Introduction
Last November the 18th 2020, the Ministry of Health in Mexico released a note through the Official Diary establishing new expedited timelines for medical devices and pharmaceutical supplies registration approvals.
This is not the first time the government tries to improve the official time responses. Nevertheless, different circumstances as the international UNOPS bid has exerted pressure to provide unprecedented measures. In this case, the authority is reporting 5 working days to resolve any new registration request under the equivalency agreements.
How this process is going to work is still uncertain, because the amount of paperwork seems to be the same and in our experience it takes time to any agency to adapt, particularly to such abrupt announces.
In this article we explain more details about the timelines and its conditions, and some key points that could help you to better understand this document and how to take advantage of what it might be the fastest regulatory pathway in Mexico.
As a note, in this article we are focusing on medical devices and not on pharmaceutical supplies.
Timelines
The big conclusion about this official note is that COFEPRIS will take 5 working days to resolve any new registration request under the equivalency agreement and if it is not resolved under that period of time, the application must be considered as granted. To provide a better perspective, upon the release of this note, the authority must respond in 30 to 60 days any new medical device registration request. Nevertheless, as mentioned in the RA guide, it could take more than 1 year to receive feedback.
Looking for alternatives, in 2010 and 2012, the government released the equivalency agreement that should be an option to expedite the processes, recognizing approvals from the FDA, Health Canada or the Ministry of Health Welfare and Labor in Japan. Such agreement stated that 30 working days would be the timeframe to respond new registrations or any other type of processes under this agreement. Again, in practice 6-8 months were the timelines the authority ended up responding.
As we will further explain in the next section, the equivalency agreement route is not strictly an immediate recognition of the approvals in the mentioned countries (USA, Canada, Japan). Therefore, it is very important to carefully evaluate if you are eligible for such regulatory route.
Finally, in our experience, when the first equivalency agreement announcement in 2010 were released, submissions were approved in 2-3 months upon submission. Such rate increased after some years to end up at 6-8 months until third party reviewers were considered the fastest route.
Key points to consider
This announcement sounds appealing but you must be careful about your eligibility for the equivalency route. These are some of the key points to consider:
- The equivalency route is not applicable for Class I Medical Devices approved in Health Canada and the MHWL in Japan.
- Even though Class I, II and III FDA approved medical devices are eligible for the Equivalency route, the Establishment Inspection Report (EIR) is a requirement. In our experience, this is not a document easily released to any type of medical device manufacturer.
- In case your company is not located in one of these countries (USA, Canada or Japan), you are still eligible for the equivalency agreement if you are approved by FDA, HC or the MHLW. Nevertheless, the legalization process might be a challenging requirement to resolve.
We also provide some hints in our equivalency agreement article if you need further details.
Conclusions
Even though the latest Ministry of Health announcement improves the timelines in COFEPRIS, we strongly suggest to be cautious in your projections. Nevertheless, in our experience with the first equivalency agreement, we found that the first submissions under such agreement were responded faster than the timelines we are experiencing today.
In other words, this could be a temporal advantage for medical device manufacturers looking to develop the Mexican market. And what we mean by temporal is that there are not guarantees on how COFEPRIS is going to deal with the immediate demand. We will be keeping you updated on any new release.
In case you have any question about this process, please feel free to send us an email at contact@veraqueconsulting.com or visit our guides for the most updated news about the regulatory affairs medical device sector in Mexico.
