DOH and FDA Guidelines Every Dialysis Center Should Know

Operating a dialysis center in the Philippines goes beyond providing quality care to patients with kidney disease. It also means complying with strict Department of Health (DOH) and Food and Drug Administration (FDA) regulations. These guidelines are not just legal requirements. They help dialysis centers ensure patient safety, maintain credibility, and avoid costly supply chain risks.

If you are running or planning to establish a dialysis facility, here are the essential DOH and FDA guidelines every dialysis center in the Philippines should know.

DOH Guidelines for Dialysis Centers

The Department of Health (DOH) oversees the licensing and accreditation of dialysis centers. Compliance with DOH requirements ensures your facility is legally authorized to operate and provide safe treatments.

1. Licensing and Accreditation

• Dialysis centers must obtain a DOH license to operate before accepting patients.
• Facilities that want to partner with PhilHealth must also secure accreditation, which requires meeting specific standards on equipment, staff, and patient care.

2. Facility and Equipment Standards

• Each dialysis station must have adequate space, proper ventilation, and sanitation measures.
• Centers must use DOH-approved hemodialysis machines and ensure regular maintenance.
• Backup power supply is required to guarantee uninterrupted treatment sessions.

3. Staffing Requirements

• A licensed nephrologist must serve as the medical director.
• Dialysis nurses must be certified and trained in handling dialysis procedures.
• Adequate staffing ratios must be followed to ensure patient safety.

4. Infection Control and Patient Safety

• Centers must implement strict infection prevention protocols, including proper disinfection of machines and use of personal protective equipment (PPE).
• Waste disposal must comply with DOH and local environmental standards.

FDA Guidelines for Dialysis Centers

The Food and Drug Administration (FDA Philippines) regulates all medicines, medical devices, and supplies used in dialysis. Following FDA guidelines helps dialysis centers avoid counterfeit or substandard products. Here are the guidelines for their one-stop shop for licensing.

1. Sourcing from FDA-Licensed Suppliers

• Dialysis centers should only purchase medicines, dialyzers, and other supplies from FDA-licensed distributors.
• Products must have a Certificate of Product Registration (CPR) issued by the FDA.

2. Medicine and Medical Device Compliance

• Erythropoietin, dialysis solutions, and other supportive drugs must be FDA-registered.
• Dialyzers, bloodline sets, and hemodialysis machines must carry valid FDA approval.

3. Storage and Handling Standards

• Medicines and solutions should be stored under proper temperature and conditions.
• Expired or damaged products must be separated and disposed of according to FDA guidelines.

Why Compliance Matters

Following DOH and FDA guidelines does more than keep your dialysis center legally operational—it protects patients and builds long-term trust.

• Patient Safety: Ensures treatments are safe, effective, and consistent.
• Reputation: Shows patients and families that your center values quality and compliance.
• Supply Security: Prevents supply disruptions from non-compliant suppliers.
• Insurance Access: Enables PhilHealth accreditation, helping patients afford long-term dialysis care.

Compliance Checklist for Dialysis Centers

To stay compliant, dialysis center managers should:

• ✅ Renew DOH licenses and PhilHealth accreditation regularly
• ✅ Verify FDA licenses of all medicine and equipment suppliers
• ✅ Maintain updated Certificates of Product Registration (CPR)
• ✅ Train staff on DOH and FDA protocols
• ✅ Keep clear records for inspections and audits

Final Thoughts

Running a dialysis center in the Philippines is both a responsibility and a privilege. By following DOH and FDA guidelines, facilities can ensure that patients receive safe, high-quality treatment while avoiding legal and supply chain risks.

For dialysis centers, compliance is more than a requirement. It’s the foundation of patient trust and long-term success.