What is NOM-241-SSA1-2012 and why is it important?

NOM-241-SSA1-2012 establishes Good Manufacturing Practices (GMP) for medical device establishments in Mexico. Published October 19, 2012, it ensures quality throughout production. Aligned with ISO 13485 international standards.

Who must comply with NOM-241-SSA1-2012?

All establishments manufacturing, assembling, or packaging medical devices in Mexico. Includes domestic manufacturers, foreign companies with Mexican facilities, contract manufacturers, and sterilization service providers.

How does NOM-241-SSA1-2012 relate to ISO 13485?

NOM-241-SSA1-2012 is harmonized with ISO 13485:2003. Companies with ISO 13485 certification meet most requirements. Mexico-specific provisions still apply. ISO certification simplifies compliance but doesn't replace NOM-241.

What are the Quality Management System (QMS) requirements?

QMS must include quality policy, objectives, quality manual, documented procedures, work instructions. Process approach required. Management responsibility clearly defined. Resource management addressed. Measurement and improvement processes established.

What are the document and record control requirements?

All documents must be approved before use. Version control required. Changes documented. Obsolete documents removed. Records must be legible, identifiable, retrievable. Retention periods defined. Protection from damage maintained.

What are the design and development control requirements?

Design controls required for manufacturers. Must include planning, inputs, outputs, review, verification, validation, and change control. Risk management integrated throughout. Design transfer to production validated. Design history file maintained.

What are the risk management requirements?

Risk management required throughout product lifecycle. Risk analysis must identify hazards. Risk evaluation and control measures implemented. Residual risks assessed. Post-production monitoring maintained. ISO 14971 methodology recommended.

What production and process control requirements apply?

Production must be planned and controlled. Work instructions required. Equipment qualified and maintained. Environmental controls for sensitive processes. Product identification and traceability maintained. Status identification throughout production.

What are the requirements for sterilization processes?

Sterilization processes must be validated. Sterility assurance level (SAL) defined. Validation includes installation, operational, performance qualification. Routine monitoring required. Revalidation after changes. Records maintained. Sterility maintenance packaging validated.

What are the purchasing and supplier control requirements?

Suppliers must be evaluated and approved. Purchasing documents specify requirements. Incoming inspection performed. Critical components identified. Supplier performance monitored. Re-evaluation conducted periodically. Supplier agreements maintained.

What are the complaint handling and adverse event reporting requirements?

Complaint system required to receive, review, investigate complaints. Adverse events reported to COFEPRIS within regulatory timeframes. Investigation determines root cause. Corrective actions implemented. Trending analysis conducted. Records maintained.

What are the corrective and preventive action (CAPA) requirements?

CAPA system required for addressing nonconformities. Root cause analysis mandatory. Corrective actions address existing problems. Preventive actions prevent potential problems. Effectiveness verified. Documentation maintained. Management reviews CAPA data.

What are the internal audit requirements?

Internal audits required at planned intervals. All QMS elements audited. Audit schedule based on process importance and previous results. Auditors independent of audited area. Findings documented. Corrective actions verified. Management reviews audit results.

NOM-241-SSA1-2012 FAQ - Updated October 2025

Mexico Good Manufacturing Practices for Medical Device Establishments. Expert guidance by Pure Global regulatory specialists

COFEPRIS Regulation

Effective October 19, 2012

ISO 13485 Alignment

GMP Requirements

Official Document

Access the official document:Download NOM-241-SSA1-2012 (Spanish PDF)

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Scope

All Manufacturers

Domestic & foreign facilities

Standard

ISO 13485

Harmonized alignment

Authority

COFEPRIS

Health regulatory agency

Documentation

Comprehensive

QMS manual & procedures

Frequently Asked Questions

On This Page

General Questions

Quality Management System

Design & Development

Production & Process Controls

Purchasing & Supplier Management

Monitoring & Improvement

Quick Resources

All Mexico Regulations Mexico How-To Guides Pure Global Mexico Services

Key Dates & Milestones

PublishedOct 19, 2012

EffectiveOct 19, 2012

StandardISO 13485:2003

Key Requirements

Quality Management System

Design Controls

Production Validation

Supplier Management

CAPA System

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on NOM-241-SSA1-2012 official documentation