Author: DANIEL VILLENA

Which are the new low-risk devices that require marketing au- thorisation and which are no longer considered health supplies in Mexico? What does the medical device sector needs to know?

Post author By DANIEL VILLENA
Post date 20 November, 2025

On July 7th, 2025, an agreement was published that brings important changes to medical devices in Mexico. This new document, which came into effect on July 8th, 2025, seeks to update the list of supplies and products considered low-risk and those not, in accordance with technological advances since the last publication (December 2014) to date.

The main objective of this update is to establish and make known clear lists of medi- cal devices that, due to their low risk, require or do not require marketing authorisa- tion. It also seeks to streamline the process of obtaining these authorisations and facilitate the gradual regulation of products that were previously unregulated. This agreement updates and replaces previous publications from 2011 and 2014.

Key Novelties of the Agreement

One of the most notable changes is the way devices are classified. Previously, there were only two categories (low-risk supplies requiring registration, and products not considered health supplies); now, the agreement presents three main annexes:

 Annex 1: Low-risk medical devices that DO require marketing authorisation. Here are products such as orthodontic archwires, kinesiology tape, ear specula (reusable and disposable) sold separately for otoscopes, orthodontic face masks, N95 respirators, among others.

 Annex 2: Low risk medical devices that do NOT require marketing authorisation. This annex is new and now includes products that previously required registration or were not considered medical devices. For example, elastic shoulder immobilizers, diagnostic and examination lights, plastic mouth gags, stretchers, patient scales, wheelchairs (manual or motorized), among many others. Products such as compress warmers and multi-position hospital beds have been added.

 Annex 3: Products that are NOT considered health supplies and, therefore, DO NOT require marketing authorisation. This category includes items that, by their nature, do not have a direct medical purpose, such as cotton for cos- metic use, bags for biological-infectious hazardous waste (BIW), training mannequins, ambient air purifiers, unequipped office furniture, and software for monitoring performance of a medical device or for clinical research, among others.

Less Waiting Time for Formalities

The new agreement also seeks to reduce response times for applications for market- ing authorisation of low-risk devices.
The resolution time is reduced from 30 to 20 working days.
In addition, the timeframe for the authority to request additional information (preventions) is also adjusted:

For administrative requests: 10 working days remain.
For technical requests: 15 working days are reduced from 20 to 15 working days. The deadline for concerned parties to respond to these requests remains at 10 work- ing days, with no extension.–

Clearer Requirements for Authorisation

Requirements for authorisation vary depending on the device classification:

For devices listed in Annex 1 (which do require registration): An Aviso de Funcionamiento issued by Cofepris, application form, labelling Project, instruction manuals, technical information, and payment of COFEPRIS FEE. If the product manufactured abroad, representation letter issued by the legal manufacturer is also required.

For devices listed in Annex 2 (which do not require registration): Only a Aviso de Funcionamiento issued by Cofepris and a sanitary responsible approval are required. An importation permit is not required, but a declaration must be submitted to cus- toms certifying that the product complies with good manufacturing practices and technovigilance.

For products listed in Annex 3 (which are not health supplies): These products are not subject to marketing authorisation or importation permits.

Goodbye to Exceptional and Gradual Regularization Official Letters

A crucial point is that the facilities that currently have an official letter for exception and are now listed in Annex 1 must carry out the formality for their marketing au- thorisation within an established timeframe that runs from 2025 to 2029.

– From 1 to 38, entry 2025 to 2026
– From 39 to 75, entry 2026 to 2027
– From 76 to 116, entry 2027 to 2028
– Outside these years, maximum deferral until 2029

Five years after the entry into force of this agreement, all exemptions will cease to apply. However, if a registration application for a product with an exemption is pend- ing, it remains valid until the authority issues a decision.

This new agreement represents a significant effort to modernize and streamline the regulation of medical devices in the country, which will facilitate access to essential health products and ensure their safety.

D:\PETNORMA\rafconsulting\Acuer

Source:
AGREEMENT TO PROVIDE ANNOUNCEMENT OF LISTS OF MEDICAL DEVICES CONSIDERED LOW RISK THAT REQUIRE MAR- KETING AUTHORISATION, THOSE THAT DO NOT REQUIRE MARKETING AUTHORISATION, AND THOSE PRODUCTS THAT, DUE TO THEIR NATURE, CHARACTERISTICS AND USE, ARE NOT CONSIDERED HEALTH SUPPLIES AND THEREFORE DO NOT REQUIRE MARKETING AUTHORISATION

Accreditations

RAF Consulting – Navigating Mexico’s Regulatory Landscape with Expertise and Precision

Post author By DANIEL VILLENA
Post date 15 September, 2025

Breaking into Mexico’s healthcare market is no small feat. For international manufacturers, Mexico’s COFEPRIS— Federal Commission for the Protection against Sanitary Risk—regulations are a moving target. The evolving regulations and shifting requirements routinely slow approvals and disrupt timelines.

