SERVICES
Sanitary Register of Medical Devices, class I, II and III
Sanitary Authorization, which the Medical Devices must have (for whatever their classification turns out to be).
Granted by the local Ministry of Health, which will exercise the powers of regulation, control and sanitary promotion through the COFEPRIS
Renewal of Sanitary Registrations of Medical Devices, class I, II and III
Renewal of the Official Document corresponding to the Sanitary Registration of Medical Devices, after the expiration of the term granted in the authorization, as long as the conditions under which they were granted, do not change for a Sanitary Register of Medical Devices (for any classification). *DIGIPRIS modality.
*COFEPRIS constantly innovating, so they have developed a digital method to speed up procedures and have digitalised some of the applications, including this procedure.
Operation Notice and Health Responsible Notification
Mandatory administrative document for establishments, where the activities and products carried out in the establishment are declared.
Advertising notices for health care professionals.
Notice that any entity submits before COFEPRIS to inform about any service or product to be offered.
Registration of the Technovigilance Resposible and Technovigilance Manager
Development and implementation of procedures and activities related to medical device vigilance. Advertising Notices for Health Professionals. Notice that a natural person delivers to COFEPRIS, through which they inform about the service or product offered.
Sanitary Import Permit for Medical Devices
An administrative act by which the Health Authority allows a public or private person to import health supplies by issuing a permit. (This permit only lasts 6 months, so they are constant forwarding procedures.)
REGULATORY ADVICE SERVICE
Get your approval before COFEPRIS
LICENSES AND PERMITS
We advise you to reduce approval times
REGULATORY ADVICE SERVICE
We have a multidisciplinary team, which generate specific strategies for each of our clients. This guarantees an entire advice on sanitary regulation.
Achieve your goals with us!
At SGR Especializada
- We have all the experience to provide you with the most complete and specialised advice.
- We build strategies based on sanitary regulation to you can achieve your objectives as soon as possible.
What we do in SGR?
REVIEWS
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Expert Support
Make sure your product complies with legal standards!
We have strategies to get your product approved in the shortest time possible, complying with all the requirements.
CONTACT US
Expert Support
Make sure your product complies with legal standards!
We have strategies to get your product approved in the shortest time possible, complying with all the requirements.
Get more information