Malaysia - Full Labelling Local Language Translation

jon.loo

Starting to get Involved
#1
At the recent seminar held by Malaysia's regulatory authority, Medical Device Authority (MDA), it was clarified on the following requirement published in their labelling guidance:

4 Requirements for labelling
4.7 Language:
a) The use of Bahasa Malaysia and English shall be required for home use medical devices.

It was clarified that for home use products, all information must be provided in both Bahasa Malaysia AND English at all levels of packaging, including labels and IFUs. Furthermore, if the information is provided in English on the packaging, Bahasa Malaysia shall be required on the same level of packaging. To translate the information into Bahasa and provide as a insert is not acceptable.

The good thing is the authority is willing to listen to counter-proposals. I am just wondering if any of you have encountered such a requirement in any other country and If you have anything to say about such a requirement?
 
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EthanLoh

Involved In Discussions
#2
What does your CAB said? From my experience with Malaysia MDA, they may waive off certain requirements when come to implementation.

For other countries, (such as Thailand, China), the IFU, label and labelling must be in local language.
 
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