Hi Michelle
Submissions in Malaysia are acceptable in English, but if your device would be patient/at home, you might consider submitting a Bahasa version IFU/ label in addition to English or at least referencing you know patient facing labeling has to be in Bahasa.
If you have any already prepared, note that all advertising has to be pre-approved by MDA starting July 1, 2021 (backed off this requirement a year from this past July ). Advertising, etc. Is supposed to show your license # .
Not sure of Thailand or Indonesia. Anyone else comment- I thought they accepted submissions in English but let's see if anyone confirms?
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 09-Sep-2020 00:02
From: Michelle Knight
Subject: Is translation required for the ASEAN Common Submission Dossier
Hello,
I am preparing an ASEAN Common Submission Dossier for registration and was wondering if the entire dossier had to be translated from English for submission to:
- Malaysia (Bahasa Malaysia)
- Thailand (Thai)
- Indonesia (Bahasa Indonesia)
or whether it was only the labelling that required translation.
Looking forward to your feedback.
Michelle
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Michelle Knight
Clinical and Regulatory Manager
Coburg VIC
Australia
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