- Get in the international market for Medical Devices, we are experts in regulatory management.
- Sign up for workshops with curricular certification, learn how to create the best strategies
Get in the international market for Medical Devices, we are experts in regulatory management.
Sign up for workshops with curricular certification, learn how to create the best strategies
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.)
We are your regulatory partner
Get your approval in record time
OTHER SERVICES
Dossier compilation
We have expert staff for the preparation of dossiers for different Ministries of Health.
In Mexico, we are leaders in obtaining Registrations through traditional procedure, and through Equivalence Agreements with Japan, Health Canada and the FDA.
Courses
We have developed training programs in sanitary regulation, medical device and drug dossier preparation, technovigilance, Legal framework., as well as standard operating procedures, export and import of health supplies, food, food supplements, cosmetics, etc.
We participate in training sessions with Medical Associations and Chambers.of Commerce.
Dossier compilation
We have expert staff for the preparation of dossiers for different Ministries of Health.
In Mexico, we are leaders in obtaining Registrations through traditional procedure, and through Equivalence Agreements with Japan, Health Canada and the FDA.
Courses
We have developed training programs in sanitary regulation, medical device and drug dossier preparation, technovigilance, Legal framework., as well as standard operating procedures, export and import of health supplies, food, food supplements, cosmetics, etc.
We participate in training sessions with Medical Associations and Chambers.of Commerce.