RAF Consulting makes the process seamless. Founded by Gloria Frías, an expert of multinational pharma, the firm brings over two decades of experience helping companies not just meet compliance, but accelerate entry and growth. RAF Consulting delivers more than regulatory filings; it offers strategic guidance, local insight, and hands-on navigation of every step, from strategic planning, product registration to market launch, and support during all product life cycle.

“For manufacturers eyeing Mexico, RAF Consulting isn’t just a consultant, it’s the difference between getting stuck in the process and getting to market fast,” says Frias, CEO and founder. Its deep knowledge of COFEPRIS regulations and criteria gives the company a natural edge in tailoring regulatory strategies that befit clients’ specific needs. RAF Consulting’s offerings include regulatory intelligence and strategy, which are critical for companies looking to enter the Mexican market. This service covers everything from product classification and regulatory pathways to risk assessment, ensuring that clients are well-prepared and positioned for success.

In addition to this strategic support, RAF Consulting provides extensive dossier preparation and submission services, covering a broad spectrum of products including pharmaceuticals (biotech, generics, new drugs, and herbal products, among others), medical devices, food supplements, and cosmetics. By managing all aspects of the regulatory submission process, the firm helps companies streamline their efforts and avoid the common pitfalls that often lead to delays or rejections.

A notable strength of RAF Consulting is its ability to act as a registration holder for medical devices. The firm currently holds over 150 registrations for about 30 companies worldwide, providing foreign manufacturers with a reliable and independent partner with no commercial ties to product sales, ensuring full regulatory focus and impartiality. This is a crucial service for companies that want to maintain focus on their core business operations without being bogged down by the intricacies of regulatory or conflict of interest obstacles.

RAF Consulting also provides legal representation for pharmaceutical products in Mexico. While the GMP-compliant manufacturer holds the registration, it manages all aspects of the registration process and regulatory responsibility, and ensures continued compliance with Mexican regulations. This is particularly valuable for companies seeking a reliable partner that complies with the infrastructure required, so they need not establish their own and focus on their global operations.

Since being authorized by COFEPRIS in 2013, RAF Consulting has played a key role in pharmacovigilance and technovigilance. The firm manages adverse event reporting, periodic safety update reports (PSURs), and compliance audits, ensuring that companies meet all mandatory Mexican reporting requirements. With licenses from MedDRA and WHODrug, RAF Consulting remains at the forefront of ensuring that clients meet all safety and vigilance standards.

One of the company’s most impressive capabilities is its ability to offer regulatory lifecycle support, which includes variations, renewals, labeling, and advertising compliance. This ongoing support ensures that clients’ products remain in full compliance throughout their entire lifecycle in the Mexican market.

RAF Consulting’s commitment to keeping its clients informed about the latest regulatory changes is another reason why it is highly valued by its clients. The company’s team continuously monitors regulatory updates, integrating them into their processes in real time. This proactive approach ensures that clients remain compliant, even as the regulatory landscape evolves. Raf consulting has already integrated recent regulation updates, like the new equivalence agreement that marks the start of Mexican regulation towards Reliance.

Read Article

Medical devices

New agreement on the listing of medical devices

Post author By DANIEL VILLENA
Post date 19 August, 2025

On July 7^th, 2025, an agreement was published that brings important changes to medical devices in Mexico. This new document, which came into effect on July 8^th, 2025, seeks to update the list of supplies and products considered low-risk and those not, in accordance with technological advances since the last publication (December 2014) to date.

The main objective of this update is to establish and make known clear lists of medi- cal devices that, due to their low risk, require or do not require marketing authorization. It also seeks to streamline the process of obtaining these authorizations and facilitate the gradual regulation of products that were previously unregulated. This agreement updates and replaces previous publications from 2011 and 2014.

