There are specific requirements for obtaining sanitary registrations of Medical Devices in Mexico. Those requirements can be found in the COFEPRIS website, in the National Catalog of Regulations, Procedures and Services and also in our checklist website.
In a previous article, we have explained the generals of labeling requirements for medical devices in Mexico, as well as the use of back-labels for foreign products.
In this article, we will go deeper on how to use and elaborate label designs and will introduce another useful non-mandatory requirement that is called registration design.
What are label and registration designs?
Label and registration designs are draft documents written in text processor that contains the information that the actual label, back-label (label designs) and the Sanitary Registration (registration designs) must contain. Moreover, these word files are included in a CD or USB for the use of COFEPRIS reviewers, providing them with a source of information that can be copied to reduce time of transcription, avoiding typos.
How to create a label design?
To create a label design, first we need to identify the current label of the medical device that will be registered. If you are including a group or family of medical devices in a single registration, you must create a generic label that can be applicable for all the codes to be registered.
What must be included in a label design?
You can refer to the section “Back-label, over-label or secondary label” in our previous article and if more detail is needed, to the local standard NOM-137-SSA1-2008, (Medical Device labeling norm).
How to proceed if a product has different labels?
We can consider the following cases:
- Products with primary and secondary packaging (individual or collective). Each packaging with different labeling.
- Products with labeling over the medical device and labeling on primary packaging.
- Kits of different types of products, each one with a different individual labeling and a collective label.
In all cases, we must include a label design for each label included in the products.
When to include a registration design?
As referred, a registration design describes what the Sanitary Registration should include. Even though it is not mandatory, it clarifies to COFEPRIS how the Sanitary Registration is being requested. For procedures requested through the COFEPRIS digital platform (Digipris), such as renewals, it is recommended to include the registration design as an optional requirement.
How to create the registration design?
Even though there is not a regulatory document on how to elaborate a registration design, all registrations for medical devices issued by COFEPRIS share the same layout. Therefore, we can suggest the following points to include, when applicable:
- Mexican Registration Holder (name and address)
- F.C. (Local Fiscal ID)
- Commercial and generic name
- Device type, per Art. 262 LGS (I.-V.)
- Device classification, per Art. 83 RIS (Class I-III)
- Manufactured by (name and address)
- Manufactured for (name and address)
- Imported by (name and address)
- Distributed in Mexico by (name and address)
- Intended Use
- Device description (and sterilization method)
- Presentations
- Primary and secondary packaging
- Shelf life
- Advertisement aimed to
Conclusions
Label and registrations designs are mandatory and optional requirements, respectively. However, both are important and recommended to be included in all registration requests as they provide an important source of information that will be included in the Sanitary Registration and back-label (if applicable).
Some medical devices can be complex because of their labeling or production chain, so we must elaborate proper label and registrations designs. If you need support with your drafts for these types of documents, please contact us at contact@veraqueconsulting.com or check out our checklists.
