Distributor for Products used in Medical Laboratories - Is ISO 13485 Required?

S

siewkingbee

#11
I do see we will be more applicable for GDPMDS.
In Malaysia there is no one to certify for GDPMDS.
Anywhere stated specifically that it is for medical manufacturers?
Just wanna double confirm, thanks for the feedback, ya!
 
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Y

ymunwai

#12
Dear Siewkingbee,

Greetings, I read your post regarding which certification to go for: ISO13485, GDPMDS..etc.

For my opinion, since you are a distributor, you will only need GDPMDS.
As you might aware, the Medical Device Bill has been approved. In order to register your company's establishment, you will require GDPMDS.

Singapore has already started the mandatory for GDPMDS for Singapore medical device distribution.

I know a certification body, and offer such service for GDPMDS certification in Malaysia. if you need the contact I can provide you. They are well known for medical device MS ISO13485..etc as well with very experience consultants.

Thanks.
 
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