Regulatory process for marketing medical devices in Mexico

Mexico is an attractive market to many medical device manufacturers. In 2008, medical devices imported into the country were valued at US $3.1 billion. Also, from 2006-2008 there was an annual increase (in dollars of imported medical devices) of approximately 11%, indicating an increasing demand for imported medical devices. Mexico also has a large population; according to recent estimates, the country’s population ranks 12th in the world.

For some time now there have been delays in the reviews of medical device submissions in Mexico. This is due to the high volume of submissions as well as to a shortage in the number of staff reviewing medical device submissions. Also, a regulatory amendment that was published on January 2, 2008 requires that all existing medical device registrations older than five years must be renewed by 24 February 2010. This was to better align the registrations since, all new registrations since 2007 were included with the text that the registrations were only valid for a period of five years.

A new amendment that was published on 19 June might speed up the regulatory process. The amendment sets out strict rules on deadlines for reviewing regulatory submissions for imported devices. It will, at the very least, make clear the status of a medical device submission.

This article focuses on the registration process for medical devices in Mexico with a particular emphasis on imports.

COFEPRIS

In Mexico, medical devices fall under the purview of the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of the Ministry of Health (Salud or Secretaría de Salud).

COFEPRIS’s mandate covers applying national health risk protection policy; improving and exercising the regulation, control, sanitary surveillance and evaluation of health risks from products, activities and establishments under its competence; and carrying out the Health Ministry’s functions on the environmental impact on health, occupational health, hazardous residues, basic sanitation, accidents involving toxic, dangerous or radioactive substances and health protection in advertising. COFEPRIS, which was established in July 2001, comprises the following five integrated directorates: Medicinal Products and Health Technologies, Sanitary Control of Products and Services, Environmental and Occupational Health, Sanitary Control of Advertising, and the National Public Health Laboratory.

Mexican laws and regulations

The legal framework for the medical device regulatory process in Mexico is the General Health Law (Ley General de Salud).The law grants the relevant ministries and agencies in Mexico the authority to establish regulations within their mandate to protect humans, animals, plant health and the environment. It also establishes the administrative procedures by which regulations are developed and promulgated.

Article 194 bis of the law defines health supplies that are the subject of the law. Articles 204 and 376 stipulate that certain health instruments or health supplies sold or supplied in Mexico require health authorisation and registration (registro sanitario). Article 262 describes the following six categories of medical device use: medical equipment; prosthesis, orthosis and functional aids; diagnostic agents (in vitro diagnostic devices); odontological supplies; surgical materials and wound care; and sanitary products.

An implementing regulation that provides greater context to the law is the Regulation of Health Supplies (Reglamento de Insumos para la Salud). The regulation grants COFEPRIS the power to act independently of the Mexican Ministry of Health. The regulation – specifically under the Second Title, Supplies, and within Chapter 9, Other Supplies, Article 82 – specifies that the six categories of products above (and other devices for medical use) require a sanitary registration if they are to be produced, sold or distributed in Mexico.

Definition and classification

There is no formal definition of a medical device in the Ley General de Salud or in the Reglamento de Insumos para la Salud. A description of the products in the six categories of use is provided in Article 262 of the Ley General de Salud. The definition of a medical device is included in a general COFEPRIS guidance document on the requirements to register medical devices as well as in a COFEPRIS Frequently Asked Questions document on medical devices. The definition is as follows:

Substance, mixture of substances, material, apparatus or instrument (including the software for its appropriate use or application), used alone or in combination in the diagnosis, monitoring or prevention of illnesses in humans or in the processing of the same and of the disability, as well as employed in the replacement, correction, restoration or modification of the anatomy or human physiological processes.

Medical devices are divided into one of three classes according to their level of risk. Article 83 of the Reglamento de Insumos para la Salud delineates the three classes as follows:

  • Class I devices are known in medical practice, have a proven safety and effectiveness and are generally not introduced into the human body;
  • Class II devices are known in medical practice, there might be variations in the materials the devices are made from or in its concentrations, and are generally introduced into the human body for less than 30 days; and
  • Class III devices are new or recently accepted in medical practice or are introduced into the human body permanently or for longer than 30 days.

The descriptions of the three classes are ambiguous as the terms “known in medical practice” as well as “new” and “recently accepted” are contentious. Download our free process chart for a more detailed on the COFEPRIS regulatory process for each type of device.

The ministry’s health products technical committee (Comité Técnico de Insumos para la Salud) has posted classification guidelines for medical devices based on the level of risk. The guidelines consist of 20 rules. Rules 1 through to 18 are similar to the European medical device classification criteria described in Annex IX of the Medical Devices Directive 93/42/EEC. For example, the classification guidelines and Annex IX both contain the following: rules 1-4 describe noninvasive devices, rules 5-8 describe invasive devices, rules 9-12 describe active devices and rules 13-18 are special rules. Rules 19 and 20 of the guidelines assign the classification for IVDs.

