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

Before that COFEPRIS issued a statement announcing that new classification criteria for modifications of sanitary registrations for Medical Devices. The new classification criteria will be effective from August 28, 2023, replacing the previous criteria implemented in February 2022. Following that COFEPRIS published on August 9’th that provides some important details related to identifying the criteria and requirements for the modification of sanitary registrations, submission process, specifying the description of the requirements 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 document clarifies 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 issued 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 documents in English are acceptable, but that information in other languages must be translated to Spanish (legal documents require sworn translations).

All modifications to the registration conditions must be requested by the registration holder. The holders of the health records, through their legal representative, must 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 changes in the pharmaceutical form or physical presentation.
• When there is a substitution of the active ingredient or change 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 changes in the components or parts of the product that affect the functionality or purpose of use thereof.
• Any modification or change that is made to the conditions under which the health registration was approved and that changes the purpose and indication of use will require a new health registration.

Significant changes to the New COFEPRIS Guideline

The most important changes to the new guidelines are:

• Product Formulation Changes (in particular changes of active ingredients), physical presentation, changes of raw materials, technology advances, changes of components that have an impact on the functionality or intended purpose of the device, and changes 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 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)-issued Certificate to Foreign Government, or CFG)
• It is important 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 mentions that when the Mexico Registration Holder (MRH) is listed as importer or distributor, rights transfer modifications may also tolerate changes to the importer and distributor section of the registration, as long as this is reflected on the label design and the modification contains the necessary representation letters for the supply chain participants. This apparently confirms that distributor changes are once again accepted under rights transfer modifications.

Changes to documentation and definitions

The document requirements remain largely unchanged, but the definitions are updated 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 documentation issued 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 changes for the legal manufacturer will now require updated legalized representation letters issued 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 documentation evidence of the relationship between stakeholders.
• Legal documents shall be less than 30 months old when their validity periods haven’t been specified.
• It has been defined that whenever a CFS is a requirement, it must 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 defined, including examples of other standard documentation that may fulfill this requirement (DHR, BPR, FIR, SFP).
• Modifications for registrations of condoms will require certificates of analysis issued by local laboratories. Requirements for shelf-life modifications include precise details reflecting the recent updates to the Supplement.
• Formulation changes must 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.