Mexico, a thriving and expanding market for medical devices, presents its distinct regulatory framework that manufacturers must adeptly navigate to introduce their medical devices into the country's healthcare system. Oversight of medical devices in Mexico falls under the jurisdiction of the Secretariat of Health (Secretaría de Salud). In compliance with the Mexican General Health Law, every medical device must undergo registration with the Secretariat of Health before it can be made available within Mexico. Facilitating this process is the Federal Commission for Protection of Sanitary Risks (COFEPRIS), responsible for overseeing the registration of medical devices.
The Regulatory framework is comprised of obligatory standards, referred to as Normas Oficiales Mexicanas (NOM), and non-mandatory standards, known as Normas Mexicanas (NMX). Medical device manufacturers should pay special attention to NOM-241-SSA1-2021, a pivotal regulation governing the establishment and enforcement of the quality management system for medical devices, as stipulated by COFEPRIS.
NOM-241-SSA1-2021 is an integral component of the comprehensive legal framework governing medical devices in Mexico, playing a pivotal role in guaranteeing the safety, effectiveness, and quality of these products. The most recent iteration of the Mexican Official Standard, NOM-241-SSA1-2021, which addresses Good Manufacturing Practices for Medical Devices (referred to as NOM-241 hereafter), was officially released on December 20, 2021, and became enforceable on June 20, 2023. This updated regulation aligns with international standards and best practices for medical devices, taking into consideration:
International Medical Device Regulators Forum (IMDRF)
EU Medical Devices Regulation 2017/745 (MDR)
The Medical Device Single Audit Program (MDSAP)
These harmonization with global standards enhance the quality and regulatory compliance of medical devices produced and marketed in Mexico.
What's New in Comparison to NOM 2012?
The most recent iteration of the NOM-241 standard introduces novel concepts and enhances the clarity of definitions, offering a more comprehensive understanding when compared to the 2012 version. These revisions are in harmony with the recent release of the 5.0 Supplement for Medical Devices in the Mexican Pharmacopoeia. Additionally, they align with the latest amendments to the General Health Law. Some of the fresh and modified concepts now encompass:
Good practices for storage and distribution
Adherence to Good Laboratory Practices
Introduction of the Certificate of Compliance
An updated medical device definition, now including Software as a Medical Device (SaMD)
Incorporation of Quality Risk Management
Guidelines for the refurbishing of medical devices
Regulations for the remanufacturing of medical devices
Introduction of an Annual Product Review (APR) and Annual Quality Review (AQR) of products
Clarification of the role of the Registration Holder
In addition to the existing requirements laid out in the 2012 version of NOM-241, the updated Quality Management System (QMS) requirements now necessitate addressing the following areas:
Monitoring and measurement of the product.
The integration of risk management protocols.
Key highlights of NOM-241-SSA1-2021
The revised standard places a strong emphasis on the necessity for a comprehensive Quality Management System (QMS) that covers every facet of a medical device's journey – starting from its design and development, through manufacturing, distribution, and continuing with post-market surveillance. All facilities engaged in the production, packaging, storage, and distribution (within the supply chain) of medical devices within Mexican borders must adhere to these Good Manufacturing Practices (GMP) guidelines.
It's imperative that each manufacturing site where a medical device is produced possesses a valid GMP certification. This requirement remains consistent across all medical devices, regardless of their risk classification, the scale of the manufacturing facility, or the specific product. NOM-241 provides detailed guidance on meeting COFEPRIS' expectations pertaining to the organization of the establishment, personnel requirements, documentation, facility standards, production control, equipment usage, procedures for product recalls, validation processes, audit protocols, and various other prerequisites essential for compliance.
COFEPRIS, acting on behalf of the Ministry of Health (MoH), holds the responsibility of overseeing and ensuring that medical device manufacturers strictly adhere to the Good Manufacturing Practices (GMP) standards mandated by NOM-241. In cases where a compliance assessment is warranted, the Sanitary Responsible Person and Legal representative have the authority to initiate this process by formally requesting it from COFEPRIS. To initiate the assessment, the involved stakeholders must complete an application form and furnish the necessary documentation pertaining to the Quality Management System (QMS) for medical devices.