Key Novelties of the Agreement

Annex 1: Low-risk medical devices that DO require marketing authorization. Here are products such as orthodontic archwires, kinesiology tape, ear specula (reusable and disposable) sold separately for otoscopes, orthodontic face masks, N95 respirators, among others.
Annex 2: Low-risk medical devices that do NOT require marketing authorization. This annex is new and now includes products that previously required registration or were not considered medical devices. For example, elastic shoulder immobilizers, diagnostic and examination lights, plastic mouth gags, stretchers, patient scales, wheelchairs (manual or motorized), among many others. Products such as compress warmers and multi-position hospital beds have been added.
Annex 3: Products that are NOT considered health supplies and, therefore, DO NOT require marketing authorization. This category includes items that, by their nature, do not have a direct medical purpose, such as cotton for cosmetic use, bags for biological-infectious hazardous waste (BIW), training mannequins, ambient air purifiers, unequipped office furniture, and software for monitoring performance of a medical device or for clinical research, among others.

Less Waiting Time for Formalities

The new agreement also seeks to reduce response times for applications for marketing authorization of low risk devices.

The resolution time is reduced from 30 to 20 working days.

In addition, the timeframe for the authority to request additional information (preventions) is also adjusted:

For administrative requests: 10 working days remain.

For technical requests: 15 working days are reduced from 20 to 15 working days. The deadline for concerned parties to respond to these requests remains at 10 working days, with no extension.

Clearer Requirements for Authorization

Requirements for authorization vary depending on the device classification:

For devices listed in Annex 1 (which do require registration): An Aviso de Funcionamiento issued by Cofepris, application form, labelling project, instruction manuals, technical information, and payment of COFEPRIS FEE. If the product manufactured abroad, representation letter issued by the legal manufacturer is also required.

For devices listed in Annex 2 (which do not require registration): Only a Aviso de Funcionamiento issued by Cofepris and a sanitary responsible approval are required. An importation permit is not required, but a declaration must be submitted to cus- toms certifying that the product complies with good manufacturing practices and technovigilance.

For products listed in Annex 3 (which are not health supplies): These products are not subject to marketing authorization or importation permits.

Goodbye to Exceptional and Gradual Regularization Official Letters

A crucial point is that the facilities that currently have an official letter for exception and are now listed in Annex 1 must carry out the formality for their marketing authorization within an established timeframe that runs from 2025 to 2029.

From 1 to 38, entry 2025 to 2026
From 39 to 75, entry 2026 to 2027
From 76 to 116, entry 2027 to 2028
Outside these years, maximum deferral until 2029

Five years after the entry into force of this agreement, all exemptions will cease to apply. However, if a registration application for a product with an exemption is pending, it remains valid until the authority issues a decision.

Source:

AGREEMENT TO PROVIDE ANNOUNCEMENT OF LISTS OF MEDICAL DEVICES CONSIDERED LOW RISK THAT REQUIRE MAR- KETING AUTHORIZATION, THOSE THAT DO NOT REQUIRE MARKETING AUTHORIZATION, AND THOSE PRODUCTS THAT, DUE TO THEIR NATURE, CHARACTERISTICS AND USE, ARE NOT CONSIDERED HEALTH SUPPLIES AND THEREFORE DO NOT REQUIRE MARKETING AUTHORIZATION.

Facilities

Medicine Warehouses: When is a Sanitary License required, and when is an Operating Notification needed?

Post author By DANIEL VILLENA
Post date 20 September, 2024

Modern pharmacy storage room and a robot hand is arranging and storing out drugs in a pharmacy.

Companies that distribute and market medicines for human use within national territory must have a warehouse to store the medicines they are authorized to hold, distribute, and/or sell. This warehouse must be duly registered and authorized by COFEPRIS.

Every time a warehouse for human-use medicines is established, the first step is to determine whether the warehouse requires an Operating Notification or a Sanitary License to start operations. This will be defined by the type of medicines that will be stored.

	Types of medicines that will be stored/distributed/marketed.
Sanitary License	Medicines containing narcotics (Section I) Medicines containing psychotropics (Sections II and III) Medicines containing toxoids, serums, animal-origin antitoxins Blood derivatives Vaccines Warehouses performing primary or secondary conditioning of medicines (any type)
Operating Notification	Medicines or biological products that do not contain narcotics and/or psychotropics, toxoids, serums, animal-origin antitoxins, blood derivatives, or vaccines (Sections IV, V, VI), such as: Allopathic medicines Vitamin medicines Herbal medicines Homeopathic medicines

It’s important to understand that an Operating Notification is not the same as a Sanitary License for a human-use medicine warehouse, and there are substantial differences in their application processes.

