Clases of medical devices and grouping criteria

Classes: In Mexico there are 4 classes for Medical devices:

• IA – Low risk - there is a specific list and the device must be listed to be in this classification.
• I - Mainly external products – not sterile, per example: hygienic products
• II - Sterile or invasive that stays in the body or in contact with the patient for less than 30 days
• III - Invasive that stays in the body or in contact with the patient for more than 30 days. Includes all implants. High risk products.

Classification/grouping is according to Mexican criteria and ruling, despite the classification in the country of origin. If you have any doubt please contact us and we will help you to determine the classification for your medical devices. Grouping criteria: In Mexico, as in many countries, you can register a family of products together, if they comply with the grouping criteria from Cofepris, which a Grosso modo are the following. The products to be grouped must have:

• The same manufacturer
• Same class (according to Mexican classification)
• Same intention of use (final indication) and technology (new technology is new registration)
• Same materials or formulation (same active ingredients)
• Consider that all that can be sold apart must be registered apart (p. e. consumables, if they will be imported independently, they will need a separate registration)

Final criteria are always from Cofepris. If you have any doubts about how to group your product please contact us and we will be happy to help. We will be discussing in the future the specific requirements for registration, among other updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.