Application for Sanitary Registration: Where to start?
In order to know the regulatory route and documents that you must submit for the purpose of marketing a medical device (MD), you must ensure that the product is really a MD and, subsequently, make the correct classification based on its health risk.
According to the definition of MD described in NOM-241-SSA1-2021, in general terms, it mentions that it can be an implant, material, substance or similar product, utensil, diagnostic agent, software, instrument, apparatus or machine, whose purpose of use is related to the diagnosis, prevention, surveillance, monitoring or is auxiliary in the treatment of a disease or injury.
If the indication for use of the product is related to what is described in the definition of medical device, then it can be considered as such.
Subsequently, a classification must be made based on its risk, which is described in article 83 of the Health Inputs Regulation, which classifies them as follows:
CLASS I. Known in medical practice, proven safety and efficacy and generally not introduced into the body.
CLASS II. Known in medical practice, they may have variations in the material with which they are manufactured or in their concentration and, generally, they are introduced into the organism and remain in the body for less than thirty days.
CLASS III. New or recently accepted in medical practice, or that are introduced into the organism and remain in it for more than thirty days.
Additionally, there is an additional classification in the Supplement for Medical Devices 5.0 of the Pharmacopoeia of the United Mexican States (FEUM):
Class I-low risk: those whose safety and efficacy is duly proven and supported by various means of technical and scientific information, and whose purpose of use does not require them to be supplied sterile, have no measuring or life support function, and whose use does not represent unacceptable health risks.
Finally, in order to perform the correct classification, the same FEUM Supplement describes 35 rules based on the following considerations:
- Degree of invasiveness
- Duration in the organism
- Energy use
- Diagnostic agents
- Hygienic products
- Special rules
These rules are an excellent tool that will help you to accurately classify your device and, with it, submit the accurate documentation and correct payment within your application for sanitary registration for marketing purposes.
Registration of medical devices before COFEPRIS
In Mexico, the Medical Devices industry represents one of the sectors that has shown sustained growth in recent years. In 2018, it was declared by the Mexican Government, along with the pharmaceutical industry, as a strategic and priority sector for Mexico's economy and health.
Medical Devices: Sanitary Registration
In order to apply for a sanitary registration, a dossier must be submitted with administrative-legal and technical information that complies with the requirements requested by the authority (COFEPRIS), as well as with specific characteristics for the correct entry in its Integral Service Center (CIS).
Once the sanitary registration is obtained, it will be valid for 5 years and may be extended for an equal period. Additionally, during this period, changes to the authorized conditions may be requested as required by the holder.
Regulatory Entity in Mexico: COFEPRIS
The Federal Commission for Protection Against Health Risks (COFERPIS) is a decentralized administrative body of the Ministry of Health, with technical, administrative and operational autonomy, which is responsible for the exercise of powers in the areas of health regulation, control, surveillance and promotion. Among the products and services it regulates are Medical Devices, Medicines, Cosmetics, Food Supplements, among others.
Regulation of Medical Devices in Mexico: Considerations for Commercialization
Learn about the key aspects for the regulation and commercialization of medical devices in Mexico, including registration requirements before COFEPRIS, labeling, conformity assessment and essential procedures to comply with current regulations.
Interested Parties: Registry Holder
(Mexican Registry Holder), manufacturers,
importers and distributors, importers and distributors.
Holder (Mexican Registration Holder): According to the regulations, the holder of the sanitary registration is defined as the individual or legal entity that holds the authorization granted by the Ministry of Health (COFEPRIS) for the manufacturing, distribution, and/or commercialization of a medical device and must have a registered establishment in Mexico. There are companies that offer their services as the holder (or holder) and legally represent foreign manufacturers who do not have an establishment in our country.
Manufacturer: The entity responsible for the safety, quality, design, manufacturing, conditioning, assembly of a system, restoration, modification, adaptation, or remanufacturing of a medical device before its market release.
Legal Manufacturer: The entity responsible for the safety, performance, quality, design, manufacturing, conditioning, assembly of a system, or restoration, modification, or adaptation of a medical device before its commercialization.
Actual Manufacturer: The entity in charge of the manufacturing, assembly, or remanufacturing of a medical device (which may be a subsidiary of the legal manufacturer) or contracted by the legal manufacturer to produce the device through a maquila contract.
Importer and Distributor: Entities responsible for importing the medical devices into the country and distributing them under controlled conditions to ensure the product’s quality.
Application for Sanitary Registration: Where to start?
Organization and structuring of essential documents to comply with regulatory and administrative requirements.
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- Review the information requested by the authority according to the class of medical device to be registered. You can consult it in the following links: Registros Sanitarios | Formatos Vigentes (COLOCAR LINKS)
- If the medical device is of foreign manufacture, consider the characteristics that the legal documents that will integrate the dossier must comply with: legalizations, apostilles, consularizations, translations by an expert, translator, etc.
- The information may be in Spanish or English. Any information in a different language must be translated into Spanish.
- The file must be presented in a continuous folio, in descending order (from back to front).
In case of any omission of information or documents, the authority will issue a request to submit the missing information (prevention), resulting in a long response time until the final resolution is obtained. Therefore, it is very important that from the initial request the dossier is as complete as possible to avoid delays in the issuance of the requested registration or procedure