Modifications to Medical Device Registration in Mexico

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, revised the Guidance Document by defining types and impact of product or organizational modifications on premarket registrations.

Before that COFEPRIS released a statement announcing that new classification criteria for modifications of sanitary registrations for Medical Devices. The new classification criteria will be applicable starting August 28, 2023, replacing the previous criteria implemented in February 2022. Following that COFEPRIS published on August 9’th that provides some significant details related to identifying the criteria and obligations for the modification of sanitary registrations, submission process, specifying the description of the obligations for the procedures for modifications to the health registry of Medical Devices. It has also mentioned that Modifications will now need to be submitted electronically.

Revised COFEPRIS rules for modifications to sanitary registrations

The initial part of the Guidance guidance document explains the concepts of Legal Manufacturer and Real Manufacturer.

• Legal Manufacturer: Natural or legal person responsible for the safety, performance, quality, design, manufacture, conditioning or assembly of a system, or restoration, modification or adaptation of a medical device prior to its commercialization and its release as a finished product, regardless of whether these operations are carried out by the same entity or by a third party.
• Real Manufacturer: Entity in charge of manufacturing, assembling, or remanufacturing a medical device (may be a subsidiary of the legal manufacturer), or contracted by the legal manufacturer to carry out manufacturing through a quality or contract agreement.

It is now clear that explanatory letters to COFEPRIS released by the manufacturer to further clarify the relationships between the entities are acceptable, when duly endorsed by the registration holder.

There are also several notes that confirm guidance documents in English are acceptable, but that information in other languages is required to be translated to Spanish (legal guidance documents require sworn translations).

All modifications to the registration conditions is required to be requested by the registration holder. The holders of the health records, through their legal representative, is required to promote the procedures before this Commission corresponding to the request for modifications to the health registration conditions of the Medical Device, using the official formats.

The following modifications, but not limited to, as they are related to the safety and efficacy of the product, require the submission of the request for authorization of a new registration by COFEPRIS:

• When there are modifications in the pharmaceutical form or physical presentation.
• When there is a substitution of the active ingredient or modification of the material in its case.
• When new models of Medical Devices present technological advances that modify the main purpose of use, for which it was authorized.
• When there are modifications in the components or parts of the product that affect the functionality or purpose of use thereof.
• Any modification or modification that is made to the conditions under which the health registration was approved and that modifications the purpose and indication of use will require a new health registration.

Significant modifications to the New COFEPRIS Guideline

The most significant modifications to the new guidelines are:

• Product Formulation Changes (in particular modifications of active ingredients), physical presentation, modifications of raw materials, technology advances, modifications of components that have an impact on the functionality or intended purpose of the device, and modifications that represent an alteration of the intended use will require a new registration.
• The original registration route will need to be maintained through subsequent modifications, so guidance documentation will need to be supplied consistently (i.e., a model addition modification for a Health Canada registration, will require a Health Canada license, instead of any other Certificates of Free Sale (CFS) available to the manufacturer in other markets, such as a US Food and Drug Administration (FDA)-released Certificate to Foreign Government, or CFG)
• It is significant to ensure that the registration route selected is optimal for the device throughout its product life cycle.

Administrative modifications COFEPRIS-2022-022-003:

• Change of address of the local or foreign distributor.
• Change of company name of the registration holder, manufacturer or distributor.
• Change of distributor.
• Change of company name of the legal manufacturer.

The below were formerly considered as technical modifications that now included in Administrative Modifications

• Change of company name and address of the legal manufacturer.
• Change of commercial name or product catalog number.
• Change of secondary packaging material.
• Removal of sales presentations.
• Removal of distributors and/or manufacturer.

Technical modifications to the COFEPRIS-2022-022-004:

• Change of manufacturing sites of the national or foreign manufacturer.
• Change of contract manufacturer.
• Reclassification of the medical device based on the level of health risk.
• Change of primary and secondary packaging material.
• Change of shelf-life or Expiry Date.
• Model additions that do not represent technological advances nor modify the main intended use.
• Change of Formulation.

Modifications to the transfer of rights within the COFEPRIS-2022-022-005:

• Change of the registration holder.
• The guideline states that when the Mexico Registration Holder (MRH) is listed as importer or distributor, rights transfer modifications may also tolerate modifications to the importer and distributor section of the registration, as long as this is reflected on the label design and the modification encompasses the necessary representation letters for the supply chain participants. This apparently confirms that distributor modifications are once again accepted under rights transfer modifications.

Changes to guidance documentation and definitions

The guidance document obligations remain largely unmodificationd, but the definitions are revised to reflect the concepts listed in the Medical device supplement 5.0.

A few additional updates:

• Address updates resulting from street, city or zip code renaming conducted by government mandate, will require guidance documentation released by the authorities showing evidence that such is the case, or alternatively evidence of the notification to the notified body from the manufacturer to perform the address update on their Good Manufacturing Practice (GMP) certification.
• Address or company name modifications for the legal manufacturer will now require revised legalized representation letters released by the manufacturer to the registration holder and distributors.
• Legal manufacturers may be added even without a CFS (or equivalent), as long as there’s guidance documentation evidence of the relationship between stakeholders.
• Legal guidance documents shall be less than 30 months old when their validity periods haven’t been specified.
• It has been outlined that whenever a CFS is a requirement, it is required to contain the product’s commercial name/trade name, models, list of codes and the manufacturer information.
• All the information required on a Certificate of Analysis (when required) is clearly outlined, including examples of other standard guidance documentation that may fulfill this requirement (DHR, BPR, FIR, SFP).
• Modifications for registrations of condoms will require certificates of analysis released by local laboratories. Requirements for shelf-life modifications include precise details reflecting the recent updates to the Supplement.
• Formulation modifications is required to submit a formulation statement signed by the responsible quality representative, stability or aging studies, and Certificates of Analysis.
• There is confirmation that e-signatures are acceptable