The healthcare sector, being a dynamic and rapidly developing industry, relies heavily on medical devices to support diagnosis, treatment, and patient care. With its position as the second-largest medical device market in Latin America, Mexico presents a lucrative opportunity for manufacturers in the IVD and medical device industry.
Let’s explore the rules and guidelines governing medical devices in Mexico.
Medical Device Regulatory Authority In Mexico:
The regulatory body overseeing medical devices in Mexico is the Federal Commission for Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). COFEPRIS’s primary responsibilities entail evaluating medical devices to ascertain they meet the required standards, promoting public health and ensuring the safety of patients.
Product Classification with Examples:
as per Mexico (COFEPRIS) Regulations for Medical Device Registration
– Medical devices in Mexico are classified into four risk classes: Class I, Class IIa, Class IIb, and Class III, based on their associated potential risk.
– Class I devices are non-invasive and have low risk, examples include elastic bandages, crutches, and non-powered surgical instruments.
– Class IIa devices are low to medium-risk and include non-invasive diagnostic devices like thermometers and blood pressure monitors.
– Class IIb devices are medium to high-risk, such as powered medical instruments and certain implantable devices.
– Class III devices are high-risk, including implantable cardiac pacemakers and heart valves.
– Medical device labeling in Mexico must be in Spanish and should include essential information.
Explore how Artixio supports medical device companies with regulatory affairs and compliance services in Mexico.
Medical Device Clinical Trial Requirements:
In Mexico, clinical trials for medical devices are mandated for specific high-risk devices (Class III) and novel technologies. These trials must comply with national regulations and guidelines in terms of their design and ethical considerations. To initiate the approval process, researchers are required to submit a comprehensive research protocol to COFEPRIS for thorough evaluation and authorization. This ensures that the trials adhere to the established standards and safeguards in place.
Testing Requirements:
When it comes to medical devices intended for use in Mexico, they must meet precise technical requirements and adhere to rigorous safety standards. To demonstrate compliance with the regulations set by Mexican authorities, manufacturers are obligated to conduct testing. While third-party testing is allowed, it is important to note that the testing laboratories must be accredited and recognized by the Mexican authorities.
Foreign Testing and Applicability:
In some cases, foreign testing data can be utilized to support medical device registration in Mexico, especially if conducted in recognized international labs. However, it is crucial to verify the acceptance of foreign testing data on a case-by-case basis.
Pre-registration Requirements:
Prior to submitting the registration application, manufacturers are required to obtain a COFEPRIS sanitation license. This license serves as confirmation that the manufacturing facilities adhere to good manufacturing practices (GMP) and comply with quality standards.
Medical Device Registration Process In Mexico:
The registration process for medical devices in Mexico consists of the following steps:
a. Submission of the registration application and necessary documents, including technical information, labeling, and proof of compliance with Mexican standards.
b. COFEPRIS conducts a review and evaluation, which may include a technical assessment and inspection of the manufacturing facilities.
c. Upon successful completion of the evaluation, the registration certificate is approved and issued.
Approval in EU/US and its Impact on Registration:
Medical devices that have already obtained approval in either the European Union (EU) or the United States (US) can benefit from an expedited registration process in Mexico. The Mexican regulatory authority, COFEPRIS, acknowledges the rigorous standards of these well-regulated markets and may take into account their approvals during the evaluation. This recognition can potentially streamline the registration timeline for the medical device, offering a more efficient path to market entry in Mexico.
Import and Distribution Requirements:
To import and distribute medical devices in Mexico, entities must possess a valid importation and distribution license issued by COFEPRIS. Additionally, they must comply with all labelling and packaging regulations.
List of Documents Required in Each Module:
The documents needed for medical device registration vary based on classification and risk level. However, common requirements include technical details, quality management system certificates (ISO 13485), clinical evidence, labelling, manufacturing facility information, and GMP compliance.
GMP Inspection Requirements:
To register medical devices in Mexico, manufacturers must meet COFEPRIS’s Good Manufacturing Practices (GMP). Inspections may be conducted on manufacturing facilities to confirm compliance with GMP standards.
