Mexico COFEPRIS Revises Draft of GMP Standard

By Pedro Omar Sánchez Neri

Background on NOM-241-SSA1-2024

Continuing our reports of the recent updates on Mexican Standards, the regulator in Mexico, COFEPRIS, published on July 26,  2024 a new draft  for Good Manufacturing Practices for Medical Devices.

In this first update, we review the revised definitions and concepts, followed by additional discussions on the rearrangement of activities introduced in the 2021 version of the standard, such as Sample Retention.

Significant updates in PROY-NOM-241-SSA1-2024

PROY-NOM-241-SSA1-2024 includes a few revisions, removing portions from the current 2021 version of the standard, aligning its scope to regulate products meant to be commercialized only within Mexico, which is consistent with the suggested acceptance of ISO 13485 under MDSAP as a prevailing standard for contract manufacturers in Mexico selling outside of Mexico.

General updates in PROY-NOM-241-SSA1-2024

References now include both Suplementos from the Mexican Pharmacopoeia (5.0 edition for medical devices and Sixth Edition for Establishments dedicated to the sale and distribution of health supplies), aligning all the existing medical device regulation.

The wording was revised on a few concepts, including Good Manufacturing Practices, Good Storage and Distribution Practices, Change Control, and Certificates of Analysis, without them representing a significant change in meaning. The definition of medical device was also updated  with the latest NOM drafts (PROY-NOM-137-SSA1-2024 and PROY-NOM-240-SSA1-2024), and the Stability definition was expanded to be applicable to IVDs, reconstituted lyophilized materials, working solutions, and materials extracted from sealed containers (when prepared, used, and stored in accordance with the manufacturer's instructions for use). In addition, a few new concepts were added.

New Definitions in PROY-NOM-241-SSA1-2024

The new definitions which have been added: counter label, counter labeling, medical device performance, labeling, electronic labeling, performance evaluation, date of manufacture or performance, and risk.

Counter label: The additional label containing the complementary health information, when the origin label does not partially or fully comply with the provisions of the regulatory reference indicated in NOM-137-SSA1-2008 (this also aligns with the recent draft PROY-NOM-137-2024-SSA1 for Medical Device Labeling)

Counter labeling: The activity of placing counter-labels on the finished imported medical device.

Medical Device Performance: The capacity of a medical device to achieve its intended use as stated by the manufacturer. Performance may include both clinical and technical aspects.

Labeling: The set of elements that include the label, counter label, user manual, instructions for use and any other information provided by the manufacturer or the registration holder that relates to the identification, technical description, indication for use and correct use of the medical device, excluding shipping documents.

Electronic labeling: Any form of labeling content provided on an accessible electronic medium by the manufacturer in connection with a medical device.

Performance evaluation: The assessment and analysis of data to establish or verify the in vitro diagnostic capability of a medical device to achieve its intended use.

Date of manufacture or production: The date on which the medical device was manufactured or produced.

Risk: The combined probability of occurrence of damage and its severity.

Revised Definitions in PROY-NOM-241-SSA1-2024

Two concepts were significantly reworded, altering the original meaning.

Complaint: The written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, feasibility, safety or performance of a medical device that has been released from the control of the organization or is related to a service that affects the performance of said medical device.

Electronic record: The set of information that includes electronic data (any combination of text, graphics, data, audio, images or other representation of information in digital form) that is created, modified, maintained, archived, restored or transmitted through a computerized system.

Revision Related to SaMD in PROY-NOM-241-SSA1-2024

A final note was added to further elaborate on the definition of SaMD.

SAMD: The software used for medical purposes, which has as its main characteristic that it does not require being part of the medical device hardware to fulfill the intended medical purpose; it is capable of running on general computing platforms and can be used alone or in combination with other products (such as a module, other medical devices, etc.). Mobile applications that meet this definition are considered software as a medical device. Software that operates the physical medical device is excluded from this definition.

NOTE: SaMD may also provide means and suggestions to mitigate a disease; provide information to determine compatibility, detection, diagnosis, monitoring or treatment of physiological conditions, health states, diseases or congenital deformities; be an aid in diagnosis, detection, monitoring, determination of predisposition; prognosis, prediction, determination of physiological state.

This added note draws elements from Appendix X of the 5.0 Edition of the Medical Device Supplement of the Mexican Pharmacopoeia, and aligns with the SaMD definition included in the aforementioned drafts.

Concluding remarks

This recent update reflects an effort from the Ministry of Health to align technology and commercial developments (this revision takes place two years after the latest update came into effect, while the previous remain unchanged for nine years) with regulatory progress.

Emergo by UL hopes this trend will continue, keeping a more agile and suitable regulatory environment for manufacturers worldwide.