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The Mexican Regulatory Authority, COFEPRIS (The Federal Commission for Protection against Sanitary Risk) has established a new electronic appointment system for medical device registrants for submitting applications or seeking in-person meetings with the Agency. This measure is a part of the digitization process and in compliance with the provisions of the Ministry of Health, to limit the number of visitors to the COFEPRIS facilities and reduce the risk of contagion by COVID-19.
As required by the Agency, all the users can utilize the new electronic appointment system by adhering to the following key criteria:
- The users must register in the new electronic system
- The users may request only one appointment per day
- The new electronic appointment system can be accessed with e-signature, or any other authentication mechanism determined by the Agency
- All the information on the procedures and specific services to be performed must be registered
- Users willing to cancel the scheduled appointment must inform the Agency at least 24 hours in advance
- All the fees related to appointments must be paid at least 48 hours ahead of the schedule
Alongside, the Comprehensive Service Center (CIS) facilities are incorporated with transparent acrylic protection covers at each window and a sanitary filter at the entrance. In addition, each executive must wear Personal Protective Equipment (PPE) and the applicants who arrive at the CIS facility must comply with the following provisions:
- A printed receipt of an appointment is a must
- As a mandate, users must put on face mask
- Access is exclusively given to users previously registered in the appointment system
- Users must present a valid official identification with photograph
- Users must show up 10 minutes before the time indicated in their appointment and failing to do so will lead to cancellation
- As stated in the appointment voucher, attention will be provided exclusively to the indicated person for the amount of procedures and services mentioned
- All procedures will be entered and processed in accordance with the applicable legal provisions
- Users can check the status of their request on the COFEPRIS portal
As the Mexican Regulatory body, COFEPRIS established a new electronic appointment system to reduce the risk of coronavirus exposure, the medical device stakeholders must ensure to comply with the Agency’s regulations for all the necessary Regulatory operations and procedural best practices. Stay safe. Stay informed. Stay compliant.
