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GMP Requirements

This page summarises the core Good Manufacturing Practice (GMP) requirements under NOM-241-SSA1-2025 for medical device manufacturers, importers, and supply chain partners in Mexico.

Management responsibility​

  • Establish and document a quality policy and quality objectives.
  • Define organisational structure and responsibilities for quality.
  • Conduct regular management reviews of the quality system.
  • Designate a management representative with authority over quality functions.

Design controls​

  • Maintain documented design and development procedures.
  • Conduct design reviews, verification, and validation at appropriate stages.
  • Maintain a Design History File (DHF) or equivalent design record.
  • Ensure design output meets design input requirements before release.

Document and record controls​

  • Maintain controlled documents with version history and approval records.
  • Retain manufacturing, distribution, and quality records per defined retention periods.
  • Ensure traceability from raw materials through to distribution (critical for recalls).

Purchasing controls​

  • Qualify and monitor approved suppliers for critical components and materials.
  • Define supplier quality requirements in purchasing documents or agreements.
  • Conduct periodic supplier audits based on risk.

Production and process controls​

  • Validate manufacturing processes that cannot be fully verified by inspection.
  • Monitor and control process parameters at defined control points.
  • Maintain batch/lot records traceable to finished device distribution.

CAPA — Corrective and Preventive Action​

The CAPA system is the backbone of continuous improvement:

  • Identify sources of non-conformity (complaints, audits, process data, technovigilance).
  • Investigate root cause.
  • Implement corrective actions and verify effectiveness.
  • Implement preventive actions to eliminate potential non-conformities.
  • All CAPAs must be documented and reviewed by management.

Complaint handling & technovigilance interface​

  • Maintain a documented complaint handling procedure.
  • All complaints must be assessed for reportability under NOM-240 technovigilance obligations.
  • Complaints that meet adverse event criteria must be escalated to the MRH for CNFV reporting.
  • Complaint records must be retained and summarised in the Technovigilance Report at renewal.

Chapter 19 — Warehousing & distribution​

NOM-241 Chapter 19 specifically addresses storage and distribution:

  • Temperature and humidity control — storage conditions must be appropriate for each device type and validated.
  • Segregation — quarantine, approved, and rejected stock must be physically separated.
  • Distribution records — traceable to lot/serial number and customer.
  • Returns and complaints — documented handling of returned product.
  • Third-party logistics — the MRH/importer retains responsibility even when logistics are outsourced; technical agreements must define responsibilities.

Technical agreements with distributors​

NOM-241 requires written technical agreements between the MRH and each distributor, specifying:

  • Storage and handling requirements.
  • Adverse event reporting obligations and escalation timeframes.
  • Record-keeping responsibilities.
  • Returns and recall procedures.
  • Audit rights.