In a significant regulatory update, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has introduced new guidelines for medical device registrations. The changes, which came into effect in August 2023, aim to streamline the review process and address the backlog of applications.
New Classification Criteria The revised guideline, released in response to OFICIO-CFS-325-2023, establishes fresh criteria for the modification of sanitary registrations of medical devices. This includes a clear definition of terms such as ‘Legal Manufacturer’ and ‘Real Manufacturer,’ ensuring clarity in the application process.
Electronic Submission A notable shift is the move towards electronic submission of modifications. Applicants must now submit changes electronically, albeit in person, using a marked USB flash drive.
Impact on Manufacturers Manufacturers must ensure that the original registration route is maintained through subsequent modifications. The guideline emphasizes the importance of selecting the best registration route for the device throughout its lifecycle.
Global Implications These updates by COFEPRIS are expected to have a positive impact on the medical device industry, both domestically and internationally, by expediting the registration process and bringing innovative medical devices to the market more swiftly.
COFEPRIS rules for changes to the health register
In response to OFICIO-CFS-325-2023, COFEPRIS issued a revised guideline on August 9, titled “Gua De Criterios Para Clasificación de Modificaciones de Registros Sanitarios de Dispositivos Médicos.” This guideline establishes the criteria and procedures for modifying sanitary registrations of medical devices.
The guideline begins by referencing the existing regulatory framework, which includes the General Health Law, Health Supplies Regulation, Mexican Pharmacopoeia, and subsequent agreements published in 2011, 2015, and early 2022. It aims to clarify the modification requirements by defining key terms:
Legal Manufacturer: The natural or legal person responsible for the safety, performance, quality, design, manufacture, conditioning, assembly, restoration, modification, or adaptation of a medical device before its commercialization. This responsibility applies regardless of whether these operations are carried out by the same entity or a third party.
Real Manufacturer: The entity responsible for manufacturing, assembling, or remanufacturing a medical device. This may include subsidiaries of the legal manufacturer or entities contracted by the legal manufacturer through quality or contract agreements.
Notable Revisions in the New COFEPRIS Guideline:
Product Formulation: Changes related to the pharmaceutical form or physical presentation of the medical device.
Maintenance of Original Registration Route: Subsequent modifications must maintain the original registration route.
Optimal Registration Route Selection: Manufacturers should select the most suitable registration route for the device throughout its life cycle.
These revisions aim to streamline the modification process and enhance clarity for medical device registrations in Mexico
COFEPRIS-2022-022-003-A (Administrative Modifications) for Homoclaves
The Administrative modifications under homoclave COFEPRIS-2022-022-003-A pertain to changes related to the registration of medical devices in Mexico. These modifications include:
Change of Address:
This applies to either the local or foreign distributor.
Change of Company Name:
It can be for the registration holder, manufacturer, or distributor.
Change of Distributor:
Refers to a change in the authorized distributor within the national territory.
Change of Legal Manufacturer’s Company Name.
These administrative modifications are part of the process for maintaining and updating medical device registrations. If you need further details or assistance, feel free to ask!
Technical modifications to the COFEPRIS-2022-022-004-A Homoclave
The Technical modifications under the COFEPRIS-2022-022-004-A homoclave include the following changes to medical device registrations in Mexico:
Change of manufacturing sites: This applies to both national and foreign manufacturers. If the manufacturing sites are branches or subsidiaries, modifications can be made.
Change of contract manufacturer (maquila): If there is a need to switch contract manufacturers, this modification is allowed.
Reclassification of the medical device: The level of health risk associated with the device can be reclassified.
Change of primary and secondary packaging material: Modifications related to packaging materials are permissible.
Change of shelf-life or expiry date: Adjustments to the expiration date of the medical device are also covered.
These guidelines aim to streamline the review processes and eliminate backlogs in the
COFEPRIS system
COFEPRIS-2022-022-004-A homoclave, Technical modifications:
The Technical modifications under the COFEPRIS-2022-022-004-A homoclave include the following changes to medical device registrations in Mexico:
Change of manufacturing sites: This applies to both national and foreign manufacturers. If the manufacturing sites are branches or subsidiaries, modifications can be made.
Change of contract manufacturer (maquila): If there is a need to switch contract manufacturers, this modification is allowed.
Reclassification of the medical device: The level of health risk associated with the device can be reclassified.
Change of primary and secondary packaging material: Modifications related to packaging materials are permissible.
Change of shelf-life or expiry date: Adjustments to the expiration date of the medical device are also covered
COFEPRIS-2022-022-005-A homoclave, Transfer of Rights Modifications:
Modifications to the transfer of rights within the COFEPRIS-2022-022-005-A homoclave include the following:
Change of registry holder: When the Mexico Registration Holder (MRH) is listed as an importer or distributor, changes to the transfer of rights can also tolerate changes to the section of the registry relating to the importer and distributor.
To learn more about changes in Medical Device Regulations by COFEPRIS and their impact on your products, please get in touch with our Mexico medical devices regulatory expert team.