Changes to Good Manufacturing Practice Regulations in Mexico: SaMD, UDI and More

By Pedro Omar Sánchez Neri

Our second post on the new draft of the NOM for Medical Device Good Manufacturing Practices (GMP), PROY-NOM-241-SSA1-2024, discusses relevant updates concerning the restructure of content and key changes over the requirements for manufacturers, conditioners, and distributors of medical devices in Mexico.

Reorganization of PROY-NOM-241-SSA1-2024

This new draft contains several structural changes that simplify the organization.

Section 5, which described medical device classification, has been deleted. The Mexican Pharmacopoeia is the primary regulatory instrument for medical device classification.

The current version of the standard includes several paragraphs outlining the supporting features that a quality management system (QMS) should have under section 6.1.4. The draft simplifies this by turning section 5.1.4 into a list of five QMS continuous improvement activities that the organization’s upper management should oversee.

PROY-NOM-241-SSA1-2024 Consolidates Information About Retention Samples

NOM-241-SSA1-2021 introduced the concept of retention samples, which are defined as a certain quantity of raw materials or finished product to perform two complete analyses (except for sterility testing). Requirements and treatment of retention samples are outlined in several sections in the current standard, but the draft now collects most of it under section 11.4.  This specifies that these are applicable to formulated medical devices, IVDs, combined and biologically produced medical devices. Nonetheless, the ultimate intent and purpose of these and the requirement to keep samples per each manufactured lot remains unclear.

PROY-NOM-241-SSA1-2024 and Software as a Medical Device

Data on good manufacturing practices specific to software as a medical device (SaMD) s now under section 11.16 without significant changes. The only addition consists of a preface paragraph specifying that manufacturing activities must be performed according to the current Medical Device Supplement of the Mexican Pharmacopoeia.

PROY-NOM-241-SSA1-2024 and Important Absences

The draft removes two key aspects that we believe are in one case paramount to determine the proper scope and applicability of the good manufacturing and good storage and distribution practices; while the second affects Mexico’s progress with current global developments in medical device traceability.

Despite being mentioned many times throughout the text, the definition of registration holder is missing. Diverse manufacturing and quality obligations are assigned to the registration holder entity, namely under the contract manufacturing section (16.6 Maquilas), and under chapter 18 for Good Storage and Distribution Practices, where it states that registration holders must be informed of all complaints related to the quality of the device. Both activities are commonly considered the manufacturer’s responsibility. It is then important to consider further the role and features of registration holders.

The second item to highlight is the removal of the concept of UDI. Although UDI was not mentioned in the latest draft for Labeling of Medical Devices, it appears to be deliberately removed from the current version of the NOM-241, which is a strong indicator that no plans are in place from the regulator to adapt the UDI system in Mexico in the foreseeable future.

Concluding remarks

The new draft does not contain major content changes compared to the 2021 version and focuses instead on aligning its content and definitions with upcoming updates over other reference regulations for medical devices (PROY-NOM-137-SSA1-2024 and PROY-NOM-240-SSA1-2024). Nonetheless, a few minor changes are certainly worth discussing during the current consultation period, which lasts 60 days after the original publication of the draft (July 26).

Emergo by UL participates in this important exercise contributing to clear and transparent regulation for medical device manufacturers and supply chain stakeholders in Mexico.