Malaysia Medical device regulations June 2016

LFZR88

Involved In Discussions
#1
Hi All,
does anyone know if Malaysia are still heading to the hard stop of having to have device registrations in place by June 2016, they were extended by a year in 2015, but I have seen nothing on the MoH website to say that it will actually be enforced, can anyone shed any light on this??
Many thanks
:thanks:
 
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B

Bigdubz61

#3
Hi LFZR

I am currently registering 2 devices in Malaysia. It is very arduous as you need to supply everything in their format with respect to their Template, otherwise the submission is rejected.

It is more than a few hours work, depending on the device, of course, but certainly not an easy registration.

Good luck with yours.
 

Murni Ahmad

Involved In Discussions
#4
Hi,

I hope this help.

As long as you submitted registration application by 30th June 2016, under pending CAB verification or MDA evaluation, you can still import and supply the products with the payment advice or acknowledgement receipt generated from the [email protected] at least until 2020*

As for new product submitted 1st july and onwards, by right you need to get it registered first before supply. But you can write in to MDA to seek approval to supply, if its a critical medical devices, they might let you in.

*t&c applied

Regards,
Murni
 
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