Nowadays, there is a growing range of new products intended for the diagnosis, monitoring, prevention, rehabilitation, surveillance in the treatment of diseases in humans or auxiliary in the treatment of them and disability, as well as those used in the replacement, correction , restoration or modification of human anatomy or physiological processes, which must demonstrate quality, safety and functionality, for which COFEPRIS requests a Sanitary Authorization (Marketing Authorization) for its commercialization in the national territory, for this it is required the submission of a dossier with all the information about of the Medical Device that complies with the current Sanitary Regulation.
At GMVR, we support you throughout the process of compiling and reviewing the Medical Devices (Medical Equipment, Prosthetics, Orthotics and Functional Aids, Diagnostic Agents, Dental Supplies, Surgical and Healing Materials, Hygienic Products and Software as a Medical Device) dossier for submission to COFEPRIS, we have the following services:
- New Register
- Conventional Submission: Class I, Class II, Class III
- Equivalence Agreement: U.S.A. (FDA), Canada (Health Canada) and Japan (MHLW), Class I, Class II, Class III
- Variations
- Technical Variation
- Administrative Variation
- Change of Sanitary Register Holder
- Renewal of the Register