GDPMD MALAYSIA Consultant and what they teach

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sammy_sm

My friend's company is searching for a consultant to implement GDPMD, and this is something new to us.
I usual handle ISO9001. I need to check with you guys for GDPMD process.

If we engage an external consultant to established the GDPMD certification project, what are the common training topics they will provide?

What are the topic of the training? How many days for the training? E.g 1/2/3 days of training?
1 day on awareness, 1 day on documentation, 1 day on legal and registration requirements?
 
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sammy_sm

thx slivehawk, I did go throw website , but I still got question for GDPMD .

Is the GDPMD cert assigned on company or products ? If assigned to company , meaning that we only need to apply once for all existing n future products. If assigned to products, is that mean we need to apply for all products including existing and future products ?
 
Y

ymunwai

Hi Sammy,
The GDPMD is assigned to company - it is a certification for company registration and the certificate can be provided by approved CABs. You only need to apply once for the the establishment licensing,but the GDPMD audits will be a yearly one.

For product registration ,it can be done online as well. Some product would required a CAB for review prior to registration. Hope this helps.
 
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sammy_sm

ymunwai ,

thank for your information . BTW, is the massage appliances need to obtain GDPMD ? is massage appliance under medical devices ? Any guide guideline ? I had try to check with CAB's but CAB said need to refer to principal .
please help
...
 

sreenu927

Quite Involved in Discussions
Hi Sammy,

Usually, massage chairs and their appliance are NOT considered as Medical Devices.

But again, if you have a specific intended use, then you may need to check the GHTF (IMDRF) Guidance on Classification of Medical Devices to verify it as a medical device or not and it's classification.

Regards,
Sreenu
 

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Y

ymunwai

Hi Sammy,

I also have the same idea that massage chair is not a medical device. The classification of a medical device is defined by the intended use.
 
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sammy_sm

Ymunwai ,

If massage chair with heat treatment function and CE marking .I believe it need to obtain GDPMD, refer to GHTF document Rule 9(i). All active therapeutic devices intended to administer or exchange energy are in Class B.

I had checked with CAB , they give me nonsense answer and me suffering now .
 

Ronen E

Problem Solver
Moderator
Ymunwai ,

If massage chair with heat treatment function and CE marking .I believe it need to obtain GDPMD, refer to GHTF document Rule 9(i). All active therapeutic devices intended to administer or exchange energy are in Class B.

I had checked with CAB , they give me nonsense answer and me suffering now .

A CE mark on its own means very little. A product can be CE marked under various directives, not necessarily the MDD. The real question is "Is it therapeutic?" The answer depends on the intended use as prescribed, or as concluded from the sum of the labelling.

Cheers,
Ronen.
 
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