La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) published in the Diario Oficial de la Federación on 10/05/2023 the update of the requirements for the renewal of the registration and for the submission of any post-registration changes of the medical device.
Concerning the requirements for renewing the registration of a medical device, it is stated that applications will be confirmed by a simple notification demonstrating the timeliness of the submission. The issued notification must be submitted together with the reference registration and retains the same registration number. The renewal process can be carried out electronically.
The process for communicating post-registration changes to the Mexican Regulatory Authority varies according to the nature of the change to be made: administrative or technical. Administrative changes refer to transfers of rights, change of name or address of the foreign distributor and change of legal manufacturer and must be communicated by letter issued by the manufacturer within a period not exceeding 30 working days from the date on which the transfer agreement, change of name or address of the foreign distributor took place.
Technical changes, on the other hand, concern a change of production site or the creation of new production sites, a change of classification of the medical device and a change of the expiry date. The notification of the change of production site or the creation of new production sites must specify the new references in detail, including information such as company name and address. On the other hand, the change of device classification must be supported by a risk assessment, and the change of expiry date must include real time shelf-life tests, in accordance with the requirements of NOM-241-SSA1-2021.
By simplifying the procedure for handling renewals and post-registration changes, COFEPRIS thus demonstrates its intention to increase the interest of manufacturers to market their Medical Devices in Mexico, guaranteeing users and patients the best care with the most advanced devices.
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