Notification and submission requirements for medical device material changes

L

Liz G

#1
I am in the process of assessing the impact of a material change on the regulatory status of products which are sold into a number of international markets. The material change would be to a single component which is included in a kit; there are no changes to the other components in the kit.

Specifically I would like to know:
1) whether or not a material changes require notification / re-registration and, if so,
2) what is the cost of the notification / re-registration, if any, and
3) what is the expected approval time for the notification / re-registration, if any, or may the modified product be imported immediately upon notification?
As a side note, the component in question is considered to be non-patient-contacting, so there are no additional biocompatibility concerns associated with the change.

Countries which I am struggling to find change control information on are:
  • Ecuador
  • Guatemala
  • Honduras
  • Macedonia
  • Montenegro
  • Nicaragua
  • Panama
  • Serbia
  • Ukraine
  • Uruguay
  • Venezuela
If anyone has any information on any of these markets, it would be greatly appreciated!

:thanks:
 
Elsmar Forum Sponsor
L

Liz G

#2
Further to this - is there a difference in the change requirements if the change is:
  • A change in the material type, e.g. polypropylene to polyethylene; versus
  • A change in the material specifications, with no change to the material type, e.g. polypropylene 1 to polypropylene 2.
I would like to clarify this as I know that the level of detail for materials varies between different countries/registration processes, where some countries request detailed information, whereas others request only top level material information.

:thanks:
 

pkost

Trusted Information Resource
#3
You are asking for a lot of specific detail in a lot of different markets with only general information. It is not possible to give you an accurate answer and if you don't have the in house expertise it may be advisable to take on a consultant to assist

A general answer would be you need to review the regulation in each market for change control where there is some flexability use a risk assessment to justify whatever decision you make
 
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