June 2, 2023
By Daniela Sánchez Gálvez and Pedro Omar Sánchez Neri
Mexico’s Ministry of Health has updated its requirements for medical device registration renewals and modification submissions.
This Regulatory Update on the recently released 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), complements the previous update on Appendix III, and discusses the modifications and renewals to medical device “Sanitary” registrations. While the two categories of modifications, administrative and technical, still exist, there are changes to these types. Sanitary registrations are still valid for five years. Hence, renewals are still required, and there are updates to the process.
All submissions to COFEPRIS are issued a submission key (or homoclave), which provides data on the year of submission, as well as a code for the route of the submission and type of submission.
What are the changes once a manufacturer has been issued a sanitary registration for their devices?
Additional information is now required with a modification submission
An electronic version of the label design (Proyecto de marbete) must now be included with the submission of all types of modifications. Yes, this is in addition to the paper version.
Updates to Administrative Modifications
Rights Transfer: Article 190 of the Reglamento is hereby quoted, stating that the transfer must be communicated (through a complete modification submission), within a period not exceeding 30 business days from the date on which the transfer agreement took place.
Change of name or address for the foreign distributor: This change shall now be supported by a letter issued by the manufacturer acknowledging the foreign distributor’s changes.
Legal Manufacturer change (as long as the manufacturing conditions remain unaffected): Previously, this change was not identified. The requirements for this type of change are now defined.
Updates to Technical Modifications
Change of manufacturing site and authorization of new manufacturing sites: The requirements remain the same, but there is significant detail about acceptable alternatives. In addition, examples of acceptable legalization support each case.
Change of foreign contractor: This update includes details on the information that must be included on the manufacturing agreement between the manufacturer and the foreign contractor. The Certificate of Analysis or its equivalent is listed as a requirement (missed on the previous version of the Suplemento, although effectively requested by COFEPRIS).
Reclassification of the Medical Device: Modifications for reclassifications need to include a proper justification based on the risk assessment, with additional information in a document referred to as General Information. The contents of this document are now listed in this update.
Modification in the expiration date: The only difference is the long-term and/or accelerated aging studies must conform to the requirements of the NOM-241-SSA1-2021.
New presentations (not considered as technological advances that modify the principal intended use): This section was heavily revised to match the contents of several Agreements published by COFEPRIS, where Certificates of Analysis, GMP certificates and Free Sales Certificates were requested. In addition, a comparison table is now mandatory as well.
Updates to the requirements for registration renewal
This update includes the aforementioned updates of the Reglamento, and it now mentions the requirements for the first and second (or subsequent) renewals. COFEPRIS continues to issue approvals (after a 5-8 month review) for renewed Sanitary Registrations with extended validity (the registration is printed out with an extended validity for the next 5 years). However, second and subsequent renewals only get a receipt showing that the renewal has been submitted on time (approved immediately upon submission). For commercial and regulatory purposes, this receipt must accompany the last printed version of the Registration to show evidence that it has been renewed and hence remains valid. This section of the Suplemento effectively confirms that said receipt issued by the Ministry of Health for second and subsequent renewals will have the effect of the formerly renewed Health Registration, keeping the same assigned registration number. It is also confirmed that the renewal process may be carried out electronically (although in practice it is exclusively performed through this way).
These changes will become official on July 10 (60 calendar days after the publication of May’s 10th Notice on the Diario Oficial de la Federación, confirming when will the Supplement of Medical Devices 5.0 be in effect). The Ministry of Health’s agreement of January 24, 2022 confirms that the submission of renewals and modifications may be performed through the COFEPRIS digital platforms (when available). As of now, only renewals may be submitted electronically, although the homoclaves for modifications are already identified digitally, which suggests that the possibility of submitting modifications online is imminent, although not yet announced. Emergo by UL eagerly awaits the possibility to submit modification applications through this platform as well.
In the meantime, Emergo by UL will start including the new documents in its modification and renewal submissions.
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