June 2, 2023
By Pedro Omar Sánchez Neri
Mexico’s Ministry of Health has updated its requirements for medical device registration grouping.
This Regulatory Update on the recently released 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), reviews changes to Appendix IV, the grouping criteria for medical device registrations.
This appendix did not change much. Changes were the following: wording and punctuation, added examples to better address the grouping of IVDs, rearranged the grouping criteria for surgical instruments (now contained under the medical equipment category), and added specific criteria for dental supplies.
Changes to the registrations of kits and systems
Although the concept of the kit was referenced for IVDs in the previous edition of the Suplemento, kits were not defined. Kits are now described as the sales configuration of two or more different types of medical devices under the same packaging, meant for a single diagnosis or medical procedure. The classification of the kit will be based on the highest risk component, and all individual components must be identified on the label.
The specifications for IVD kits state that in cases where the storage temperatures are not identical for all components, the label design will need to include the storage conditions for the entire kit along with the shelf life.
In the Surgical and Healing Material and Prosthesis and Functional Aids section, the sentence which addresses the registration of systems now includes the definition of system. A system is identified as a combination of devices (may or may not be contained in a single package) meant to be interconnected or combined in order to perform a specific intended use. It is also confirmed that products identified as a system may be registered together. (This also applies to the devices described below).
Changes to grouping criteria for IVD registrations
Further details for culture media state that grouping is allowed as long as culture media has the same intended use and the same composition or formula and physical aspects. Dehydrated media, prepared and semi-prepared, in tube or dish, with the same intended use for the selective media may be registered together. The unprepared culture media supplements that are necessary to fulfill their indication for use may also be included in the same registration.
Changes to the grouping criteria for certain medical device registrations
The grouping criteria for surgical instruments is now included under the medical equipment category (consistent with the classification criteria from Appendix II) and includes minor wording changes to confirm that different types of instruments may be grouped together as long as they are manufactured with the same raw materials and share the same intended use or surgical technique.
The new criteria for dental supplies states that these products may be grouped, provided the same intended use or dental surgical procedure and the same raw materials (plastics, polymers, elastomers, metal mechanics and glass/ceramics) are used. Formulated devices may be grouped as long as the main active ingredient is identical. The concept of system is also applicable here, and dental supplies may be grouped together as a system if they comply with the aforementioned definition.
Changes to general criteria for medical device registrations
The contents of this section remain unaltered, with the exception of Section 7.1.3. The previous statement endorsed the grouping of products destined for different commercial partners as long as the same commercial name was maintained, is now eliminated. It has been replaced with a statement confirming that grouping systems under the same secondary packaging with a specific medical purpose is permitted. The final notes were also edited to remove the statements which referenced “Verification Lists” of technical and legal document requirements for registration and renewals. Note that these Verification Lists were never made available on the COFEPRIS website.
The 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 the Supplement of Medical Devices 5.0 will be in effect). While the updates to Appendix IV represent minimal changes, the inclusion of new concepts, new grouping criteria for dental supplies and the reordering of surgical instruments within their proper category will reduce confusion from the previous version of Appendix IV.
Emergo by UL will consider these changes and prepare sanitary registration submissions, analyzing the best grouping strategy for its customers.
Pedro Omar Sánchez Neri is Consulting Manager, Mexico at Emergo by UL.
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