COFEPRIS Mexico Medical Device Postmarket Compliance
Postmarket compliance requirements for medical devices include import permits, renewals, and technovigilance.
Mexico postmarket requirements for medical devices
Once you obtain your Sanitary Registration from COFEPRIS to legally sell your device in Mexico, your regulatory obligations are far from over. Your Mexico Registration Holder (MRH) is an essential figure in your postmarket compliance activities, as only legal residents can submit documents or communicate with COFEPRIS. You also benefit from your MRH's expertise, as they should have experience communicating with COFEPRIS, following their official processes, and coordinating the documentation and systems you need to maintain compliance.
Your MRH is responsible for three key activities to ensure the continued legal sale and distribution of your device:
- Applying for and maintaining valid import licenses for your device;
- Applying for modifications and renewals of your Sanitary Registration;
- Maintaining a postmarket surveillance and vigilance system (i.e., technovigilance) to monitor the safety and effectiveness of your device.
How to obtain a medical device import license in Mexico
You need an import license from COFEPRIS to legally import your device to Mexico, even if you already have a Sanitary Registration Certificate for your device. COFEPRIS issues different types of import licenses, including import licenses for devices with valid registrations. Import licenses are valid for up to 180 days or for a quantity of devices to be imported. When the terms of the license are exhausted, you must apply for a new license, which can take 3-4 weeks. As such, it’s essential that your MRH monitors the terms of your current license and applies for new licenses on time to avoid any potential disruptions in importation and distribution.
Medical device postmarket surveillance and vigilance in Mexico
Establishing a technovigilance system, which is called postmarket surveillance and vigilance in other markets, is a requirement outlined in NOM-240. Technovigilance is designed to monitor the safety and performance of your device and requires timely reporting of incidents related to your device performance. Under Mexico’s technovigilance requirements, your MRH is primarily responsible to report incidents and adverse events related to your device to The National Center of Pharmacovigilance (CNFV), though manufacturers and distributors are also expected to report. Not all incidents must be reported. However, adverse incidents that result or could result in a death, serious deterioration of health, or public health threat must be reported according to specific timelines based on the circumstances of the event.
Renewals
A renewal of your COFEPRIS medical device registration is also known as an extension. Extensions are initiated with a digital application and the first extension should be submitted at least 150 days before your registration’s expiration date. The first extension requires the following documentation:
- Application and application fee
- Power of Attorney
- Technovigilance Report
- Representation letter
- GMP certification or equivalent (such as an ISO 13485 certificate)
The initial extension is the most labor and time intensive. Subsequent extensions require less paper and processing time.
Frequently
Asked Questions
What is a Technovigilance Unit (TU)?
The technovigilance unit is the physical location where your technovigilance activities take place. Your MRH must establish a technovigilance unit and it must be operated by someone who is well-versed in the requirements of NOM-240 and technovigilance processes.
What is a technovigilance report?
The technovigilance report is a summary of your technovigilance activities, including incidents, a summary of your findings from investigating the incidents, and the corrective actions you deployed in response. The technovigilance report must be maintained, as it is a documentation requirement to process a first renewal of your COFEPRIS registration.
What kinds of medical device incidents do not require notification to CNFV?
There are times when an adverse event might occur but you are not required to notify COFEPRIS. For instance, if the device was expired when the use or malfunction caused the event. Or, if it is determined that the patient’s illness caused the adverse incident. However, it’s important to carefully document your findings and corrective actions following all incidents, even if you do not report them, in case you need to justify your decision not to report an event.
