Medical Device Regulations: What You Need to Know About COFEPRIS and FDA

Key Regulations for Medical Device Manufacturing

Medical device manufacturing in Mexico is primarily regulated by COFEPRIS at the national level and by the FDA for exports to the United States.

NOM-241-SSA1-2021

This standard establishes Good Manufacturing Practices for medical devices. The most relevant points for clean rooms include:

• Area classification: Defines controlled zones according to device type
• Environmental monitoring: Frequency and parameters for particle, temperature and humidity monitoring
• Installation qualification: IQ, OQ and PQ requirements for HVAC systems
• Documentation: Maintenance, calibration and validation records

FDA 21 CFR 820

For companies exporting to the U.S., the FDA establishes additional requirements under the Quality System Regulation:

• Design Controls: Documentation of clean room design and its relationship to the product
• Production Controls: In-process controls during operation
• Environmental Monitoring: Continuous environmental monitoring program

What Do Auditors Verify?

During an audit, inspectors verify:

1. That clean room classification matches the device type
2. Particle monitoring and environmental condition records
3. Measurement equipment calibration certificates
4. Cleaning and maintenance protocols
5. Current HVAC system qualification

Preparation with Sinergix

Our process includes complete documentation preparation for audits. Each project delivers IQ/OQ/PQ qualification folders ready to present to COFEPRIS or FDA.