Global Medical Device Regulatory Landscape

Reporting To Regulatory Authorities - 8.2.3

A look at the key regulatory bodies responsible for medical device standards and reporting across the globe. Click on any card to visit the agency's website.

Standard Operating Procedures and Regulations

Adverse Events (OP046) Recalls (OP016) HHE (OP058) IMDRF Codes FDA MDR Codes

MDR/Vigilance Report Timeline

Country	MDR/Vigilance Report	Complaint	Date Received	Awareness Date	Last Reportable Date	Filling Date	Preliminary Report	Final Report	Aging
USA	MDR-3005053560-2024-00001	WELLSTAR KENNESTONE HOSPITAL	4/9/2024	4/9/2024	5/9/2024	5/9/2024	N/A	N/A	0
USA	MDR-3005053560-2024-00002	Baylor Medical Center At Irving	5/6/2024	5/6/2024	6/6/2024	6/6/2024	N/A	N/A	0
USA	MDR-3005053560-2024-00003	RHODE ISLAND HOSPITAL	7/9/2024	7/9/2024	8/9/2024	8/8/2024	N/A	N/A	-1
USA	MDR-3005053560-2024-00004	UCH Longs Peak Hospital	8/26/2024	8/26/2024	9/26/2024	9/25/2024	N/A	N/A	-1
USA	MDR-3005053560-2024-00005	VA MEDICAL CENTER-BOISE	9/5/2024	9/5/2024	10/5/2024	10/4/2024	N/A	N/A	-1
USA	MDR-3005053560-2024-00006	University of Southern California	10/28/2024	10/28/2024	11/28/2024	11/26/2024	N/A	N/A	-2
USA	MedSun Report - 1600820000-2024-8034	Iowa Methodist Medical Center	11/4/2024	11/4/2024	N/A	N/A	N/A	N/A	0
USA	MDR-3005053560-2024-00007	Marshall Medical Center	12/11/2024	12/11/2024	1/11/2025	1/10/2025	N/A	N/A	-1
USA	MDR-3005053560-2024-00008	Palm Bay Hospital	12/26/2024	12/26/2024	1/26/2025	1/24/2025	N/A	N/A	-2
USA	MDR-3005053560-2025-00001	ST MICHAEL MEDICAL CENTER - SILVERDALE	1/16/2025	1/16/2025	2/16/2025	2/16/2025	N/A	N/A	0
USA	MDR-3005053560-2025-00002	Cabell Huntington Hospital	3/4/2025	3/4/2025	4/4/2025	3/25/2025	N/A	N/A	-10
USA	AI Request 3005053560-2025-00002	Cabell Huntington Hospital	4/15/2025	4/15/2025	5/29/2025	5/29/2025	N/A	N/A	0
USA	MDR-3005053560-2025-00003	Medical City Arlington	4/16/2025	4/16/2025	5/16/2025	5/15/2025	N/A	N/A	-1
USA	MDR-3005053560-2025-00004	Lucile Packard Children’s Hospital	4/29/2025	4/29/2025	5/29/2025	5/29/2025	N/A	N/A	0
USA	MDR-3005053560-2025-00005	City of Hope National Medical Center	5/23/2025	5/23/2025	6/23/2025	6/20/2025	N/A	N/A	-3
USA	MDR-3005053560-2025-00006	Children's National Medical Ctr.	6/5/2025	6/5/2025	7/5/2025	7/2/2025	N/A	N/A	-3
USA	MDR-3005053560-2025-00007	Louisianna Children’s Medical Center	7/11/2025	7/11/2025	8/11/2025	8/8/2025	N/A	N/A	-3
Canada	MDPR_Form_Comp-0000282_HC	C.H.S, LTD	8/8/2025	8/13/2025	8/23/2025	8/19/2025	x	x	-4
USA/CA	MDR-3005053560-2025-00009	C.H.S, LTD	8/8/2025	8/13/2025	9/13/2025	9/12/2025	N/A	N/A	-1
Canada	MDPR_Form_Comp-0000373_HC	C.H.S, LTD	9/4/2025	9/4/2025	9/14/2025	9/12/2025	x	x	-2
USA/CA	MDR-3005053560-2025-000010	C.H.S, LTD	9/4/2025	9/4/2025	10/4/2025	9/30/2025	N/A	N/A	-4
USA	MedWatch Report - MW5160112	University of Southern California	10/28/2025	10/28/2025	11/28/2024	11/26/2024	N/A	N/A	-2
USA	MedSun Report - 0700100000-2024-8059	Bridgeport Hospital	12/18/2024	12/18/2024	N/A	N/A	N/A	N/A	N/A

