Material & Related Labeling Changes - Which countries need to know?

funkgirl

Involved In Discussions
#1
Trying to find a comprehensive list of regulated countries who would require notification/registration/etc. for a material change to remove DEHP and subsequent labeling update to indicate presence/lack of DEHP for non-implantable patient contact devices (external only). Anyone have a ready list I could use as a baseline? Thanks!
 
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sreenu927

Quite Involved in Discussions
#3
It depends on your product classification and where your product has been registered.
However, not all countries have clear guidelines on the change notification. You can look in to the following:
1. FDA Guidance on Deciding when to submit a new 510(k) for a change to an existing device
2. NB MED 2.5.2/Rec 2 Reporting of Design changes and changes of the quality system for EU
3. Health Canada's Guidance Document for the Interpretation of Significant Change
4. Singapore: GN 21 Change Notification guidance

Hope this helps!

Regards,
Sreenu
 
L

Liz G

#4
I am looking for the same type of information - requirements for product changes in international markets - in this case specific to the French DEHP law (i.e. material additive change). In addition, there may be an associated labeling change as the "DEHP" symbol may appear on labeling as per BS EN 15986 Symbol for use in the labelling of medical devices - Requirements for labellingof medical devices containing phthalates.

If known, I am also interested in 1) the cost associated with the change notification, if any and 2) the approval time, if any. I am particularly interested in the requirements for the L. American countries if anyone specializes in that region!

Thank you Sreenu for the information in your previous post!



Some more information that I have obtained in relation to this topic...
  • Albania, Bangladesh, Iraq, Libya, Qatar, Trinidad & Tobago : no mandatory medical device registrations, therefore change notification is N/A.
  • Indonesia: Regulation of the Minister of Health of the Republic of Indonesia number 1190/MENKES/PER/VIII/2010 regarding medical devices and household products
    Sixth Part – Amendment of Marketing License – Article 24
    (1) The company should submit the amendment of the marketing license of Medical Devices and/or PKRT on the change of:
    a. size;
    b. packaging;
    c. labelling;
    d. Taxpayer Reference Number/NPWP.
  • Kosovo:
    Law No. 2003/26 22.6 states:
    Manufacturers or their authorized supplier must report to teh KMA and designated conformity assessment body on all changes relating to a medical device. (I cannot post a link to the website because I do not have enough posts, but there is a PDF link at kuvendikosoves org - you should be able to find it through Google.)
  • Singapore:Changes to Class A and B products require notification (no approval time, no cost) and changes to Class C products (for material changes and labelling changes) require technical notification ($1700, 75 working days). Refer to GN-21.
 
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