The COFEPRIS website provides additional documents to facilitate product classification. It provides a catalogue of 941 medical devices classified according to risk classification and category of use13, a list of medical devices that would be classified as Class I14 and a list of products that are not considered medical devices. As an example of an entry from the catalogue, an expandable cervical dilator is classified as Class II and assigned to the medical equipment category of use.

Manufacturers that still have questions on classification should submit their inquiries simultaneously to COFEPRIS and to their customs broker (agente aduanal).

The customs broker refers to its customs books to assign a code or classification and determines whether a permit or registration is required for importation. Medical device registrations must be renewed every five years as ascribed by registrations obtained in 2007. Further, after all the older registrations have been renewed by 24 February 2010 (Amendment January 2, 2008), these registrations will be valid for only five years.

Medical device registration steps

The requirements for medical device registration submissions to COFEPRIS are described in Articles 179 and 180 of the Reglamento de Insumos para la Salud. The list below outlines the documentary information that must be included in a registration submission (Formato de Solicitudes):

  • scientific and technical information that substantiate that the device complies with safety and effectiveness characteristics;
  • the label in Spanish according to corresponding official Mexican norms or standards; • the instructions for use in Spanish;
  • the general description of the manufacturing process for the medical device;
  • a description of the structure, materials, parts, and functions of the medical device;
  • the laboratory tests to verify the specifications of the medical device;
  • bibliographical references; and
  • references to corresponding official Mexican norms, if relevant.

Further, if the manufacture of the device does not take place in Mexico, Article 180 stipulates that the following additional information is required:

  • a certificate of free sale or equivalent issued by the health authority of the country of origin;
  • an authorisation letter from the manufacturer, certified according to the legal procedures in the manufacturer’s country of origin. This should be written in Spanish but, if it is in another language, it should be accompanied by a Spanish translation officially legalised by the official procedure in the manufacturer’s country of origin, if the medical device is not manufactured by the main factory or laboratory that is requesting registration;
  • a good manufacturing practices certificate issued by the health authority of the country of origin or equivalent medical device quality system certification (ISO 13485:2003 certificate); and
  • a copy of the certificate of analysis issued by the manufacturing company using the manufacturer’s letterhead and signed by the responsible quality control representative.

For manufacturers not established in Mexico, the form for making a regulatory submission (Formato de Solicitudes) is COFEPRIS-04-001-B. There is a general form that has to be completed and there are guides and instructions to facilitate its completion. There is also a detailed description of the information (Annexes) that must be submitted with the medical device submission.

Standards

The Secretariat of Commerce and Industrial Promotion (Secretaría de Comercio y Fomento Industrial, SECOFI) is responsible for the standards system in Mexico. The system includes mandatory and voluntary standards. Official standards (Norma Oficial Mexicana; NOM) are published in the country’s official journal (Diario Oficial de la Federación). Salud issues the NOMs relevant to medical devices (format: NOM-XXX-SSA1-YYYY). Forty seven official Mexican standards are currently posted on the COFEPRIS website. That said, 37 medical device NOMs ‒ 36 of which are currently listed on the COFEPRIS Web site ‒ were recently cancelled. The voluntary standards are known as NMXs. In Mexico, anyone can propose that a standard be created, revised, amended or cancelled.

Device labelling

One NOM that has not been cancelled specifies labelling requirements for medical devices. NOM-137-SSA1-2008 became effective on 12 February 2009, making NOM-137-SSA1-1995 obsolete (although the COFEPRIS website still references the 1995 version). NOM-137-SSA1-2008 is partially compliant with the European Norm EN 980:2008 − entitled Graphical Symbols for use in the Labeling of Medical Devices − and it introduces symbols in normative appendices A and B. Appendices A and B describe 17 and 9 symbols respectively.

The 2008 version, in common with the 1995 version of the NOM, specifies the information that is expected to appear in medical device labels. The minimum labelling requirements can be found in section 4.1.1 through to 4.1.2 of the NOM. The information specified on the label must be in Spanish and must be legible and understandable. The generic and specific names of the device, country of origin, sanitary registration number, expiration date, serial or lot number and contents must be on the label. The 2008 NOM also specifies that, if a medical device is manufactured by a third party for the sanitary registration holder, the name of the third party must be included on the label.

In-country representation

Medical device registration documentation must be submitted by an entity established in Mexico and registered with COFEPRIS. Typically, manufacturers use their distributors in Mexico as their Mexican registration holder. Mexican registration holders must also possess warehouse facilities that are inspected by COFEPRIS. A Mexican registration holder owns the medical device registration.

