Mexico: Modifications to Medical Device Registration

In August 2023, the Mexican regulatory authority for medical devices, COFEPRIS, released an updated guidance document that clarifies the types of product and organizational changes and their potential impact on premarket medical device registrations. Prior to this publication, COFEPRIS had issued a statement introducing new classification criteria for modifications to sanitary registrations for medical devices.

These updated classification criteria became effective on August 28, 2023, replacing the criteria that had been implemented in February 2022. On August 9, COFEPRIS also published additional guidance explaining how to identify the applicable modification categories and outlining the requirements associated with each type of modification. The document also details the submission procedures and specifies the documentation required for modifications to the health registration of medical devices. A key update is that all modification requests must now be submitted electronically.

Revised COFEPRIS rules for modifications to sanitary registrations

The guidance begins by clarifying the definitions of “Legal Manufacturer” and “Real Manufacturer.”

• Legal Manufacturer: The natural or legal entity responsible for the safety, quality, performance, design, manufacture, conditioning, or assembly of a medical device system, including its restoration, modification, or adaptation before commercialization and release as a finished product. These responsibilities apply regardless of whether the activities are performed by the entity itself or by a third party.
• Real Manufacturer: The entity responsible for the actual manufacturing, assembly, or remanufacturing of a medical device. This organization may be a subsidiary of the legal manufacturer or an external party contracted through a quality or contractual agreement to perform manufacturing activities.

The guidance also confirms that explanatory letters submitted to COFEPRIS by the manufacturer are acceptable for clarifying relationships between involved entities, provided they are endorsed by the registration holder.

Additional notes indicate that documents written in English are acceptable. However, documents in languages other than English or Spanish must be translated into Spanish. Legal documents specifically require sworn translations.

Any modification to the conditions of an existing registration must be requested by the registration holder. Registration holders, acting through their legal representatives, must submit modification requests to COFEPRIS using the official formats established by the authority.

Certain modifications, particularly those related to the safety and effectiveness of the device, require the submission of an application for a completely new registration. Examples include:

• Changes in the pharmaceutical form or physical presentation of the device.
• Replacement of an active ingredient or modification of materials used in the product.
• Introduction of new device models that incorporate technological advances affecting the primary intended use for which the device was originally authorized.
• Changes to components or parts that influence the device’s functionality or intended purpose.
• Any modification to previously approved registration conditions that alters the device’s intended use or indications.

Significant changes to the New COFEPRIS Guideline

The updated guideline introduces several important changes. For example, modifications involving product formulation (especially changes to active ingredients), alterations to physical presentation, changes in raw materials, technological improvements, and modifications to components that affect functionality or intended purpose will now require a new registration. Any change that alters the intended use of the device also requires a new sanitary registration.

Another important requirement is that the original regulatory pathway used for the device registration must be maintained for future modifications. Consequently, supporting documentation must correspond to the same regulatory authority used during the original submission. For example, if a device was initially registered using a Health Canada license, any model additions must continue to use Health Canada documentation rather than other available certificates such as a Certificate to Foreign Government issued by the U.S. Food and Drug Administration.

For this reason, it is essential for manufacturers to carefully select the most appropriate registration pathway for the entire lifecycle of the product.

Administrative modifications COFEPRIS-2022-022-003:

Administrative modifications include:

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

Certain changes that were previously categorized as technical modifications are now considered administrative modifications, including:

• Changes to the legal manufacturer’s company name and address.
• Changes to the commercial name or product catalog number.
• Changes to secondary packaging materials.
• Removal of specific sales presentations.
• Removal of distributors or manufacturers from the registration.

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 supplement5.0.

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.