Medical Device Importation into ASIAN Countries

[LQ. Fanny Lozano]

Hello everyone!!

I just wondered if someone could share their experience with submit for an importation permit in any of the ASEAN countries (Singapore, Malaysia or Thailand preferably). Because this will be the FIRST time we try to register our medical devices there and I feel that the information provided on their respective web pages and links isn't clear enough to undestand the whole protocol.

Thanks a lot for your information, I'd be very grateful to you!!

[Marc]

A quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!

Also see: Medical Device Registration Requirements in ASIAN Countries

[Ronen E]

In Reply to Parent Post by Marc

A quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!

Also see: Medical Device Registration Requirements in ASIAN Countries

I tried my best on that other thread you linked to.

Have a good weekend,
Ronen.

[JohnJohnson]

In Reply to Parent Post by LQ. Fanny Lozano

Hello everyone!!

I just wondered if someone could share their experience with submit for an importation permit in any of the ASEAN countries (Singapore, Malaysia or Thailand preferably). Because this will be the FIRST time we try to register our medical devices there and I feel that the information provided on their respective web pages and links isn't clear enough to undestand the whole protocol.

Thanks a lot for your information, I'd be very grateful to you!!

"Prior to Singapore’s Health Products Act 2007, most medical devices did not fall under governmental regulations. From August 1, 2010 onwards, all of these medical devices are required to be re-registered under the Health Products Act 2007 guidelines using the online Medical Device Information and Communication System (MEDICS) interface. Medical device firms will need to follow these new Singapore regulations to be successful there. Regulations in Singapore are typically strictly enforced."