Operating Notification

An Operating Notification for a medicine warehouse, as its name implies, is a notification to the sanitary authority in which the company indicates that it will open a warehouse, providing the exact location, the start date of operations, and the activities to be carried out, for example, room temperature storage, room temperature transportation, distribution, etc.

To submit the Operating Notification, legal documents related to the company registering the warehouse are required (articles of incorporation, power of attorney, legal representative’s ID, among others), as well as the sanitary responsible’s credentials, such as their professional license, ID, etc. Since it is an electronic process, it must be signed by the concerned parties using the digital signature (e-signature) provided by the Tax Administration Service (SAT), and it must be submitted at least 30 days before operations start.

Filing an Operating Notification implies that the company is prepared for a potential inspection by the authority and already has a quality system in place as outlined in the Pharmacopeia Supplement for Warehouses of Sanitary Supplies.

Sanitary License

For warehouses that require a sanitary license, it is important to note that the warehouse cannot begin operations until the Sanitary License has been authorized.

The process is as follows:

First, a Sanitary Responsible Notification for the establishment is submitted.
A Sanitary License application is then submitted to Cofepris, specifying the operations to be carried out in the warehouse, the types of medicines to be handled, and the warehouse location. This Sanitary License application involves a verification visit to the warehouse facilities and infrastructure, as well as to the Quality Management System, which must be overseen by the sanitary responsible, who must be available on the inspection day, as indicated by NOM-059-SSA1-2015.
On the inspection day, the inspector will arrive with a verification order and identification, and the user can confirm if the inspector is registered with the Sanitary Operation Commission of COFEPRIS on the following page: https://www.gob.mx/cofepris/documentos/listado-de-verificadores-sanitarios-de-insumos-para-la-salud to avoid simulated inspections by fraudulent inspectors.
During the visit, the inspector will assess the Quality Management System, as well as compliance with NOM-059-SSA1-2015, and will record their evaluation in a verification report. After reviewing each point of the report, the inspector will inform the sanitary responsible of any observations.
Before signing the verification report with the inspection results, the company has the right to include comments or disagreements in the report, and it also has 5 business days after signing to submit any necessary information to COFEPRIS that may address any deviations.
COFEPRIS may issue a request for additional documents or information, and even request a follow-up inspection.
Once all issues have been satisfactorily resolved, COFEPRIS will authorize the Sanitary License.

Finally, it is important to note that, regardless of whether a warehouse requires an Operating Notification or a Sanitary License, it must have the appropriate facilities, infrastructure, and Quality Management System in accordance with the type of operations to be performed and the products to be stored (as established in NOM-059-SSA1-2015 and the Supplement for Establishments dedicated to the sale and supply of medicines and other sanitary supplies of the FEUM) before starting operations.

Based on all the above, the key is to clearly define the type of medicine to be stored and the activities to be carried out in the warehouse to determine the type of authorization needed to begin operations, if you have any question about this in Rafconsulting we will be glad to help you get your documents and your establishments in order.

Pharmacovigilance

Do you know how to report adverse drug reactions (ADRs) notifications?

Post author By DANIEL VILLENA
Post date 14 August, 2024

Megaphone icon with speech bubble in word adverse event on white background

Cofepris, in an attempt to encourage the reporting of adverse reactions by consumers and healthcare professionals, launched a new platform for notifications. This new platform is called VigiRam, which promises to be more user-friendly for the notifier and avoids discouraging the reporting process.

VigiRam is an application that can be installed on a mobile phone; it contains the complete electronic standardised format for reporting suspected adverse drug reactions. Notifications sent through this platform are encrypted and transmitted directly to the National Pharmacovigilance Center (CNFV).

VigiRam allows data/information capture without an internet connection, and it does not require users to register or create an account to use the tool; however, an internet connection is required to submit the captured information. It is important to mention that it allows sending notifications with the minimum required information. Each time a notification is sent, the application will confirm that the information was sent successfully and provides receipt acknowledgment.

This new method for reporting adverse reactions appears to be a more user-friendly tool compared to an email address or a phone call, which can take several minutes, and many people tend to avoid answering calls of uncertain duration.

The challenge now is to promote this tool among healthcare professionals and health institutions to encourage consumers to report adverse drug reactions in Mexico, which will help optimise drug safety.

