Registration holder for medical devices

Why do you need one?

Cofepris only provides marketing approvals to companies legally established in Mexico, and with necessary infrastructure to uphold with the regulatory responsibilities.

If your company has no offices in Mexico, you will need to name a registration holder with an established address in Mexico, among other requirements. The registration holder is responsible of hosting and keeping your registrations so these can be imported and marketed in Mexico. Cofepris considers this holder to be the “owner” of the registration and the responsible of the product.

Traditionally, distributors are named holders; however, when you provide the authorization they will have complete control over the registration of the product and over how you can distribute it. So, if there were ever commercial disagreements or if the manufacturer wanted to recover the registration, it is impossible to do so without the distributor’s consent, which leads to loss of the registration in most cases.

Why choose us?

By naming RAFconsulting® your registration holder, you maintain complete control over your products and registrations, which models to include, and whom to name importer and/ or distributor of your medical devices, since we comply with every requirement of Cofepris, with the guarantee of being independent and having no distribution or product-commercialization activity whatsoever, so we have no conflict of interest. We specialize in taking care of your registrations, while your distributors directly import and have complete commercial independence, what they do best.