Regulatory Open Forum

Greetings,

I'm wondering if any of you would be willing to share your labeling best practices especially with the numerous changes that are currently affecting the medical device industry (i.e. MDR, UKCA, etc.).

Additionally, I'd like to understand how some of you manage labeling for those countries, such as India and now Malaysia, that require the manufacturing registration number, import license number, or medical device license number on the product and/or packaging label. Do you have designated product/labels for only those countries? Do you place a separate label for only those products bound for that country? Do you require the distributor to place those labels?

Best, Tonia


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Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
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Hello,

I can say that in Russia & some CIS countries similar local labelling is also required (import license number etc).
Mostly this information is applied locally (additional label) at  local warehousing facilities

Oksana

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Oksana Kolosova
Moscow
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Original Message:
Sent: 22-Aug-2022 14:22
From: Tonia E. Bryant
Subject: Label Mgmt. - Individual Country Registrations

Greetings,

I'm wondering if any of you would be willing to share your labeling best practices especially with the numerous changes that are currently affecting the medical device industry (i.e. MDR, UKCA, etc.).

Additionally, I'd like to understand how some of you manage labeling for those countries, such as India and now Malaysia, that require the manufacturing registration number, import license number, or medical device license number on the product and/or packaging label. Do you have designated product/labels for only those countries? Do you place a separate label for only those products bound for that country? Do you require the distributor to place those labels?

Best, Tonia


------------------------------
Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
------------------------------

There are about 20 countries that require country specific labeling. It can be pasted in Manufacturing location or at  local warehousing facilities based on company procedure.

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Suresh Kumar Alagarsamy
Bangalore
India
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Original Message:
Sent: 22-Aug-2022 14:22
From: Tonia E. Bryant
Subject: Label Mgmt. - Individual Country Registrations

Greetings,

I'm wondering if any of you would be willing to share your labeling best practices especially with the numerous changes that are currently affecting the medical device industry (i.e. MDR, UKCA, etc.).

Additionally, I'd like to understand how some of you manage labeling for those countries, such as India and now Malaysia, that require the manufacturing registration number, import license number, or medical device license number on the product and/or packaging label. Do you have designated product/labels for only those countries? Do you place a separate label for only those products bound for that country? Do you require the distributor to place those labels?

Best, Tonia


------------------------------
Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
------------------------------