You can download the information here:

Medical devices

The Medical Device Single Audit Program (MDSAP) in Mexico: A Revolutionary Initiative in Medical Device Regulation

Post author By DANIEL VILLENA
Post date 5 August, 2024

The Medical Device Single Audit Program (MDSAP) represents a significant collaboration in the field of international health regulation, designed to improve the efficiency and effectiveness of the audit process in the medical device industry. This initiative was developed by the International Medical Device Regulators Forum (IMDRF) and aims to simplify the regulatory compliance process for manufacturers globally.

MDSAP allows medical device manufacturers to undergo a single audit of their quality management systems and Good Manufacturing Practices compliance, conducted by an IMDRF-authorized and recognized auditing organization. The results of these audits are accepted by all participating program members (United States, Canada, Australia, Japan, and Brazil) as if the Good Manufacturing Practice certificates were issued by the Ministry of Health, thereby facilitating access to multiple international markets under a unified set of evaluation criteria.

Benefits of MDSAP Membership

Countries participating in MDSAP enjoy several key benefits:

Mutual Recognition of Audits: This allows for greater consistency and predictability in audit outcomes, reducing redundancy and regulatory burden for manufacturers.
Resource Optimization: Both regulatory authorities and manufacturers can better allocate their resources by avoiding multiple independent audits.
Standardization of Standards: The program promotes uniformity in safety and quality standards, raising the overall level of products available in the global market.

Commitments of Participating Regulatory Agencies

By adhering to MDSAP, regulatory agencies commit to:

Accept and respect the audit reports generated under MDSAP, ensuring effective collaboration and mutual trust among member countries.
Contribute to the ongoing development and improvement of the program, including regular updates to audit criteria to accommodate technological advances and new regulatory challenges.
Promote the adoption of global regulatory practices, thereby facilitating a safer and more effective environment for health products worldwide.

Mexico’s Membership in MDSAP

Mexico’s affiliation with MDSAP, confirmed on November 2, 2023, marks an important milestone in its trajectory as a global health regulator. Through COFEPRIS, Mexico has demonstrated its commitment to adopting international standards and strengthening international cooperation to ensure the safety and effectiveness of medical devices. This achievement not only enhances national public health protection but also significantly contributes to global well-being, positioning Mexico as a proactive leader in the harmonization of international health regulation, and favors trade and authorization of new products.

As an affiliated member of MDSAP, COFEPRIS is responsible for recognizing MDSAP audit results through the presentation of a valid MDSAP certificate as equivalent to the Good Manufacturing Practice Certificate issued by this regulatory entity for the purposes of sanitary registration in Mexico. That is, a company that manufactures products in Mexico for sale in this country can present the MDSAP certificate for registration purposes without requiring one issued by COFEPRIS, and this authority will accept it.

Sources:

International Medical Device Regulators Forum (IMDRF): Documents and publications related to MDSAP.
Federal Commission for the Protection against Sanitary Risks (Cofepris): Official communications on Mexico’s membership in MDSAP and its implications.
Specialized publications in health regulation and medical devices: Articles discussing the implementation and benefits of MDSAP.

Medical devices

Health 4.0: Do You Know the Concept?

Post author By DANIEL VILLENA
Post date 31 July, 2024

Revolutionising the Medical Device Industry

What is Health 4.0?

Health 4.0 is a concept that arises from the fourth industrial revolution, or Industry 4.0, which integrates advanced technologies such as Artificial Intelligence (AI), the Internet of Things* (IoT), Big Data, and robotics to transform healthcare services. This new era is characterized by the digitization and connectivity of healthcare systems, improving the efficiency, accuracy, and personalization of medical treatments. The adoption of these technologies aims not only to optimize medical processes but also to provide more preventive and predictive care.

This term has had a significant impact in the health field and has quickly permeated the Medical Devices industry, enabling:

Remote Monitoring: Connected devices can send real-time data to healthcare professionals, improving the management of chronic diseases.
Accurate Diagnostics: AI and Big Data assist in interpreting medical images and analyzing data, reducing errors and improving diagnostics.
Personalized Care: Personalized medicine becomes more accessible by analyzing large volumes of data to tailor treatments to each patient’s specific needs.
Operational Efficiency: The automation of processes and the use of robots in surgery and other medical procedures improve precision and reduce recovery times.

The development of Health 4.0 has been driven by advances in various technologies and the growing demand for more efficient and effective healthcare services. From the use of wearable devices that monitor health to the implementation of AI-based hospital management systems, the evolution has been rapid and promising. Countries such as the United States, Germany, and Japan have led this transformation, integrating these technologies into their healthcare systems with notable success.

