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Adverse Event Reporting New Zealand

lizVR

Registered
#1
I am looking to find guidance for manufacturers outside of New Zealand on adverse event reporting. Specifically, I need a reference that confirms (or not) that when an adverse event occurs it does not need to be reported unless field corrective actions will be taking place. Similar information is provided in MEDDEV 2.12-1, Rev. 8 5.1, MPR Guidance 10/03/2011 2.3.2 and ARGMD v1.1 p301. I just can't confirm that for New Zealand's Medsafe Legislation or Regulation.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
I am looking to find guidance for manufacturers outside of New Zealand on adverse event reporting. Specifically, I need a reference that confirms (or not) that when an adverse event occurs it does not need to be reported unless field corrective actions will be taking place. Similar information is provided in MEDDEV 2.12-1, Rev. 8 5.1, MPR Guidance 10/03/2011 2.3.2 and ARGMD v1.1 p301. I just can't confirm that for New Zealand's Medsafe Legislation or Regulation.
(Emphasis added, see below)

Are you referring to an event that occurred in NZ, or to an event involving the same device model that occurred outside NZ?

This page seems to indicate the opposite of the condition (highighted in bold) above:
Non-reportable Events
The following events are not considered to be reportable events and need not be reported to Medsafe. Medsafe will not normally investigate such events.

  • Deficiency of a new device found by the user prior to its use. The deficiency being one that would always be detected by the user, where no injury has occurred, and it is not likely that a serious injury could occur due to the deficiency.
  • Adverse event caused by patient conditions, where the root cause of the event is due to a patient condition.
  • Service life or shelf life of the medical device. When the only cause for the adverse event was that the device exceeded its service life or shelf life as specified by the manufacturer and the failure mode is not unusual.
  • Malfunction protection operated correctly (i.e. fail-safe). Adverse events which did not lead to serious injury or death, because a design feature protected against a malfunction becoming a hazard.
  • Adverse events described in a recall, recall for product correction or hazard alert.
  • Issues arising due improper use or maintenance of the device, or due to damage to the device.
  • Expected and foreseeable events, which are fully described in the instructions for use.
 

lizVR

Registered
#3
My question is when an event occurs in US, for example, how do I justify not reporting in NZ. I'm looking for guidance to reference in our justification for the process.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
The Medicines Act 1981 says:
41 Duty of importer or manufacturer to report untoward effects of medicines
(1) If at any time the importer or manufacturer in New Zealand of any medicine has reason to believe that any substantial untoward effects have arisen from the use of the medicine whether in New Zealand or elsewhere, the importer or manufacturer shall forthwith notify the Director-General of the nature of those effects and the circumstances in which they have arisen, so far as they are known to him.
(2) Every person commits an offence against this Act and is liable on conviction to a fine not exceeding $1,000 who fails to comply with subsection (1).
(My emphasis)
I didn't find a similar clause for Medical Devices, or one that makes the above section applicable to Medical Devices, and ran out of time. However, I speculate that there is no reason why a similar policy won't apply.
 

lizVR

Registered
#5
I appreciate the reply, however, I'm still not sure of our requirements for this case. The event in question is reportable in the US for instance because it needed surgical intervention to prevent permanent impairment or damage, however, did not indicate a risk to public health or the need for market withdrawl. I believe that it is not reportable, in this case, similarly to the other geographies in which we market, but I don't have a reference to confirm that explicitly. Thank you for your help!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
I appreciate the reply, however, I'm still not sure of our requirements for this case. The event in question is reportable in the US for instance because it needed surgical intervention to prevent permanent impairment or damage, however, did not indicate a risk to public health or the need for market withdrawl. I believe that it is not reportable, in this case, similarly to the other geographies in which we market, but I don't have a reference to confirm that explicitly. Thank you for your help!
What is the NZ legislation basis of your belief that this is not reportable? Your description "it needed surgical intervention to prevent permanent impairment or damage" seems to meet the NZ definition of a Serious Injury.
 

lizVR

Registered
#7
Because it occurred in the US. For example, it is not reportable in the EU, Australia or Canada per the guidances I referenced earlier (MEDDEV 2.12-1, Rev. 8 5.1, MPR Guidance 10/03/2011 2.3.2 and ARGMD v1.1 p301). These state that we do not need to report the event that occurred outside of these geographies unless the event indicated a need for recall of the device. I just can't find that explicitly for NZ.
 
#10
I heard back from MEDSAFE on the issue and received the following communication in an email from a Product Safety Advisor

"Medsafe has a role to monitor the safety of medicines and medical devices in New Zealand. One way of achieving this is post-marketing surveillance via the monitoring of medical device incident reports in New Zealand.
  • If an event occurred outside of New Zealand (and did not involve a NZ manufactured product) then Medsafe does not routinely need to be advised.
  • In an event where the device may have contributed to or caused the death of a patient, and the product is available in New Zealand, then Medsafe would appreciate being informed as there may be public interest in the event.
  • If the event lead to a corrective action of the device eg a Safety Alert or Recall action then yes Medsafe does need to be advised"

I then asked for a further more specific reference to guidance documents or regulation and received this additional detail

"Currently there is no there is no guidance or part of the regulation that can be referenced (as there is no legislation to enforce this presently)

New legislation is in the process of being developed. The Therapeutics Products Bill will replace the Medicines Act (1981) and it is envisaged that mandatory reporting of adverse events will be a feature of this new legislation. Clarification regarding the capture of overseas reports should also be a feature."
 
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