If you have an approved medical device sanitary registration in Mexico, it is important to consider that any modification have a great significance in this authorization lifecycle. In this article, we explain in which cases is necessary to request a modification to COFEPRIS. This will help you to avoid problems during exportations or marketing activities.
When a modification is necessary
All sanitary registrations for medical devices are issued by COFEPRIS indicating the conditions to market the device. The health supplies regulation indicates that sanitary registration holders must submit the legal, technical and scientific information to support any changes in the following cases:
- Sanitary registration holder changes
- Authorized distributor(s) additions
- New distributor(s) legal address
- New manufacturer or distributor(s) company name
- New Manufacturing site (including third party manufacturers- OEM)
- New product sources (if the new source is a subsidiary or affiliated company)
- New device classification
- Primary or secondary packaging materials changes
- New or different shelf life or sterilization process
- New models or presentations of the product not involving technological advances (if so, a separate registration is required)
- New formula
- New or different commercial name/trademark or catalog/reference numbers
Any changes in the points 1-4 are considered as administrative modifications. Otherwise, modifications in points 5-12 are known as technical modifications. Finally, it is useful to consider that one or more conditions can be modified at a time.
It is worth mentioning that every sanitary registration is approved with a remark stating that the granted authorization can be revoked if terms and conditions are changed. Considering the scope of this remark, and if none of the 12 points mentioned are applicable to your case, our recommendation is to look forward if the authorization in the country of origin has changed. If it is not the case, most of the times, no modification is necessary in Mexico either. If you are not sure, feel free to give us a call to provide a more accurate advice.
When a modification is not applicable and a new registration is required
In case there are modifications in the product related with safety and effectiveness of the medical device. Then a new sanitary registration must be requested. Specifically, the following are the conditions when a new registration is required:
- New pharmaceutical form or physical presentation.
- Different active pharmaceutical ingredient or medical device materials
- Technological advances modifying the purpose of use are presented.
- New components of the devices having impact in the indication of use
- Indication or purpose of use is changed
Some extra advices
During the modification process, you can only sell your medical devices under the approved conditions at that moment. For example, if you want to include a new model, you have to wait until the modification is approved and this new model is mentioned in the sanitary registration.
Keep in mind that changing some conditions may complicate its exportation to Mexico, especially those related to the product label. To get certainty of when and how to request a sanitary registration modification and be able to sell the product in Mexico, please contact us for more details at email@example.com