Health 4.0 Goals

The main goals of Health 4.0 include:

Improving the quality of healthcare.
Reducing operational and treatment costs.
Promoting preventive medicine.
Facilitating access to healthcare services in remote areas.
Increasing patient satisfaction through personalized care.

What is the situation of Health 4.0 in Mexico?

In Mexico, the concept of Health 4.0 is beginning to gain ground. Although still in its early stages compared to other countries, important steps are being taken. Institutions such as the National Institute of Public Health (INSP) and private sector companies are investing in Health 4.0 technologies. Pilot projects in telemedicine, the implementation of Electronic Health Records, and the use of connected medical devices are demonstrating the potential benefits of these innovations.

Although our health regulatory entities have started to adapt regulatory frameworks to incorporate new technologies, there is still a need to adapt or generate new standards to have a regulatory framework that allows us to authorize safe, effective, and quality new technology products and stay at the forefront of digitalization.

Actions taken so far include specific guidelines that COFEPRIS has developed for evaluating emerging health technologies, including the assessment of safety, efficacy, and quality of devices based on new technologies such as Software as a Medical Device and the requirements for obtaining their Health Registration. This has been included in the recent NOM 241 and now in the pharmacopoeia supplement for medical devices.

The integration of new technologies also presents regulatory challenges; and to achieve significant progress, regulatory entities in Mexico and the regulated sector must work closely to ensure their products comply with current regulations and anticipate future regulatory changes, such as:

Mexican Official Norm NOM-241-SSA1-2012: Companies must ensure that connected devices and those based on Health 4.0 technologies comply with Good Manufacturing Practices requirements for medical devices.
Mexican Official Norm NOM-240-SSA1-2012: It is crucial to ensure that connected devices that collect and transmit real-time data comply with medical device Surveillance and adverse event reporting requirements.
Regulation of Health Supplies: This regulation should include procedures for the authorization and surveillance of these medical devices in Mexico. It is important to work on updates to include the specifications of Health 4.0 devices, especially those employing AI and Big Data; we hope the ongoing modification will include them.
General Health Law: With the proposal for the implementation of Electronic Registrations, it is essential to guarantee patient data protection. It is a great example of the beginning of digital health.

The medical device industry in Mexico is in a crucial position to leverage the benefits of Health 4.0, which represent a significant transformation in the global health sector and offer a unique opportunity to improve the quality of healthcare in Mexico.

The integration of advanced technologies not only promises to make treatments more efficient and personalized but can also reduce costs and improve access to healthcare. While Mexico still has regulatory and implementation challenges to overcome, the advances already made indicate a promising future for the adoption of Health 4.0. Collaboration between regulators, health institutions, and the medical device industry will be crucial to reach the full potential of this technological revolution in healthcare.

*IoT allows these smart devices to communicate with each other and with other internet-enabled devices. Just like smartphones and gateways, a wide network of interconnected devices is created that can exchange data and perform various tasks autonomously.

Medical devices

Do you know the characteristics of a Good Manufacturing Practices Certificate for the application for a Registration of foreign-manufactured Medical Devices in Mexico?

Post author By DANIEL VILLENA
Post date 31 July, 2024

The Good Manufacturing Practices (GMP) Certificate is the legal document that certifies that the company manufactures its products under conditions and practices based on a series of norms and/or standards that ensure the quality, efficacy, and safety of Medical Devices; and that they meet the necessary requirements in compliance with the applicable regulations to produce products with the three indispensable characteristics mentioned above.

Essential characteristics of the GMP Certificate

For a GMP Certificate to be valid in Mexico, it must meet the following characteristics:

Scope of the Certificate: The document must certify the manufacturing line(s) of the product(s) to be registered. It is crucial that the scope of the certificate is clearly defined and matches the products intended to be marketed in Mexico.
Validity of the Certificate: The certificate must be valid at the time of the Registration submission. If the document does not contain an explicit expiration date, the inspection date for issuing the certificate must not exceed 30 months.
Authentication of the Certificate: To guarantee the validity of the certificate, it must be authenticated according to the following procedures:

Legalization: For countries not part of the Hague Convention, the certificate must be legalized by the Mexican consul in the country of origin.
Apostille: For member countries of the Hague Convention, the certificate must be apostilled. The Apostille must be issued only by a competent authority designated by the State of origin of the document.

Note: In the case of ISO 13485 or MDSAP certificates, the Apostille can be issued in the manufacturer’s country or the country of the certifying body.