Updated Risk Profile: IMDRF and FDA MDR Codes

ID	Description	IMDRF (L1)	FDA MDR (L1)	Rationale for Final Code Selection
3860 Infusion Pump Risks
5	Battery internal component failure leads to over-heating and possible fire.	A07	1201	Device malfunction leading to an energy/power problem.
6	Use of pump in areas of explosive anesthetic usage.	D06	4309	D06 (Cause Traced to Environment) is best for use in an inappropriate environment, complementing the A16/4309 used later.
18	Equipment is operated when protective covers are removed or disassembled.	D05	29	D05 (Cause Traced to Servicing/Maintenance) addresses the non-use/non-operation factor of removal of essential parts, leading to device exposure.
19	Use of AC power extension cords increases leakage current risks.	A17	1201	A17 (Energy Problem) directly addresses the electrical risk created by the accessory/set-up.
55.3	DERS drug library card includes incorrect infusion parameters and/or limits.	A09	2001	A09 (Undelivered Therapy) focuses on the functional error due to incorrect device data.
69	Over- or under-infusion when previous patient settings are used with new patient.	A14	2901	A14 (Usage Problem) captures the setting/programming error (user oversight).
70	Observer tampering with Pumps causes over or under-infusion.	A14	2901	A14 (Usage Problem) is the best fit for intentional misuse/tampering leading to a delivery error.
71	Observer tampering with Pumps causes Pump to shut off.	A14	2901	A14 (Usage Problem) captures the intentional misuse/tampering resulting in unexpected device behavior.
77	Flow Rate accidentally set too high.	A14	2901	A14 (Usage Problem) captures the programming error.
86	Full or partially occluded Administration Set line affects accuracy.	A04	1301	A04 (Mechanical Problem) often includes occlusion issues caused by mechanical/physical factors.
89	Air bubbles > 200 uL in volume delivered.	A03	1103	A03 (Fluid/Gas/Supply Flow Problem) is the standard code for air-in-line.
97	Fluid free-flow causes over infusion.	A03	1103	A03 (Fluid/Gas/Supply Flow Problem) is the standard code for free flow.
98	Unobserved free-flow condition when Administration Set is used without drop chamber.	A14	2901	A14 (Usage Problem), as the root cause is the improper use of the set.
99	Pump door is not closed allowing inadvertent fluid free-flow.	A14	2901	A14 (Usage Problem) captures the operator failure to secure the door.
103	Injury caused by mechanical breakage with the patient attached assemblies.	A04	1301	A04 (Mechanical Problem) addresses component breakage.
104	Unintentional gravity free-flow administration of infusate.	A03	1103	A03 (Fluid/Gas/Supply Flow Problem) addresses the delivery failure mechanism.
107	Improperly loaded Administration Set allows inadvertent fluid free-flow.	A14	2901	A14 (Usage Problem), as the root cause is improper loading/set-up.
108	Faulty IV set does not allow the pump free flow prevention mechanism to close completely.	A04	1301	A04 (Mechanical Problem) addresses the physical failure of a component (the set).
122	Drug interactions with I.V. Sets causes patient hazards.	A06	1601	A06 (Material/Chemical Problem) addresses chemical incompatibility between drug and set material.
124	Sterile Package is damaged, allowing non-sterile product use.	A13	2701	A13 (Sterility/Packaging Problem) directly addresses packaging failure.
127	Administration Set biocompatibility failure.	A06	1601	A06 (Material/Chemical Problem) addresses device material failure (leaching/toxicity).
145	Improper assessment due to use of SpO2 oximeter as sole diagnostic indicator.	A14	2901	A14 (Usage Problem) captures the misuse of information/device outside IFU.
157	Unattainable or inaccurate SpO2 readings due to fingernail polish or artificial nails.	A01	4001	A01 (Patient Device Interaction Problem) addresses patient factors interfering with function.
177	Pump detaches from I.V. Pole due to improper installation by user.	A14	2901	A14 (Usage Problem) for improper installation.
178	Wrong I.V. Pole used (magnetic).	A14	2901	A14 (Usage Problem) for incorrect equipment use/misuse.
183	IV pole can tip over or break when operator improperly assembles IV pole.	A14	2901	A14 (Usage Problem) for improper assembly/setup.
229	Audible alarm level is too quiet for MRI use.	A07	1201	Device malfunction leading to an energy/power problem.
230	Audible alarm level is set too low for MRI use.	A07	1201	A07 (Alert/Alarm Problem) addresses the functional setting error (even if user-set, it's a device alert parameter issue).