Distributors

Once the medical device registration has been reviewed and approved by COFEPRIS, the Mexican registration holder or the manufacturer issues letters appointing other distributors to the registration. The process of transferring a medical device registration in Mexico is simple and discussed in Article 190 of Reglamento de Insumos para la Salud. There is an accompanying guidance on the topic. Once approved, the procedure grants permission for other distributors to approach COFEPRIS for an import licence for those specific medical devices.

General considerations

The medical device submission includes a document that lists all the products to be registered with COFEPRIS and the corresponding catalogue numbers. While this serves as a guide for customs officials when they are reviewing importations, it is also a requirement that medical device manufacturers in Mexico to delineate all the salient catalog numbers associated with a registration. It is therefore imperative that all the products the manufacturer would like to sell in Mexico are included and delineated correctly in the listing provided. All additions or changes to the names or catalogue numbers require notification to COFEPRIS.

The customs officials also check the manufacturer’s address; changes of address must be submitted to COFEPRIS. It is crucial in Mexico that foreign manufacturers possess authorisation to market the medical device in their country of origin. While there is no definition of manufacturer in any of the legal texts, manufacturer is described in NOM-137-SSA1-2008 as the owner of the medical device who is legally responsible for the manufacture of the device in Mexico or abroad. The information about the manufacturer should be explicit and should not be confused with a third party or assembler.

Approval timelines

Articles 179 and 180 of Reglamento de Insumos para la Salud stipulate deadlines for COFEPRIS’s review of the Formato de Solicitudes for imported devices (COFEPRIS-04-001-B). Under the requirements, Class I devices are to be reviewed within 30 days, Class II devices within 35 days and Class III devices within 60 days. Recent changes – for additional details, see below under “Amendments” – mean Class II and III devices will be considered rejected if COFEPRIS does NOT respond to the company at all within the specified timeframes.

Vigilance

Vigilance is mentioned in Reglamento de Insumos para la Salud in Articles 38 and 39. Adverse events that occur during the commercialisation of a medical device must be notified to Salud; these include adverse events that have occurred worldwide.

Amendments

From time to time, amendments to the regulatory documents are published. The amendment requiring that all existing medical device registrations be renewed every five years and by 24 February 2010 is an example. (Beginning in 2007, all registrations were approved with a five year limit.) One of the most recent amendments was published on 19 June 2009.

This amendment was published partially in response to the country’s National Development Plan 2007-2012 (Plan Nacional de Desarrollo 2007-2012), which has as an objective the improvement of the living conditions of Mexicans by making the economy more competitive, generating jobs and facilitating business development.

As part of this mandate, it was necessary for Salud to update the different formats, guides, instructions and required information that in future are to be submitted as annexes. Annex I of the amendment establishes those activities that require notice of operation (Aviso de Funcionamiento) or sanitary licence. Annexes II and III, while only initially referenced in the articles of the amendment, provide the formats, guidance documents and procedures for submitting a Formato de Solicitudes.

As stated above under “Approval timelines”, the amendment covers deadlines relating to COFEPRIS’s review of submissions for the registration of imported medical devices. The changes in the review times and in the acceptance or rejection of a submission are presented in tabular format, with a column for affirmative or negative. The new requirements are as follows:

  • for a Class I device, if there is no response from COFEPRIS within 30 working days, the submission is considered approved (aplica affirmative ficta solo para dispositivos médicos Clase I);
  • for a Class II device, if there is no response from COFEPRIS within 35 working days, the submission is considered rejected (aplica negative ficta para dispositivos médicos Clase II); and
  • for a Class III device, if there is no response from COFEPRIS within 60 working days, the submission is considered rejected (aplica negative ficta para dispositivos médicos Clase III).
     

Other amendments that affect the review time and the acceptance or rejection of administrative and technical modifications are as follows:

  • a request to modify the registration in a type “A” modality administrative modifications. These include: transfer of rights for the registration; change in address of the domestic or foreign distributor; change in name of the manufacturer or the distributor; or change of authorised distributor in Mexico; and
  • a request to modify the registration in a type “B” modality technical modifications. These include: radiation sources; change in third-party manufacturer (foreign or domestic); products packaged and labelled exclusively for public health institutions or social security; change of place of the manufacturer (foreign or domestic) including affiliated companies; new origin of the products being manufactured by affiliates or subsidiaries; change in the primary packaging and change in the class of the device; change in a formula that will not affect the active ingredient; or change in commercial name and/or catalog number of the product.

In both of the above circumstances, if there is no response from COFEPRIS within 22 working days, the request is considered approved.


This article was written by Evangeline Loh, VP of Regulatory Affairs for Emergo Group Inc. A complete list of references for this article is available upon request.