Language of the Certificate: It can be submitted in Spanish or English. If the document is in another language, a translation by an authorized expert translator in Mexico will be required.
Presentation of the Certificate: The certificate can be submitted in its original format or as a notarized copy in Mexico.

Equivalent Documents

ISO 13485 Certificate – Issued by an authorized body.
MDSAP Certificate – Issued by an authorized body to certify this type of audits.
CE Mark Certificate for medical devices – Issued by an authorized body in the European Union.
Declaration of compliance with Good Manufacturing Practices included in the Free Sale Certificate (FSC) – The FSC must be issued by the Ministry of Health of the issuing country or, where applicable, by the relevant Ministry that regulates the product.

Harmonization with international standards

The characteristics of the GMP Certificate for medical devices in Mexico are aligned with international standards established by organizations such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). This regulatory harmonization facilitates the international trade of medical devices and ensures public health protection globally.

Source:

Pharmacopoeia of the United Mexican States Supplement of Medical Devices 5.0, 2023

Medical devices

Concepts related to the classification of Medical Devices in Mexico

Post author By DANIEL VILLENA
Post date 24 July, 2024

Technical filtration equipment in hand macro

In Mexico, Medical Devices are classified according to the risk involved in their use, for registration purposes, so we have the following three classes:

Class I: Those supplies known in medical practice and whose safety and effectiveness are proven, and generally, they are not introduced into the body.

Class II: Those supplies known in medical practice and that may have variations in the material with which they are made or in their concentration, and generally they are introduced into the body for less than 30 days.

Class III: Those supplies that are new or recently accepted in medical practice, or that are introduced into the body and remain in it for more than 30 days.

These three classes are ruled by the contact time of the MD with the user or patient; however, we have a supplement for Medical Devices of the Pharmacopeia of the United Mexican States that contains 35 specific rules that help us classify an MD for application purposes of the Registration in Mexico.

These rules define criteria that must be considered to determine the class of the MD, and for their correct application, therefore it is necessary to know the following:

The application of these criteria for classification is ruled by the intended purpose of use of the MD.
If several rules apply to an MD, the rule that corresponds to the highest classification is applied.
If an MD is intended to be used in combination with another Medical Device, the classification criteria will apply for each of the products separately.
Software that is part of a Medical Device or influences its operation will be included in the same category.
If an MD is not intended to be used exclusively or mainly on a specific part of the body, the most critical specific use will be considered for classification.

It is important to keep the following concepts in mind when reviewing the rules:

Non-invasive Medical Device: It does not have contact with the patient or only has contact with the patient’s skin.
Invasive Medical Device: Partially or completely penetrates the interior of the body through a body orifice.
Surgical-type invasive medical device: Penetrates the interior of the body through the body surface with a surgical intervention. MDs whose penetration into the interior of the body does not occur through recognized body orifices are also considered.
Body orifice: Any natural opening in the body, the external surface of the eyeball, or a permanently created artificial opening (Example: a stoma).
Implantable Medical Device: Any device that is completely introduced into the body or that replaces an epithelial surface or surface of the eye (they can be partially or absorbed); by surgical introduction, that is intended to remain in the body after the procedure. Any MD that is partially introduced into the human body through a surgical intervention and that remains in the body for more than 30 days is also considered in this category.
Active Medical Device: One whose operation depends on a source of electrical energy or any source of power different from those generated directly from the human body or by gravity, and that works in conversion of that energy; In short, to function, they need to be connected to any power source.
Duration: Time of permanence or contact of the Medical Device with the human body.
Transitory use: Intended to normally be used continuously for less than 60 minutes.
Short-term use: Normally intended to be used for no more than 30 days.
Long-term use: Intended to be used continuously for a period longer than 30 days.

A little more about the classification rules…

Rules 1-4 describe non-invasive Medical Devices:
- Examples:

That is in contact with the skin: Gauze, urine collectors, bandages, dressings, probes for electrocardiograms.

That involves the storage, conduction, and perfusion of blood, body fluids, tissues, liquids, or gases: Blood collecting tubes, hemodialysis machines, bags containing saline solutions.

