Mexico has become the hub for manufacturing for export in many different market segments. The medical device segment is no exception. In fact, the aggregate value of production derived from medical device manufacturing in Mexico in 2011 was an estimated $8.6 billion USD, and it’s growing. Mexico’s National Institute of Statistics and Geography (INEGI) expects the value of medical device production in Mexico to total nearly $15 billion USD by 2020. Given these numbers, QSR compliance in Mexico is of critical importance.

Areas of Responsibility

An important part of manufacturing within the export medical device segment is of course quality assurances that will satisfy the requirements of the US Food and Drug Administration (FDA). For medical device manufacturers seeking to sell in to US markets, implementation of a quality system covering the design, manufacture, packaging and labeling, storage and delivery of these medical devices is required, pursuant to 21 CFR Part 820 of US Code of Federal Regulations. These requirements, commonly referred to as Quality System Regulation (QSR), are fully explained in the FDA’s code, and include the following areas:

  • Management responsibilities
  • Internal quality audits
  • Personnel qualification and training
  • Design controls
  • Document and purchasing controls
  • Identification and traceability
  • Production and process controls
  • Process validation
  • Policies for acceptance activities, non-conformance, corrective & preventative actions, and distribution

Definition and Exemptions

QSR compliance in Mexico, and elsewhere, applies to finished device manufacturers intending to commercially manufacture and distribute medical devices, which are defined as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. This includes some components like blood tubing and diagnostic x-ray components, due to the fact that they are accessories to finished devices. There are certain exemptions to these requirements, however. The FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892 have exempted some devices from GMP requirements, although not from the requirement on manufacturers to keep complain files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).


QSR compliance in Mexico in companies in which medical devices are manufacured, occurs across five general stages or phases of implementation over the course of several months, depending on the size of the organization:

1. Analysis/Planning: identifying strengths and vulnerabilities by conducting GAP analysis of existing quality assurance processes; developing plans and schedules for FDA cGMP implementation andconducting awareness training
2. Documentation Development: setting forth quality policy and objectives, quality system procedures, the quality manual, and other necessary forms; establishing document control, design,development, etc.
3. Policy Implementation: implementing the process of following procedures and policies and demonstrating compliance
4. Internal Auditing: conducting internal audits to determine the readiness of the FDA QSR quality system
5. Monitoring: identifying any vulnerabilities or weak points based on analysis of audits in order to establish full compliance

Before setting up medical device manufacturing plants, companies must make certain that their level of QSR compliance in Mexico is in coincidence with FDA requirements and demands.