Mexican Regulators May Allow Third-Party Reviews of Medical Devices
Mexico’s medical device regulator COFEPRIS is considering utilizing third-party reviewers to speed up submissions under the standard registration process.
In mid July, the regulator published a notice to interested companies to apply within 30 days for consideration to be designated third-party reviewers. Class I, II and III device registration submissions would be eligible for third-party review according to the notice.
Firms applying to serve as third-party reviewers for COFEPRIS must meet five general requirements.
First, application forms must be submitted to COFEPRIS within 30 days of the notice’s publication.
Second, applicants must be legally incorporated under Mexican law, or in the case of individuals, naturalized Mexican citizens.
Third, applicants bust provide written attestation under oath that their products, processes or services comply with Mexican Standard NMX-EC-17020-IMNC-2000.
Fourth, applicants should meet the requirements of Article 211, Section II of the Rules of Inputs for Health in terms of having the technical and financial resources—including liability insurance—to properly conduct third-party reviews and inspections.
Fifth, applicants must be under no direct influence of any manufacturer, importer or other party that could cause conflicts of interest regarding registration reviews.
If COFEPRIS ultimately does implement a third-party review system for standard medical device registrations, the move would add additional efficiencies to the Mexican device registration process and further increase the market’s appeal to foreign manufacturers.