EMERGO SUMMARY OF KEY POINTS:

• Mexican regulators have proposed changes to classification, grouping and other processes for medical devices requiring COFEPRIS registration.
• Changes would take effect in January 2018 at the earliest.
• All changes must be published in Mexico’s Official Diary before full implementation.

Mexican regulators are in the early stages of revising various elements of the country’s sanitary registration process for medical devices, including classification, biocompatibility and technovigilance.

According to Emergo consultants in Mexico City, the Mexican Farmacopea has published draft changes to the COFEPRIS registration process for devices, but those changes will not become official until their publication in the Mexican Official Diary. The earliest possible official publication of these changes is expected to be January 2018.

Classification and grouping
Proposed classification changes (link in Spanish) include listing device types as subsets rather than in paragraph form, as well as extending the intended use section and adding eight new device categories. Furthermore, classification criteria have been clarified, while classification requirements for diagnostic agents have been expanded into three rules.

Under grouping changes (link in Spanish), devices intended for use as external controls would be grouped according to specialty.

These reworkings of COFEPRIS classification rules are the most significant of the proposed changes included in the Farmacopea. The rules may not change how COFEPRIS classifies devices, but could affect which criteria are used to determine classification of a medical device or IVD.

Biocompatibility tests
A proposed new annex identifies tests and processes to evaluate device biocompatibility (link in Spanish); the annex is based on the ISO 10993-1 standard for biological evaluation of devices.

Sanitary registrations
Although no major changes to the Mexican registration process (link in Spanish) have been proposed, many of the existing explanatory sections of these regulations would be shortened; the definition of a medical device would however be broadened, and new sections would be added pertaining to intended use considerations.

Technovigilance
Regulators have proposed a new annex to technovigilance rules in order to standardize this process by defining technovigilance duties, necessary requirements to perform technovigilance and guidelines for related notifications as well as correctice and preventative actions.

More information on Mexico’s medical device regulatory system can be found in our COFEPRIS registration whitepaper, regulatory process chart and video overview.