232	Loud noise during MRI scan obscures audible alarm of pump.	A16	4309	A16 (External Environmental Factor Problem) addresses the interference of the environment (MRI noise) with the device function (alarm audibility).
244	User mis-programs Pump due to hard to understand controls.	A14	2901	A14 (Usage Problem) captures the user programming error.
257	Pump operated in wrong mode during infusion results in inaccurate fluid delivery.	A14	2901	A14 (Usage Problem) captures the operator selecting the wrong mode.
257.5	Pump operated with improper selection of dose vs. concentration units.	A14	2901	A14 (Usage Problem) captures the unit selection error.
270	User enters incorrect but valid value(s).	A14	2901	A14 (Usage Problem) captures the data entry error.
274	User routes infusion line(s) in a manner which could lead to strangulation.	A14	2901	A14 (Usage Problem) captures the misuse related to line routing.
275	User thinks they are programming rate of drug in Channel A line, but is in fact programming rate for drug in Channel B.	A14	2901	A14 (Usage Problem) captures the channel confusion error.
276	During multiple line infusion, user mixes-up IV drugs and places IV sets into wrong infusion channel.	A14	2901	A14 (Usage Problem) captures the input set-up error.
277	User mixes up infusion lines during infusion and connects to the wrong port at the patient administration site.	A14	2901	A14 (Usage Problem) captures the administration set connection error.
3880 Patient Monitor Risks
10	Use of monitor in areas of explosive anesthetic usage.	D06	4309	D06 (Cause Traced to Environment) best addresses use in an inappropriate environment.
81	Dysfunctional hemoglobins found in patient's blood can lead to inaccurate SpO2 readings.	A01	4001	A01 (Patient Device Interaction Problem) addresses patient physiology interfering with device function.
160.12	Intra-aortic balloon pump (IABP) use distorts BP waveform, and can lead to unexpected pressure readings.	A01	4001	A01 (Patient Device Interaction Problem) addresses interference from another device within the patient.
164	Power Supply is placed too close to the MRI.	D06	4309	D06 (Cause Traced to Environment) addresses the improper environmental setup/placement.
173	Inappropriate disposal of batteries leads to fire or explosion.	D05	29	D05 (Cause Traced to Servicing/Maintenance) addresses end-of-life handling/disposal error.
178	Monitor is mounted to Non-MRI compatible equipment and brought into zone IV causing a projectile.	A05	1401	A05 (Device Physical Problem) addresses the projectile (unintended movement/mechanical hazard).
205	While monitoring... user fails to detect or understand critical notifications and warnings... patient suffers a critical event that goes undetected.	A14	2901	A14 (Usage Problem) addresses failure to interpret and react to device output.
213	Improper accessories used with the device which can lead to MRI incompatibility.	A14	2901	A14 (Usage Problem) addresses improper equipment selection/set-up.
220	User brings inappropriate tools into MRI magnet area to assemble or repair monitor.	A14	2901	A14 (Usage Problem) addresses egregious misuse/violation of safety rules.
222	Injury caused when NIBP cuff is attached to a limb receiving IV or fluid therapy.	A14	2901	A14 (Usage Problem) addresses incorrect clinical procedure/set-up.
228	A user enters the "STANDBY All Alarms OFF" during patient setup. An alarm condition occurs, but goes unnoticed.	A14	2901	A14 (Usage Problem) addresses deliberate user disabling of a key safety function.
229	The alarm volume is set to 0% by user to silence all audible alarms. An alarm condition occurs, but goes unnoticed.	A14	2901	A14 (Usage Problem) addresses deliberate user disabling of a key safety function.
236	After monitoring a patient with an infection, an operator disconnects a single-use accessory and reuses it on the next patient.	A14	2901	A14 (Usage Problem) addresses failure to follow IFU regarding single-use accessories/sterility.
238	A user with multiple systems assigns the remote tablet's and base's radio channel to an unintended monitor.	A14	2901	A14 (Usage Problem) addresses setup/programming error leading to data confusion.
33	Failure to monitor when the Remote Monitor does not show the full parameter choices from the patient monitor.	A09	2001	A09 (Undelivered Therapy) addresses the failure to display correct monitoring data.
60	Lack of monitoring when patient ECG, SpO2, IBP POD or Agents module does not communicate with monitor.	A07	1201	A07 (Alert/Alarm Problem) addresses the loss of monitoring/communication leading to a failure to alert.

