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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 or testing alone, particularly sterilisation processes, manufacturing steps critical to device performance, and any new or modified manufacturing process prior to commercial release.
  • 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.

Document and record controls​

"Record Retention: Manufacturing, quality, and distribution records must be retained for a minimum of the device lifetime plus 2 years, or as specified in the approved technical dossier, whichever is longer. Traceability must permit identification of: raw material lot to finished device lot, finished device lot to distributed units (by serial number or lot), and distributed units to customer/patient location where applicable. Traceability must enable rapid product recalls or market withdrawals."