Background
Obtaining a Sanitary Registration for a medical device in Mexico is a complex process that may take from months up to years. Thus, once obtained, it is very important to maintain those authorizations valid. Specifically, being aware of when to renew them, when to request an amendment through an administrative or technical modification or simply understand the rights transfer process and their stakeholders.
In some cases, it can be necessary to perform successive modifications or renewals that may overlap because of delayed responses from the authority. Such cases may lead to a solution that is controversial: requesting a Sanitary Registration for a product already approved in Mexico. In other words, registering the same medical device twice or even more times.
In this article, we will explain the legal framework around such process, some examples when it is common to do it and our comments.
Legal framework
Although Mexican regulations consider different scenarios, particularly for sanitary authorizations, there is still a gap for registering the same medical device.
The closer approach for not registering the same product twice is the Article 23 of the Health Supplies Regulation, but it only refers to distinctive denominations (trademark or brand names). Specifically, it clearly states that the same brand name can be registered separately if manufactured by the same entity and is presented in different versions or presentations.
It is worth mentioning that even though such article in the law refers to pharmaceutics, it is inferred that is also applicable for Medical Devices.
Examples
Considering there is not a clear legal framework, we have found some cases when manufacturers have used it:
- Errors in the Sanitary Registration that cannot be supported by the current documentation
- Renewals not requested or issued on time
- The sanitary registration holder is a company that does not exist anymore
- Expensive fees set by the Holder for transferring rights
- The Manufacturer wants to hold the registration or chose different distributors
- Different distributors need to have their own registrations for different purposes
- A technical modification that is not considered in the cases mentioned in the regulation
Conclusion
There are many other situations when it is extremely necessary to request the Sanitary Registration for the same medical device more than once. If you are under cases similar than those exemplified in this article, it is recommended to request different distinctive names to justify the need of different registrations.
Once each approval is obtained, it is essential to perform traceability of which registration was used to import each device and to accomplish with proper labeling and technovigilance.
If you have additional questions about when to request a sanitary registration of an already approved medical device in Mexico, please contact us at contact@veraqueconsulting.com or visit our guidelines.