Rules 5-10 describe invasive Medical Devices.
- Examples: Invasive that involve body orifices in their use: Urinary catheters, gloves, dental implants, and bridges, prostheses.
Rules 11-17 apply to active medical devices, that is, those that are in contact with the human body in the short and long term.
- Examples: Active MD for diagnostic purposes: Ultrasound, oximeter, stethoscope, thermometers, blood pressure devices
- Intended to manage or exchange energy: Tomography, X-ray machines, incubators, and supplies for dental use.
- Software as a medical device: Mobile applications.
Rules 18-23 describe special criteria, for example: for medical devices that are intended to aid the incorporation of a drug product or nanomaterials into the body, MD used for contraceptive purposes or the prevention of sexually transmitted diseases, intended for disinfection or decontamination.
- Examples: Male and female condoms, non-medicated and medicated intrauterine devices, and subdermal implants used as contraceptive methods
Rules 24-33 apply to In Vitro Diagnostic Agents, these will be classified according to their indication for use and the level of risk that an erroneous result could cause serious disability or death of the patient, fetus, or embryo.
- Examples: Contrast media, Diagnostic tests (for HIV, HCV, HTLV, etc.), tests for the detection of markers, reagents, calibrators, and culture media.
Rule 34 describes Hygienic Products
- Examples: antiseptic gel, tampons, lubricants.
Rule 35 refers to low-risk Medical Devices
- Examples: Face masks, surgical masks, body control scales, sheets, and fields for surgical use

In conclusion, we can state that the correct classification of medical devices represents a great challenge, due to the variety of MDs that are on the market and the technological advances that are continually taking place, however, for the registration application it is essential to classify the product in question correctly, since according to this class the payment fees will apply, the requirements demanded by COFEPRIS and we will be able to obtain the registration avoiding the issuance of a deficiency letter due to errors in classification.

Fortunately, we have these 35 rules that represent an important tool, since they provide an orderly and systematized method for the correct classification of a medical device, taking into account the intended use of the product, the contact time with the body, if it is required energy for its use, if it emits any type of energy for therapeutic purposes (p.e. x-rays), if it is introduced into the body, the level of risk if an erroneous result is given if it is software; the fact that they are very specific makes correct application easier and they help us to identify the most suitable class according to the characteristics of the product in question.

Source:

Pharmacopeia of the United Mexican States Medical Device Supplement 5.0, 2023

Health Regulation

Cofepris actions in clinical research

Post author By DANIEL VILLENA
Post date 19 June, 2024

During the current administration, Cofepris has set the objective of promoting clinical research in Mexico.

This subject had not received the necessary attention in the past, and therefore, there is a significant delay in the evaluation and authorization of clinical study protocols that have led to the reduction of clinical research in Mexico as well as the delay of international protocols.

Among the actions that Cofepris has taken to achieve their objective are the following:

1. Launching of the DIGIPRIS platform for Research and Clinical Trials, in December 2023, where users electronically submit clinical studies for evaluation and authorization. The responses to these procedures are also provided electronically through this same portal. With this, Cofepris estimates to reduce the evaluation times by up to 75% and from December 2023 to May 2024, approximately 90 clinical trials have been authorized through this platform.

2. The publication of the draft for PROY-NOM-262-SSA1-2024 Good Clinical Practices. April 24th, 2024. Although it is still a draft, represents a significant progress as it officially implements Good Clinical Practices in Mexico and, above all, it specifies how they will be implemented in clinical research. Because previously they had only been published as guidelines to comply with Good Clinical Practices in research, but a guideline is not the same as a NOM (Mexican Official Norm), that is aligned to ICH and it details what they consist of and how to apply them, in addition to the Publication of the NOM in the DOF (Official Gazette of the Federation) would make its implementation and compliance mandatory for anyone carrying out clinical research in humans in Mexico.

3. In addition, on May 14th, Cofepris published additional measures to optimize and increase transparency in the evaluation process of clinical trials submitted through the DIGIPRIS platform; among which are:

– Recognition of criteria and evaluation results authorized by ethics, research and biosafety committees presented by the applicant.

– Standardization of evaluation criteria for clinical studies, approaching the best clinical research practices established by ICH.

– Optimization of processes in the import permits for health supplies that are required as part of a clinical research, in order to comply with the legal deadlines established for these procedures.

– Publication of the criteria to be assessed in the clinical studies.

With this set of actions, Cofepris demonstrates its determination to increase and attract investments in clinical research in Mexico.

Especially the use of the DIGIPRIS platform has been widely accepted by users and has managed to speed up the evaluation and authorisation of clinical studies, however it is still premature to quantify the impact of this set of actions on the protocols conducted in Mexico. Without a doubt, clinical research is a great area of opportunity for the growth of the country and to progress in access to new therapeutic options and advanced therapies.

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