Timeline and Associated Fees:
The timeline for medical device registration in Mexico can vary depending on the device class and complexity. Standard Route typically takes 3-6 months, Expedited Route (Third Party Route-TPR) takes 2-5 months, and Equivalency Route (for US, Canada, and Japan-approved devices) takes 3-8 months. The registration fees for medical devices and in-vitro diagnostic (IVD) devices vary based on their classification. For Class I MD/IVD devices, the registration fee is $650 USD. Class II MD/IVD devices have a registration fee of $1,000 USD, while Class III MD/IVD devices require a registration fee of $1,250 USD.
Post-Marketing Activities:
Medical device manufacturers are entrusted with ongoing responsibilities following the registration and approval of their products. These include:
1. Pharmacovigilance: Manufacturers are required to actively monitor and promptly report any adverse events or negative effects associated with the use of their devices. This enables the identification and addressing of potential risks to ensure the continued safety and effectiveness of the devices.
2. Variations: Any modifications or changes to the device’s design, labelling, or manufacturing process must be communicated to COFEPRIS, the regulatory authority in Mexico. This ensures that these changes are evaluated for compliance and safety considerations to maintain the quality of the devices.
3. Renewal: Registration certificates for medical devices typically have a limited validity period. Therefore, manufacturers must ensure the timely renewal of these certificates to continue legally marketing and selling their devices in Mexico.
4. Audits: COFEPRIS has the authority to conduct post-market audits to assess manufacturers’ compliance with regulations and standards. These audits serve as an important evaluation tool to verify that manufacturers are adhering to the necessary requirements and maintaining the desired quality and safety standards.
COFERIS QMS compliance Requirements under NOM-241-SSA1-2021
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)
- ISO 13485:2016
- 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.
Understanding COFEPRIS requirements is essential for medical device market access in Mexico. Learn how Artixio assists manufacturers with regulatory strategy, registration, and post-market compliance. Talk to us at info@artixio.com
Here are answers to some of the Frequently Asked Questions about Mexico regulations for Medical Device registration.
FAQs – Mexico (COFEPRIS) Regulations for Medical Device Registration
What is the regulatory authority responsible for medical device registration in Mexico?
The authority responsible for governing the regulations for medical device registration and quality control in Mexico is COFEPRIS (Federal Commission for Protection against Sanitary Risks)
What are the steps involved in the registration process of medical device in Mexico as per COFEPRIS regulations?
Step 1: Determine Classification: Determine the classification of your medical device according to the risk-based classification system established by COFEPRIS. The classification will determine the regulatory requirements and the specific documentation needed for registration.
Step 2:
- Prepare Documentation: Prepare the required documentation, which may include:
- Manufacturer information: Name, address, and contact details of the manufacturer.
- Device description: Detailed description of the device, including its intended use, indications, and specifications.
- Technical documentation: Technical specifications, design drawings, manufacturing processes, and quality control information.
- Clinical data: Clinical evidence, such as clinical studies, performance evaluations, or literature reviews, supporting the safety and efficacy of the device.
- Labeling and Instructions for Use (IFU): Translated labeling and IFU in Spanish, including product labeling, package inserts, and user manuals.
- Quality management system: Documentation demonstrating compliance with relevant quality management system standards, such as ISO 13485.
- Regulatory documents: Copies of certificates or authorizations from regulatory authorities in other countries where the device is already registered.
Step 3: Appoint an Authorized Representative: If you are a foreign manufacturer, appoint an authorized representative in Mexico who will act as a liaison with COFEPRIS and fulfill the local representation requirements.
Step 4: Submit Application: Prepare and submit the application for registration to COFEPRIS. The application should include all the required documentation, completed forms, and any applicable fees. Ensure that the application is accurate and complete to avoid processing delays.
Step 5: Review and Evaluation: COFEPRIS will review the submitted documentation and evaluate the compliance of the device with regulatory requirements. This process may involve an assessment of the technical, clinical, and quality aspects of the device. The evaluation timeline can vary depending on the device classification and the workload of the regulatory authority.
Step 6: Inspections and Audits: COFEPRIS may conduct inspections or audits of the manufacturing facilities to verify compliance with quality and safety standards. These inspections can be scheduled as part of the evaluation process or conducted on a random basis.
