(Mexican Official Standard NOM-220-SSA1-2002

Pharmacovigilance Installation and Operation, EXT 01761)

A. What to Report
A.1. Any adverse event that points to, or appears to have a causal relation to the
device or investigational procedure. (§2.1.22, §5)

B. AE Reporting time frames (§5.5.1)

B.1. Severe (serious) – Notification in writing (fax or electronic mail) as soon
as possible within seven (7) calendar days after sponsor’s first
notification, followed by as full a report as possible within the
next eight (8) calendar days.

B.2. Light, Moderate - Both expected and unexpected – report in the final
study summary that includes all research sites.

C. Intensity (Severity) of the Clinical Manifestation (§3.2)

C.1. Severe (serious) – Any morbid manifestation caused by administration of the
device and which
(A) Endangers the life of the patient or causes his or her death
(B) Requires hospitalization or a longer hospital stay
(C) Causes persistent or relevant incapacity
(D) Causes alterations or malformations to the newborn
(E) Lethal; contributes directly or indirectly to the patient’s death

C.2. Moderate Interfere with usual activities (might cause the patient to miss
work or school) without directly threatening the life of the
patient. These require treatment and may or may not require
suspension of device use.
C.3. Light Symptoms and signs present are easily tolerated, do not need
treatment, do not lengthen hospitalization time, and might
require (or not) the suspension of device use.
D. Information Quality (§2,1.3) – the degree of completeness and accuracy of data
included in the notification of suspicion of adverse events:
D.1. Grade 0 When the date of onset of an adverse event or its treatment
dates is or are unknown.
D.2. Grade 1 The dates of onset and treatment are specified from the
beginning.
D.3. Grade 2 In addition to the data of Grade 1, the device involved, its
indication, extent of use or application, and outcome are
reported.
D.4. Grade 3 In addition to the data of Grade 2, data related to the re-
appearance of clinical manifestation following re-administration
of the device (positive challenge) is included.

E. Categories of probability for the assessment of causality (§3.1)

E.1. Certain An event that occurs within a reasonable period of time after
administration of the device and which cannot be explained by
the natural evolution of the disease or condition, by a
concomitant pathology or by the administration of drugs or
other devices.
 E.2. Probable An event following a reasonable sequence of time after the last
administration of the device and that only with difficulty might
be attributed to the natural evolution of the disease or
condition, concomitant pathology, or to the administration of
other drugs or devices.
E.3. Possible An event followed by a reasonable time sequence after the last
administration of the device, which also can be attributed to the
natural evolution of the disease or condition, concomitant
pathologies, or to the administration of other drugs or devices.
E.4. Doubtful An event following a period of time from the last administration
of the procedure, rendering the causality improbable (but not
impossible), which could be explained in an acceptable manner
as part of the natural evolution of the disease or condition, or
else due to the presence of concomitant pathologies or to the
administration of other drugs or devices.
E.5. Conditional/Unclassified - An event that cannot be appropriately evaluated
due to the need for more data or because additional data is still
being analyzed.
E.6. Non-assessable/Unclassified – A report suggesting an adverse event that
cannot be evaluated due to the fact that the information
collected is insufficient or contradictory. The report cannot be
completed or verified.
F. How to Report
F.1. The obligation to report suspicions of adverse events during the execution of a
clinical study fall jointly on Gynesonics and the Research Center(s) carrying out
the study.
F.2. Must use “Official Notification Form of Suspicion of Adverse Reaction”.
F.3. Report to the National Pharmacovigilance Center, an entity within COFEPRIS.