COFEPRIS provides a list of diverse requirements for Medical Devices that must be completed to obtain a sanitary registration in Mexico. Nevertheless, it is often hard for foreign manufacturers to fully comply with all of them. Some of the most common cases are:
- Documentation not elaborated by the manufacturer
- COFEPRIS requirements are specific for Mexico and not necessarily for other countries
- Testing performed in representative samples
- Labels or certificates of analysis for representative models
- Subsidiaries and third-party manufacturers involved
- Documents issued for different manufacturers
- Products using other trademarks than those to be registered in Mexico
These and other cases can be solved by elaborating explanatory or clarification letters (statements). In this document, we list some examples of these type of letters that can be elaborated by the medical device manufacturer or, in some cases by the sanitary registration holder:
Explanatory letter related to commercial names (tradename or brand)
This type of letter is useful to explain how the device is named in the country of origin (or others) and how will be registered in Mexico. It is also worth to explain if there are any difference in the name of the device in technical and/or legal documents.
Explanatory letter for subsidiaries and third-party manufacturers
The aim of this writing is to explain the relationships between different companies involved in the manufacturing process of a medical device. It typically explains who the “real” manufacturing site, the legal manufacturer and/or third-party manufacturers are.
Explanatory letter for testing on representative samples
Testing performed on medical devices, including performance, shelf life, and biocompatibility tests, are typically performed on samples of a few models (codes), because it is faster and cheaper. However, if the product range of the same product has the same indication of use, materials and packaging, and the studies are aimed to be representative, this can be explained in a letter.
Explanatory letter for representative labeling and/or certificates of analysis
There are medical devices with models differing in size, color or other non-significative characteristics; though, they share documents such as labels and certificates for finished products. In those cases, instead of sending labels for each code, a representative label is sufficient, meanwhile it is accompanied by a letter explaining the representativity.
Documentation not elaborated by the manufacturer
This type of statement is helpful to explain documents elaborated by third party companies or laboratories. For example, biocompatibility, clinical or bench testing are generally performed by other organizations and it is not always easy to formally state the relationship with the manufacturer. Additionally, some companies do acquisitions of other firms or products already in the market and do not repeat all the documentation or testing.
Explanatory letter for equivalent documents
Some manufacturers elaborate certain documents in a different way as expected by COFEPRIS due to the nature of the device. In those cases, it is worth to explain the equivalency of a local requirement with the presented documents. Certificates for finished product, packaging, testing, manufacturing process are some examples.
Legal and technical documentation for medical devices is as different and complex as the wide variety of products in the market. When registering those products in Mexico, it is important to explain in detail to the authority how the documents fill each requirement to avoid preventions or delays in approvals. If you need support elaborating explanatory letters for your submissions, please contact us at email@example.com or check our guidelines or checklists.