US

Food and Drug Administration (FDA)

Canada

Health Canada

United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA)

European Union (EU)

European Commission - Public Health

Brazil

Brazilian Health Regulatory Agency (ANVISA)

Japan

Pharmaceuticals and Medical Devices Agency (PMDA)

Asia-Pacific

Asian Harmonization Working Party (AHWP)

Australia

Therapeutic Goods Administration (TGA)

South Korea

Ministry of Food and Drug Safety (MFDS)

Global Event Reporting Timeline

As a general principle, there should be a predisposition to report rather than to not report in case of doubt on the reportability of an incident. The decision about requirement to report an event should be considered across all markets where the product is marketed to ensure any foreign event reporting requirements are met.

Governing regulation:

21 CFR Part 803

Regulatory agency / authority:

Food and Drug Administration (FDA)

Initial notification:

Within 5 working days of becoming aware of events that require remedial action to prevent an unreasonable risk of substantial harm.
Within 30 calendar days of becoming aware of deaths, serious injuries, malfunctions.

Governing regulation:

EU Regulation 2017/745 (Article 87)

Regulatory agency / authority:

Competent Authority of the Member State in which the incident occurred

Initial notification:

Immediately, and not later than 2 days after awareness for a serious public health threat.
Immediately, and not later than 10 days after awareness for a death or an unanticipated serious deterioration in health.
Immediately, and not later than 15 days after awareness for any other serious incident.

Governing regulation:

SOR 98/282 Device Regulation (Points 59 and 60)

Regulatory agency / authority:

Health Canada

Initial notification:

Submit report as soon as possible, within 10 calendar days if death or serious deterioration in health has occurred.
Submit report as soon as possible, within 30 calendar days if death or serious deterioration in health did not occur but might if the incident were to recur.

Governing regulation:

UK Medical Devices Regulations 2002 (as amended)

Regulatory agency / authority:

Medicines and Healthcare products Regulatory Agency (MHRA)

Initial notification:

Within 2 days of awareness for a serious threat to public health.
Within 15 days of awareness for all other reportable incidents.
Within 10 days of awareness for a death or serious deterioration in health.

Governing regulation:

Medical Devices Ordinance (MedDO)

Regulatory agency / authority:

Swissmedic

Initial notification:

Reporting timelines are aligned with the EU MDR, requiring swift notification based on the severity of the incident.

Governing regulation:

Pharmaceuticals and Medical Devices Act (PMD Act)

Regulatory agency / authority:

Ministry of Health, Labour and Welfare / PMDA

Initial notification:

Within 15 days of awareness, report any deaths.
Within 15 days of awareness, report malfunctions/faults that could lead to serious events with an increasing trend.
Within 30 days of awareness, report unanticipated serious events.
Within 30 days of awareness, report anticipated serious events with a flat trend.

Governing regulation:

Therapeutic Goods Act 1989; Therapeutic Goods (Medical Devices) Regulations 2010

Regulatory agency / authority:

Therapeutic Goods Administration (TGA)

Initial notification:

Within 48 hours if it represents a serious threat to public health.
Within 10 days if it led to the death or a serious deterioration in the state of health.
Within 30 days if a recurrence might lead to death or a serious deterioration in the state of health.

Governing regulation:

Medical Device Act

Regulatory agency / authority:

Ministry of Food and Drug Safety (MFDS)

Initial notification:

Within 7 days for side effects resulting in death or threat to life.
Within 15 days for reversible/temporary side effects or other safety/efficacy concerns.
Within 30 days for any other reportable adverse event.

Governing regulation:

Resolution RDC No. 67/2009, and Resolution RDC No. 23/2012

Regulatory agency / authority:

Agência Nacional de Vigilância Sanitária (ANVISA)

Initial notification:

Within 72 hours, report death, serious threat to public health, or falsification occurring in Brazil.
Within 10 days, report severe adverse event, without associated death.
Within 30 days, report events with potential for severe adverse events under specific conditions.

Adverse Event Databases

Publicly accessible databases for searching adverse event reports and other regulatory information.

Reporting To Regulatory Authorities - 8.2.3

Standard Operating Procedures and Regulations

MDR/Vigilance Report Timeline

Updated Risk Profile: IMDRF and FDA MDR Codes

US

Canada

United Kingdom

European Union (EU)

Brazil

Japan

Asia-Pacific

Australia

South Korea

Global Event Reporting Timeline

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Governing regulation:

Regulatory agency / authority:

Initial notification:

Adverse Event Databases

United States

European Union

Canada

United Kingdom

Emergency Care Research Institute

Literature Review

Distributor Agreements

EU Distributor Agreements

Canada Distributor Agreement

UK Distributor Agreement

Japan Distributor Agreement

Australia Distributor Agreement