Language requirements in Malaysia - What language the IFUs need to be in

Hi folks!

I have been asked to find out what language the IFUs need to be in for certain countries. I have managed to find answers to all of the list except Malaysia. Their Department of Health website is not very clear and I just can't seem to find the answer I am looking for. So, does anyone on here know what language the IFUs shoule be in for the Malaysian market for a device that is only used by professional users (not sold to the general public).

Thanks

Bump - Is anyone here familir with medical device language requirements in Malaysia? MY appreciation in advance!

Their Department of Health website is not very clear and I just can't seem to find the answer I am looking for.

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You are right. I can't seem to find the answer also. Perhaps those experienced users of this website from Malaysia can throw some light.

Generally, you can't be wrong by having dual (English + Malay) language. I had seen it on some machines.

Thanks for that Harry, but I was hoping to avoid the Malay version if possible. Obviously if it is a requirement then we will have to go with it, but if not....

I'm surprised that nobody so far has known the answer to this as we seem to have a fair few contributors from Malaysia on here.

Thanks in advance for a definitive answer, and by the way, what a fantastic resource this site is. I wonder if it would be worth having a sub-board for this type of query as it isn't strictly 13485 related, but with the wealth of knowledge subscribing to these boards you kinda know an answer to almost ANY query regarding medical devices and different markets will be forthcoming. Anyway, just a thought.

Cheers all.

Malaysian

according to:

US Commercial Service – Kuala Lumpur
Contact: Natila Ahmad
Phone: +60-3-2168-5101
Fax: +60-3-2142-1866
Email: [email protected]
Address: American Embassy
US Commercial Service
376 Jalan Tun Razak 50400
Kuala Lumpur

Could you please kindly consider to give me a copy of your frech list?

zhang126 said:

Malaysian

according to:...............................

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The Malaysian Language is 'Bahasa Malaysia' which is the 'Malay' Language.

Hi All,

It is stated in the Malaysia's "Medical Device Regulation 2012" P.U. [A] 500 page 240
For home use device, required language is Bahasa Malaysia.
For other type of medical device will be under the authority consideration.

Hope this help.