, consumables, and technologies distributed by the Company are sourced exclusively from manufacturers that maintain valid certifications and have secured the necessary product registrations, clearances, or authorizations required for lawful distribution in the Philippines.

International Standards and Industry Best Practices

Praxismed Technologies Inc. ensures that its product portfolio meets or exceeds recognized global standards, including, where applicable:

  • ISO 13485 – Quality Management Systems for Medical Devices
  • ISO 14971 – Risk Management for Medical Devices
  • IEC 60601 Series – Standards for Electrical Medical Equipment
  • Good Distribution Practice (GDP) principles
  • Manufacturer-specific compliance requirements and technical documentation protocols

Our international partners uphold stringent quality controls, regulatory certifications, and conformity assessments to ensure that all products meet global safety, efficacy, and performance standards.

Ethical and Transparent Operations

Praxismed Technologies Inc. conducts its operations according to the highest ethical and professional standards. This includes:

  • Transparent communication of product capabilities and limitations
  • Compliance with promotion and advertising guidelines for medical devices
  • Accurate representation of product specifications and intended use
  • Strict avoidance of misleading, exaggerated, or unverified claims

We further ensure that clinical training, product demonstrations, and educational programs remain compliant with regulatory and ethical requirements.

Regulatory Documentation and Audit Readiness

The Company maintains comprehensive and up-to-date documentation covering:

  • Product registrations and certificates
  • Importation and distribution records
  • Quality control and preventive maintenance logs
  • Technical service reports
  • Supplier compliance documentation

Praxismed Technologies Inc. remains prepared for regulatory inspections, audits, and compliance reviews at all times.

Commitment to Continuous Compliance

We continuously monitor updates to DOH, FDA, and international regulatory frameworks to ensure ongoing compliance. Our team participates in ongoing training, certification programs, and policy updates to uphold the highest levels of regulatory integrity.