Step 7: Approval and Certificate Issuance: If the device meets all the requirements and passes the evaluation, COFEPRIS will issue a registration certificate. This certificate allows the device to be legally marketed and sold in Mexico.
Step 8: Post-Market Surveillance: After registration, manufacturers are responsible for post-market surveillance, including monitoring the safety and performance of the device, handling any adverse events or complaints, and complying with reporting obligations.
It’s important to note that the registration process and requirements can vary based on the specific device and its classification. It is advisable to consult with Artixio’s regulatory experts familiar with the Mexican regulatory system to ensure compliance with the latest requirements.
Are there any specific labeling or packaging requirements for medical devices in Mexico as per COFEPRIS regulations?
Here are some key aspects of the labeling and packaging requirements:
- Labeling Language: All labeling and instructions for use (IFU) must be in Spanish. It is important to ensure accurate translation and use of appropriate terminology for the Mexican market.
- Device Identification: The labeling should include the following information:
- Device name or trade name
- Manufacturer’s name and address
- Device model or catalog number
- Batch or lot number (if applicable)
- Manufacturing and expiration dates (if applicable)
- Unique device identifier (UDI) or product code (if required)
3. Instructions for Use (IFU): The labeling should include clear and comprehensive instructions for the safe and proper use of the device. The IFU should cover topics such as device preparation, operation, storage, maintenance, and disposal.
4. Warning and Caution Statements: Appropriate warning and caution statements should be included on the labeling to alert users to potential risks or precautions associated with device use.
5. Symbols and Graphical Representations: If symbols or graphical representations are used on the labeling, they should conform to the international standards and be accompanied by a clear explanation of their meaning.
6. Contraindications and Indications for Use: The labeling should clearly state any contraindications, warnings, or limitations on device use. It should also specify the intended indications for use.
7. Packaging: The packaging of medical devices should provide adequate protection during transportation and storage. It should be designed to maintain the sterility, integrity, and functionality of the device until it reaches the end-user.
8. Labeling Changes: Any changes to the labeling or packaging after registration should be communicated to COFEPRIS and, if necessary, undergo an approval process.
Are clinical trials or testing necessary for registration? If so, what are the requirements?
Clinical trials or testing may be necessary for medical device registration in Mexico, depending on the risk classification and the specific characteristics of the device. The requirements for clinical trials or testing can vary, and it is essential to determine the specific requirements applicable to your device classification. Here is an overview of the general considerations:
- Risk Classification: The risk classification system in Mexico categorizes medical devices into four classes (I, II, III, and IV) based on the potential risk they pose to patients and users. Higher-risk devices, such as implantable devices or devices used for life-supporting purposes, generally have more stringent requirements for clinical data.
- Clinical Data Requirements: COFEPRIS may require clinical data to support the safety and efficacy of medical devices, particularly for higher-risk devices (Class II, III, and IV). The clinical data should demonstrate that the device performs as intended and meets the relevant safety and performance standards.
- Type of Clinical Data: The type of clinical data required can vary. It may involve conducting clinical trials, collecting data from post-market surveillance studies, or providing evidence from existing clinical literature and published studies. The specific requirements will depend on the device classification and the level of clinical evidence already available.
- Clinical Trial Approval: If clinical trials are necessary, the study protocol and design must be submitted for review and approval by an authorized ethics committee in Mexico. The ethics committee evaluates the scientific validity, ethical considerations, and patient safety aspects of the proposed clinical trial.
- Good Clinical Practice (GCP): If clinical trials are conducted, they must adhere to Good Clinical Practice (GCP) guidelines, which ensure the ethical and scientific integrity of the study. Compliance with GCP includes proper study design, informed consent procedures, data management, monitoring, and reporting.
- Clinical Evaluation Report: A comprehensive clinical evaluation report should be prepared, summarizing the clinical data and its analysis. The report should provide a critical assessment of the device’s safety and performance, considering relevant clinical literature, clinical trials, and post-market surveillance data.
What are the fees associated with the registration process?
- Application Fee: There is usually an application fee that must be paid when submitting the registration application. The fee amount can vary based on the device classification and the complexity of the registration process.
- Evaluation Fee: COFEPRIS may charge an evaluation fee for reviewing the registration application and assessing the compliance of the device with regulatory requirements. The evaluation fee can vary depending on the type and complexity of the device.