Crucial QMS Compliance Obligations cross the Supply Chain under NOM-241-SSA1-2021
The primary actors within the Medical Devices supply chain system in Mexico encompass:
Contract Manufacturers situated within Mexico
Sanitary Registration Holders
It is plausible for scenarios to occur where the Sanitary Registration Holder takes on multiple roles, functioning as a manufacturer, importer, or distributor. In certain cases, distributors themselves might engage in the importation of medical devices. In such complex scenarios, these stakeholders are obliged to adhere to the specific QMS obligations related to each of their respective roles.
In a broad sense, all the stakeholders listed above are mandated to ensure that their Quality Management Systems encompass procedures for:
The development of a Quality Manual
Establishing an auditing system for self-inspection
Effective management of complaints
Handling procedures for non-conforming products
Corrective and Preventive Action (CAPA) management
Ensuring proper facilities and equipment management
Efficient waste management
These QMS procedures are vital to maintaining quality, safety, and regulatory compliance throughout the entire supply chain.
Procedures for Design and Development
Manufacturers, including contract manufacturers, must implement procedures for the design and development of medical devices. This includes the Validation Master Plan (VMP), qualification and validation processes, and the transfer of manufacturing systems and technology. When the final medical device is contract-manufactured at a facility within Mexico and is intended for the Mexican market, the Registration Holder is responsible for ensuring that procedures for technology transfer are incorporated into their QMS systems.
Quality Control Protocols
Manufacturers are obligated to have established quality control procedures. For imported condoms, importers must also have in place quality control procedures, as every batch of imported condoms undergoes mandatory laboratory testing, either at a Third Party Laboratory Testing facility or at the importer's laboratory.
Compliance with Good Distribution Practices
Manufacturers, which includes contract manufacturers, importers, and distributors, are required to adhere to Good Distribution Practices (GDP) as a fundamental component of their Quality Management System procedures. If the importer or distributor is simultaneously acting as the registration holder, they must additionally establish QMS procedures to ensure compliance with GDP.
In the case of outsourced activities, it is imperative that all such activities are meticulously documented through formal agreements, particularly when the manufacturer and the registration holder are distinct entities. If the manufacturer and registration holder are separate entities, the registration holder must institute procedures for managing outsourced activities.
Other QMS Requirements
*In case the manufacturer is not the Sanitary Registration Holder, the registration holder is responsible for adverse incidents reporting and must also ensure that manufacturer is also communicated of the same for consideration in risk management.
#in cases where Sanitary Registration Holder is the the manufacturer, importer, and/or distributor
Recognition of Alternative Quality Management System (QMS) Certifications by COFEPRIS
As specified in clause 6.7 of the NOM-241 Standard, the Foreign manufacturers typically furnish ISO 13485 certifications or GMP certificates issued by their Ministry of Health to support sanitary registration, as these are regarded as equivalent to the Quality Management System described in NOM-241.
In the recent times, COFEPRIS has announced that
The Health Authorization Commission will acknowledge MDSAP certification as equivalent to GMP certification issued by COFEPRIS for
new sanitary registrations, modifications, and renewals of medical devices produced in Mexico.
MDSAP certification will also be recognized as valid for supporting sanitary registrations, modifications, and renewals of medical devices produced abroad.
While COFEPRIS has previously accepted MDSAP and ISO certificates from foreign manufacturers, this announcement now formalizes it as official policy. Once implemented, this will bring substantial benefits to manufacturers based in Mexico, as they will be able to use MDSAP and ISO 13485 compliance to fulfill the requirements of NOM-241.
The compliance with COFEPRIS QMS requirements under NOM-241-SSA1-2021 is essential for medical device manufacturers seeking to enter the Mexican market. While the process may be challenging, it's a critical investment in ensuring the safety and efficacy of your devices and accessing a promising market. By partnering with experts and diligently adhering to the regulation, manufacturers can successfully navigate the regulatory landscape and bring their innovative medical devices to patients in Mexico.
Ready to navigate the complexities of NOM-241-SSA1-2021 and gain access to the thriving Mexican market for medical devices? Our team of regulatory experts is here to guide you through the compliance process, from QMS development to documentation and reporting. Contact us today to start your journey toward successful market entry in Mexico and make patient safety your top priority. Let's work together to ensure your medical devices reach those in need while adhering to all regulatory requirements.