The Mexican Pharmacopoeia (FEUM) is an independent organization dedicated to advice the Mexican Ministry of Health. It is also in charge to elaborate quality/reference standards and technical documents for the regulation of medicines, medical devices, and other products. Among these documents, the Supplement of Medical Devices is a useful resource for manufacturers and distributors in Mexico. In this article, we describe the main features of it.
Supplement of Medical Devices
The supplement is considered an official document, which establishes the medical devices specifications to be accomplished to assure their quality, safety and performance. It is also a guideline of the analytical methods to be performed during the validation process. An interesting fact is that Mexico is the only country where its National Pharmacopeia released a document related to Medical Devices since 2006 (when the first edition was published). It is worth mentioning that this document is aligned with the harmonized regulatory system WHO model.
The latest edition is presented in the form of a physical book, with updates either in printed or digital version. On the other hand, as a requirement of the Mexican Standard NOM-241, all medical device manufacturers, distributors or sanitary registration holders in Mexico must possess an original copy of the latest version of this document, which is copyrighted.
Given the large amount of information that can be found in the Supplement, this document is organized in the following sections:
- General terms: it basically sets the rules on how the Supplement can be used
- 333 Solutions and reagents index: which enlists and describes some of the most common chemical solutions used either to test or manufacture medical devices.
- 65 Methods of analysis: describing in detail the test methods employed to ascertain the safety and quality of a determined medical device.
- 224 Monographs: related to frequently used medical devices.
- 10 Appendixes: including relevant rules and guidelines related to medical devices in Mexico. For instance: overview of regulatory framework, grouping and classification criteria, registration requirements and risks management.
As mentioned above, there are 224 monographs for the most common medical devices. However, this represents a very small set of products available in the market. Based on the World Health Organization, there are +2Million of different type of medical devices, categorized in approximately 22,000 groups. Therefore, the supplement still has a wide margin to include monographs in the future.
It is worth mentioning that if your medical device is included in this Supplement, then your product must meet the specifications and methods of analysis described in this document -in addition to the international standards.
The Supplement of Medical Devices is constantly under review due to scientific and technological advances. Therefore, the FEUM usually releases at least two updates between editions of the Supplement. For the current version, there are two updates (2019 and 2020).
A new update of the Supplement is coming in the following years, and it is expected to have important updates aligned to regulatory changes in Mexico and the rest of the world. If you have additional questions regarding this document and its implementation, please contact us at firstname.lastname@example.org