September 8, 2021
QMS Requirements for Medical Device Compliance in Mexico

Medical devices in Mexico are regulated by the Secretariat of Health (Secretaría de Salud). Article 262 of the Mexican General Health Law requires all medical devices to be registered with the Secretariat of Health before being placed in Mexico. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) oversees the registration process of healthcare products. The Regulatory structure is composed of mandatory standards that are known as Normas Oficiales Mexicanas (NOM) and voluntary standards that are known as Normas Mexicanas (NMX). COFEPRIS has outlined the QMS requirement for medical devices sold in Mexico under the mandatory standard NOM-241-SSA1-2012, “Good Manufacturing Practices for establishments engaged in the manufacture of medical devices”.

NOM-241 is in alignment with International and Mexican standards like

  • ISO 13485:2003
  • ISO 149669:2004
  • ISO 9000:2005
  • ISO 9001:2008
  • NMX-CC-9000-IMNC-2000
  • NMX-CC-9001-IMNC-2000

According to the guideline, “The implementation of Good Manufacturing Practices (GMP) is a fundamental part of a quality management system, which is a strategic decision of the Organization; the design and implementation thereof is influenced by the manufactured product, the followed process, size, and structure of the Organization.” A valid GMP certification is required for all the applicable manufacturing sites where a medical device is being manufactured. 

The QMS Mexico requirements shall be in place, and the GMP regulations shall be followed irrespective of the risk class of the medical device, and the size of the manufacturing site, and the product. NOM-241 provides guidance on COFEPRIS expectations on organization of the establishment, requirements for personnel, documentation, manufacturing facility, production control, equipment, product recalls, validation, audits, and other necessary requirements for compliance.

COFEPRIS, on behalf of the Ministry of Health (MoH), is responsible for the device manufacturer’s GMP compliance vigilance as required under NOM-241. The Sanitary Responsible Person and Legal representative may request for the compliance assessment by COFEPRIS. The concerned stakeholder must submit an application form to COFEPRIS along with required QMS medical device documentation and the fees payable to COFEPRIS for GMP site inspection and certification.

The Medical Device QMS documents that shall be submitted along with the application include –

  • Name, address, and other general details of the manufacturing establishment (facility)
  • Name and details of the medical devices under the scope of GMP audit and certification
  • Name of the person or representative designated by the manufacturer for communicating the technical documentation of the manufacturing line
  • Summary of the Quality Management System (QMS), including the qualification and validation details
  • Site Master File, plans, layouts, drawings of the manufacturing establishment (facility)
  • Organization chart including all the functions and depicting the reporting structure
  • Description and block diagram of the manufacturing process of the device
  • Name and address of the manufacturing establishment (facility) involved in each manufacturing stage of medical device
  • Description of individual manufacturing stage carried out in each of the manufacturing establishment (facility)

Mexico, being the second-biggest medical device market in LATAM, offers a promising opportunity to device manufacturers. The major barrier to tap the market potential is the language, as the regulations are not available in English. Given this huge gap in understanding the requirements of COFEPRIS, manufacturers rely on Regulatory service providers for Mexican market access. Consult a proven Regulatory expert today. 

For more information on the QMS requirements for device compliance in Mexico, kindly reach out to a proven Regulatory expert today. Stay informed. Stay compliant.

 

Category: