Ultimate Guide for Regulatory Affairs in Mexico.
In Veraque we are interested in providing you with the latest news and detailed information about regulatory and quality affairs in Mexico. This is a great resource, in case you are looking for an indepth description of the full regulatory process in Mexico. For a general overview you can check our website for each of the services we provide or contact us directly. We would be glad to send the information you are looking for. Also, if you are still not sure if your product is a medical device, we invite you to check our ultimate guide for classification and grouping. This is a great reference for the first step you want to take in the Mexican market.
To facilitate your information search, this guide details each of the following topics:
You can check any chapter independently if you are looking for a specific topic.
Finally, to keep things as easy as possible, we place every translation to Spanish in the footnotes.
We encourage you to use these translated terms if you are looking for a specific term in the
internet. Please note that the Spanish-English translations we use in this document are not official
terms.
The legal framework surrounding a medical device in Mexico.
Once you have identified if your products are medical devices, you may want to start preparing all the paperwork to receive a sanitary registration. However, you now need to know which documents are necessary and who requires you to present them. As in any other country, these requirements are generally based on a legal framework. In this guide we want to provide a quick introduction about the main legal references that will help you to bolster your dossier (the set of documents you will need to submit to the local authority).
- The general law of health1.
- Defines a medical device as a health supply in general terms.
- Divides medical devices in 6 groups.
- Medical equipment.
- Prosthesis.
- In-Vitro Diagnostic devices.
- Odontology related devices.
- Surgical materials and wound care related devices.
- Hygiene related devices.
- Classifies advertising into two branches:
- For healthcare experts.
- For the population.
- States that a medical device sanitary registration lasts 5 years.
- The general law for public administration procedures2.
- This document describes the obligations and rights when you submit a document to any public office in Mexico (including the ministry of health) and the rules to process and respond to such an inquiry.
- Health Supplies regulation3
- States that there are 3 different classifications for medical devices. Important Note: This, however, is not true since there are 4 medical device classes in Mexico. You can check our ultimate guide for classification and grouping for more references.
- Details the Sanitary Responsible role. This is a key person you must identify and appoint in any regulatory process. More references can be found in the stakeholders section of this document.
- Defines the timelines for responses. 30 to 35 work days upon submission. This is not the case for most of the submissions you will make. For a better estimate, please check the timeline section of this guide.
- Makes a general reference to the required documents you will need to present. Do not use this as your final checklist. There is a more detailed set of documents referenced in other legal documents.
- States that you must submit a renewal 150 natural days before the sanitary registration expiration date.
- Details the different types of import permits.
- States that advertising intended for health experts only requires a notice (not a permit).
- NOM-137. Medical device labelling requirements.
- It also states you can add a second label for the missing requirements based on this norm.
- Although not mentioned in this document, you are not obliged to comply with this norm upon entrance in customs. Nevertheless, the label with the missing information must be included before delivering it to the final client.
- NOM-240. Technovigilance program.
- Details the processes to correctly run a surveillance program in Mexico.
- NOM-241. Medical device good manufacturing practices.
- Details every requirement to be certified in Mexico for good manufacturing practices. It is also applicable for warehouses.
- It is not required if you are exporting to Mexico. This is only applicable for companies settled in Mexico and manufacturing a medical device. Please keep in mind, you always need to check first if your product is a medical device or not.
- FDA (US Food and Drug Administration), HC (Health Canada) and MHLW (Japan Ministry of Health, Labour and Welfare) Equivalency Agreement.5
- This agreement details the requirements for the so called FDA&HC&MHLW equivalency agreements. More details about the routes to register a medical device in Mexico can be found in this document.
- Agreement that classifies and codifies the health supplies that are subject to control by the ministry of health6.
- Identifies the tariff code for every health supply that concerns the ministry of health. This is a useful document to determine if the tariff code you will use to export a product will require any sort of permit. Share it with your customs broker.
- Keep in mind that this document is constantly being updated through amendments.
- Agreement in which the Ministry of Economy disseminates rules and criteria for Trade Commerce matters7.
- This agreement specifies if you need to pay a special fee based on the tariff code or if you need to comply with any other Mexican Official Norm. Share it with your customs broker for a better reference and to avoid extra requirements or complications.
- Agreement that lists the services and formats applicable to the ministry of Health8.
- Use this, in case you want to check all the services you can utilize through the ministry of health. Useful if you are a regulatory affairs consultant.
- Agreement that lists all the low risk medical devices and those products that are not considered medical devices9.
- This is your best reference in case you want to know if your product is not considered a medical device or a low risk class medical device. Unfortunately, this is not based on tariff codes.
- Supplement for health supplies establishments10.
- The Pharmacovigilance National Center11 is in charge of the preparation and any updates to this document. This is the gold standard reference for every medical device warehouse to understand what it is required to properly operate a warehouse in Mexico.
- Supplement for Medical Devices12.
- Again, the Pharmacovigilance National Center is in charge of this supplement. This document lists several (but not all) medical devices with the list of tests that you must do to get a sanitary registration. It also describes the analytical methods. The ministry of health reviewers uses this document as a reference to validate the tests you present.
- This document also has the classifications and grouping rules.
Inside COFEPRIS
The first step is to program a meeting to get your documents submitted. This must be done in person for many processes, but not for all of them. For instance, import permits can be submitted electronically. This is not the case for a new registration submission.
Once you have formally submitted, the Sanitary Authorization Commission14 is in charge to review and approve your request. Then, every letter you submit must be addressed to the Sanitary Authorization Commissioner in turn.
It is also of interest that the Sanitary Operation Commission15 is in charge of auditing your warehouse or any facility if located in Mexico.
The stakeholders in a regulatory project in Mexico.
Manufacturer located outside of Mexico
Legal responsibilities
The legal and/or real manufacturer does not have any legal binding with the ministry of health in Mexico.
Common role in a regulatory project
They supply the necessary paperwork for the ministry of health. Please keep in mind that only Mexican legal entities can submit documents to the ministry of health. Therefore, the manufacturer requires a representative (a holder).
Manufacturer located in Mexico
Legal responsibilities
The manufacturer must be compliant with the local good manufacturing practices (based on NOM-241).
Common role in a regulatory project
They can play the role of a Holder since they are located in Mexico. However, usually the manufacturer is a third party and the legal manufacturer is located outside of Mexico, then the third party manufacturer only provides the good manufacturing practices certificate to the Mexican Ministry of Health.
Holder in Mexico
Legal responsibilities
The ministry of health considers the holder as the
responsible party for any affairs related to the medical devices the holder owns. The holder is also responsible for complying with local warehouse regulations. In addition, the manufacturer must have a Sanitary Responsible who oversees all the operations in the local warehouse. Finally, the holder is also responsible to
maintain the technovigilance program (based on NOM-240). More details are covered in our registration holder ultimate guide.
Common role in a regulatory project
The holder submits the paperwork and maintains a communication channel with the manufacturer to inform him about any adverse incident.
Independent Regulatory Affairs Consulting Firm
Legal responsibilities
If they are not the holders, they do not have any legal responsibility.
Common role in a regulatory project
They can play a role as your holder or help you in some processes during the regulatory project such as peer-review.
Local Distributors
Legal responsibilities
If they are not the holders and are mentioned in the sanitary registration as importers and distributors, the local distributor responsibilities are the same as the holder, except they are not the main point of contact to the ministry of health. In other words, the local distributor is subject to receiving audits to its warehouse and is required to have a Sanitary Responsible and report any adverse incident.
Common role in a regulatory project
They can play a role as your holder and/or commercial activities. Please check our registration holder ultimate guide for more information about this.
Third Party Reviewers
These are COFEPRIS approved entities that deliver a pre-approval. COFEPRIS considers this pre-approval as a proof that another expert has evaluated the dossier resulting in an expedited review and response. This was an option a few years ago to provide time certainty. Nevertheless, this is no longer the case and we do not recommend to use this alternative.
The routes to register a medical device in Mexico
At this point, we have identified the rules and specific documents that lay behind every medical device sold in Mexico. In addition, we have identified the main stakeholders in a regulatory project, detailing the COFEPRIS departments related to your paperwork assessment. Now, it is time to talk in detail about the routes you can choose. It is worth mentioning that you may want to check our ultimate guides for classification and grouping and Mexican registration holder to know more about the first steps to take and the role of your holder in Mexico.
As in any country, we have to start with the medical device classification and grouping to identify the best regulatory pathway. Then, once you have achieved the classification and grouping assessment, you will end up with the following options:
- Class I low risk
- Class I
- Class II
- Class III
- Not a medical device
- Prepare and submit an open inquiry16.
- This is a letter justifying your reasons being to confirm that the product is not a medical device.
- The process is free but does not have a clear timeline for response. Sometimes, the authority does not even respond.
- Submit a dossier as a class I low risk device.
- The required documents to submit for a class I low risk are minimal (more details in the section requirements for the route you choose).
- The authority response is within a 3-6 months period and you will have a formal response either if COFEPRIS considers the device as a non-medical device or as a class I low risk, or even a higher class (class I, II or III). In other words:
- If it is not a medical device, COFEPRIS will detail the reasons.
- If it is a class I low risk, COFEPRIS will deliver a sanitary registration.
- If it is a class I, II, III, COFEPRIS will inform it and require the missing documents (check the following sections for more details).
We discussed in the section “the legal framework surrounding a medical device in Mexico” that there is an agreement that lists the non-medical devices and class I low risk devices. In the last section, we talked about a non-medical device, but what about if it is included in this list as a class I low risk device. Well, we might say you are fortunate since the paperwork you have to consider is minimal. Specifically, commercial brochures, instructions for use and labels, but no technical studies. In addition, it is necessary to consider a few legal documents: a power of attorney and distribution letters.
Finally yet importantly, you need a Holder. As mentioned in the “stakeholder in a regulatory project in Mexico”, the Holder in Mexico plays a key role for a successful experience in the country. We invite you to visit our ultimate guide about the holder role as your partner in Mexico.
A note to conclude this section is that this is the only class of medical device that is not subject to any other route or alternative, as we will see in the options you have for class I, II and III. Don´t worry! The good news is that this is not only a process requiring few documents, but also one that receives fast responses (3-6 months).
In case you consider your product is a class I, II or III medical device in Mexico, you have three regulatory pathways. First, you want to make sure that the product has been correctly classified. In our experience, some manufacturers take for granted that if their product is a class I in their country (e.g. USA) then it should be the same classification in Mexico. This is not necessarily true and we strongly recommend doing a classification and grouping based on the Mexican laws. We invite you to visit our ultimate guide for classification and grouping for further references.
Then, when you feel comfortable with the medical device classification, you must choose one of the three regulatory pathways the Ministry of Health offers. These are:
1. Standard.
- As its name indicates, this is the traditional route you can use. Compared with the equivalency route, the number of documents you have to present is more and it takes more time (more details in the timeframes section in this guide), both for compilation and for timeframe response.
2. Equivalency agreement route.
- This is applicable for all medical devices approved in USA.
- Or if it has been approved in Canada or Japan but is not class I in those countries.
- If it is class I, then you have to choose the standard or standard + third party routes
- Compared with the standard process, the number of documents you have to present is less as well as the timeframe to receive a response from the authority.
- Or if it has been approved in Canada or Japan but is not class I in those countries.
3. Standard + Third Party Route.
- This is only applicable for new registration or any other amendment and renewal as long as the registration was not granted under the Equivalency agreement. In other words, you cannot use this option if you have previously started your process through the Equivalency agreement route.
- But what is a Third Party Reviewer? These are COFEPRIS approved entities that deliver a pre-approval. COFEPRIS considers this pre-approval as a proof that another expert has evaluated the dossier resulting in an expedited review and response. An option if you want to have timeframe certainty or agile feedback.
- It is worth mentioning that the requirements are the same as in the standard process. In conclusion, the advantage is that you will save time with this option.
This may sound complicated, but you only have to check first which options are available for you. Then, balance time and requirements between options. What we consider important to point out is that the third party option is never eligible if you have decided to work before with the equivalency route.
At this point, you now know the classification of the product and the pathway you want to follow.
We want to end this section by describing the processes you can do or have to do with your sanitary registration in Mexico:
- New Registration.
- Modification.
- Technical.
- In case, you want to add a product or change a manufacturer. There are more options for which you can contact us for more details.
- Administrative.
- The most common are rights transfer or add/take off local distributors.
- Technical.
- Renewals.
- Your sanitary registration lasts 5 years.
- 150 days before expiration, you have to submit the renewal application. In addition, you have to submit the technovigilance information 3 months prior those 150 days. Therefore, we generally recommend starting this process one year before expiration.
- Import Permits.
- This is applicable for some products even if they have a sanitary registration. Some implants or high-risk products are considered in this group.
- As with class I low risk devices, you only have one option for submission.
Timelines
We have talked a lot about the timelines. In an effort to make this easy for you, this is a summary for different pathways and processes. Please consider that none of them is based on legal information but rather on our experience throughout the years. In addition, this time is based upon submission of your documents to COFEPRIS.
- Class I low risk: 3 months.
- Class I, II, III Standard Pathway: 16+ months.
- Class I, II, III Equivalency Agreement Pathway (if approved in USA or Canada): 8 months.
- Class I, II, III Equivalency Agreement Pathway (if approved in Japan): 8 months.
- Class I, II, III Standard + Third Party Reviewer: 16+ months.
- Administrative Modification (any pathway): 6 months.
- Technical Modification Standard: 16+ months.
- Technical Modification with Third Party Reviewer: 16+ months.
- Renewals (Standard or Equivalency Agreement): 12+ months.
- Renewals with Third Party Reviewer: 12+ months.
- Import Permits: 3-4 weeks.
What is a prevention
- The ministry of health informs through their webpage that you have an answer (however, you may not know if it is a prevention or not).
- The holder must go for such response to the ministry of health facilities. Once the response is picked up the time starts running.
Useful references
We offer some useful references you can check in the internet. You can use an automatic translator to have a better understanding of these documents. If this is not sufficiently clear or difficult to access for information feel free to contact us with any questions, and we will be glad to help you.
For any legal framework review. If you have the name in Spanish of the legal document you are looking for, type it in an internet search engine and check if it directs you to the Official Mexican Diary webpage, this is the most trust-worthy reference you may have.
The legal Pharmacopeia offers general reference for any supplement you may be interested in. Keep in mind that accessing these documents has a cost.
References
1 Ley General de Salud.
2 Ley Federal de Procedimiento Administrativo.
3 Reglamento de Insumos para la Salud.
4 Normas Oficiales Mexicanas (NOM)
5 Acuerdo por el que se reconocen como equivalentes a los requisitos establecidos en los artículos 179 y 180 del reglamento de insumos para la salud […]. The MHLW and FDA/HC are separate agreements.
6 Acuerdo que establece la clasificación y codificación de mercancías y productos cuya importación, exportación, internación o salida está sujeta a regulación sanitaria por parte de la Secretaría de Salud.
7 Acuerdo por el que la Secretaría de Economía emite reglas y criterios de carácter general en materia de Comercio Exterior.
8 Acuerdo por el que se dan a conocer los trámites y servicios, así como los formatos que aplica la Secretaría de Salud, a través de la COFEPRIS.
9 Acuerdo por el que da a conocer el listado de insumos para la salud considerados como de bajo riesgo para efectos de obtención del Registro Sanitario, y de aquellos productos que por su naturaleza, características propias y uso no se consideran como insumos para la salud y por ende no requieren Registro Sanitario.
10 Suplemento para establecimientos dedicados a la venta y suministro de medicamentos y demás insumos para la salud.
11 Centro Nacional de Farmacovigilancia.
12 Suplemento para Dispositivos Médicos.
13 Comisión Federal para la Protección contra Riesgos Sanitarios.
14 Comisión de Autorización Sanitaria.
15 Comisión de Operación Sanitaria.
16 Escrito libre.
17 Prevención.