- Modification Fee: If modifications or changes are made to the registration application after submission, COFEPRIS may require a modification fee for reviewing and processing those changes.
- Renewal Fee: Registration certificates for medical devices in Mexico typically have a validity period. To renew the registration, a renewal fee is usually required. The renewal fee amount can vary depending on the device classification and the renewal period.
- Additional Fees: There may be additional fees associated with specific services or processes related to the registration, such as labeling review, facility inspections, or expedited processing requests. These fees will be determined by COFEPRIS based on the specific service requested.
Is it necessary to have a local authorized representative in Mexico for registration?
Yes, it is generally necessary to have a local authorized representative in Mexico for medical device registration. The authorized representative serves as the local point of contact between the foreign manufacturer and the regulatory authorities in Mexico, such as COFEPRIS. The role of the authorized representative includes submitting the registration application on behalf of the manufacturer and fulfilling other legal obligations related to the medical device registration process.
Having a local authorized representative is a regulatory requirement in Mexico for foreign manufacturers who do not have a physical presence in the country. The authorized representative must be a legally registered entity in Mexico and should be capable of fulfilling the responsibilities associated with the role. This includes ensuring compliance with regulatory requirements, responding to inquiries or requests for information from COFEPRIS, and acting as the liaison between the manufacturer and the regulatory authorities.
The authorized representative is responsible for handling the administrative and regulatory aspects of the registration process, facilitating communication, and ensuring that the necessary documentation and information are provided to COFEPRIS in the appropriate format and within the required timelines.
Are there any post-registration obligations or reporting requirements?
Here are some common post-registration obligations and reporting requirements:
Adverse Event Reporting: Manufacturers and authorized representatives are required to report any adverse events or incidents related to the use of their medical devices to COFEPRIS. Adverse events include any undesirable or unexpected effects, malfunctions, or incidents that result in harm or potential harm to patients, users, or others. Timely reporting of adverse events is crucial for monitoring device safety and taking appropriate actions, such as product recalls or safety alerts if necessary.
Field Safety Corrective Actions (Recalls): In the event of a safety issue or defect with a medical device, manufacturers and authorized representatives may need to initiate field safety corrective actions, such as recalls or product corrections. COFEPRIS should be informed of such actions, and appropriate measures should be taken to ensure that affected devices are removed from the market or corrected to prevent harm to patients or users.
Periodic Safety Updates: Manufacturers and authorized representatives are often required to provide periodic safety updates to COFEPRIS. These updates include information on any new safety concerns, changes in risk-benefit profiles, updates to labeling or instructions for use, or significant changes in the manufacturing process. Periodic safety updates help to ensure ongoing assessment of the device’s safety and effectiveness in the market.
Post-Market Surveillance: Manufacturers and authorized representatives are responsible for implementing post-market surveillance activities to monitor the performance, safety, and effectiveness of their medical devices. This may involve collecting and analyzing data from various sources, such as adverse event reports, clinical studies, user feedback, and scientific literature. The findings from post-market surveillance activities should be used to continuously assess and improve the device’s safety and performance.
Labeling and Product Information Updates: Manufacturers and authorized representatives should ensure that the labeling and product information remain up-to-date and in compliance with regulatory requirements. Any changes to the labeling or instructions for use should be communicated to COFEPRIS as required.
Are there any exemptions or expedited processes available for certain types of medical devices?
Low-Risk Devices: COFEPRIS may offer expedited registration processes or simplified requirements for medical devices that are classified as low-risk. These devices typically have a lower potential for harm and may include certain non-invasive or non-implantable devices.
Equivalent Device Recognition: COFEPRIS may accept the registration of a medical device that has already been authorized by a trusted regulatory authority in another country. This process, known as equivalent device recognition, allows for a faster registration process by leveraging existing regulatory assessments and certifications.
Harmonization with International Standards: COFEPRIS aligns its regulatory requirements with international standards and guidelines. For medical devices that comply with these recognized standards, there may be expedited processes or exemptions available, as the conformity to international standards can demonstrate safety and efficacy.
Emergency Use or Public Health Needs: In certain urgent situations, such as public health emergencies or national crises, COFEPRIS may establish expedited processes to allow the importation or use of medical devices to address critical healthcare needs. These processes prioritize timely access to devices that can contribute to patient care and public health.
Are there any unique considerations or requirements for software or digital health applications?
Yes, there are unique considerations and requirements for software or digital health applications by COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico. The regulatory landscape for software and digital health applications is evolving to address the rapid advancements in technology and the growing use of digital solutions in healthcare. Here are some key considerations:
Software as a Medical Device (SaMD): COFEPRIS recognizes that certain software or digital health applications can be classified as medical devices if they are intended for medical purposes and have a direct impact on patient diagnosis, treatment, or monitoring. SaMD is subject to the same regulatory requirements as other medical devices, including registration, quality control, and post-market surveillance.
Risk Classification: COFEPRIS classifies software or digital health applications based on their risk level, similar to other medical devices. The risk classification determines the specific regulatory requirements and documentation needed for registration. Higher-risk applications, such as those involving diagnosis or treatment decisions, may require more extensive clinical data or evidence of performance and safety.
Technical Requirements: COFEPRIS expects software and digital health applications to meet certain technical requirements, such as reliability, security, data protection, and interoperability. These requirements are aimed at ensuring patient safety, data privacy, and the proper functioning of the software.
Clinical Validation and Performance Evaluation: COFEPRIS may require clinical validation and performance evaluation for software or digital health applications, particularly for higher-risk applications. This involves providing clinical data or evidence demonstrating the safety, efficacy, and performance of the software in its intended use.
Quality Management Systems: Manufacturers or developers of software or digital health applications should establish and maintain a quality management system (QMS) in line with relevant standards, such as ISO 13485. The QMS should cover software development processes, risk management, and post-market surveillance activities.
Cybersecurity and Data Privacy: COFEPRIS emphasizes the importance of cybersecurity and data privacy for software and digital health applications. Manufacturers and developers should implement appropriate measures to protect patient data, ensure secure communication, and mitigate potential cybersecurity risks.
Post-Market Surveillance: Post-market surveillance activities, such as monitoring adverse events, user feedback, and software updates, are important for software and digital health applications. Manufacturers and developers should have mechanisms in place to monitor the performance, safety, and effectiveness of their applications after they are on the market.
Are there any local standards or additional testing requirements beyond international standards?
NOM (Official Mexican Standard): NOMs are technical standards established by the Mexican government to regulate various products, including medical devices. While many NOMs are harmonized with international standards, there may be specific NOMs that apply to certain types of medical devices, especially for devices used in specific healthcare fields or sectors.
Mexican Pharmacopeia: For medical devices that include pharmaceutical components or substances, the Mexican Pharmacopeia may apply. It provides standards for quality control, purity, and identification of pharmaceutical substances, as well as guidelines for pharmaceutical formulation and testing.
Local Testing Requirements: COFEPRIS may request additional testing or verification of specific parameters beyond the internationally recognized standards for certain medical devices. These additional tests or requirements can be specific to the Mexican market or based on local healthcare needs or considerations.
Can I use a foreign clinical study or data for registration purposes?
Acceptance of Foreign Clinical Study Data: COFEPRIS generally accepts foreign clinical study data (from reference countries) as part of the registration dossier for medical devices in Mexico. This data can be used to support the safety, efficacy, and performance claims of the device.
Relevance and Applicability: The foreign clinical study data should be relevant and applicable to the Mexican population and healthcare context. COFEPRIS will assess whether the study data can provide meaningful evidence of the device’s safety and effectiveness for the intended use in Mexico.
Regulatory Harmonization: COFEPRIS aims to align its regulatory requirements with international standards and guidelines. Therefore, clinical study data generated in compliance with recognized international standards, such as ISO 14155 for clinical investigations, are generally considered acceptable.
Language and Documentation: The foreign clinical study data should be translated into Spanish, as COFEPRIS requires all documentation to be in Spanish. It is important to accurately translate the study data to ensure its comprehension and evaluation by the regulatory authorities.
Regulatory Expertise: It can be beneficial to engage regulatory experts or consultants familiar with the Mexican regulatory system. They can assist in evaluating the relevance and applicability of foreign clinical study data, ensuring compliance with documentation requirements, and effectively communicating the data to COFEPRIS.
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