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

S

siewkingbee

#1
We are the distributor for products used in medical laboratories which include clinical chemistry, hematology, naemostasis, infectious disease, virology, histopathology, diagnosis and rapid test.
Do we need to be certified to ISO 13485?

We do not bear our company name on the product.
We only sell and service our customers.

thanks
 
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harry

Super Moderator
#2
........... Do we need to be certified to ISO 13485? .............
Usually determined by:

1. Is there a legal or regulatory need? Does not appear like it because you are just a local distributor.

2. Market or customer requirement - are there such requirements?

3. Organization need - does your company want to pursue it for some reasons?

If not, then it appears like there isn't a need. By the way, why do you ask?
 
S

siewkingbee

#3
How about the Good Distribution Practice GDPMDS? how do we know we should be GDPMDS compliant or ISO 13485..
or when we get ISO 13485 means we are GDP compliant?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
How about the Good Distribution Practice GDPMDS? how do we know we should be GDPMDS compliant or ISO 13485..
or when we get ISO 13485 means we are GDP compliant?
It actually depends on which territory you sell in, though I dare to say in most cases if you are ISO 13485 compliant you'd be GDP compliant as well.
 

Ajit Basrur

Staff member
Admin
#5
How about the Good Distribution Practice GDPMDS? how do we know we should be GDPMDS compliant or ISO 13485..
or when we get ISO 13485 means we are GDP compliant?
Refer to the GDPMDS (Singapore) in my post HERE

This document is applicable for import and distribution of medical devices in Singapore.

Can I know if you are based in Singapore ?

Btw, the organization certified to GDPMDS can be found here - http://www.isoguide.com/catid-87-di...evices+GDPMDS-mid-953-Classifications_MG.aspx
 
S

siewkingbee

#6
actually our products are mainly diagnostics kit and equipment, is ISO 13485 applicable to us? or GDPMDS? We are based in malaysia...so which do you think is more relevant for our industry, anyone in this industry certified? My customer is insisting for us to get one
 

Ronen E

Problem Solver
Staff member
Moderator
#7
actually our products are mainly diagnostics kit and equipment, is ISO 13485 applicable to us? or GDPMDS? We are based in malaysia...so which do you think is more relevant for our industry, anyone in this industry certified? My customer is insisting for us to get one
Hi,

Once again, the starting point is the territory you sell your products into, e.g. Malaysia, Singapore, Australia, China, other...? This will determine the regulatory system(s) and rules you would be subject to, including a definition of what would or would not be considered a medical device (i.e. are the products you're selling considered medical devices or not, in the relevant territories).

Some more / other requirements may apply to your operations under the Malaysian legislation (regardless of where you sell the products) simply because you are located there.

Anyway, if your customer insists on you getting a certain certification (be it 13485, GDPMDS or else), and you are unable to persuade them to waive that requirement, then regardless of regulatory requirements you would have to choose between getting certified or losing this customer...

Cheers,
Ronen.
 

Ajit Basrur

Staff member
Admin
#8
actually our products are mainly diagnostics kit and equipment, is ISO 13485 applicable to us? or GDPMDS? We are based in malaysia...so which do you think is more relevant for our industry, anyone in this industry certified? My customer is insisting for us to get one
Agree with Ronen and given the choice, my :2cents: is to go for GDPMDS as it directly relates to Distribution and less of Manufacturing !
 
S

siewkingbee

#9
Thanks Ronen & Ajit,

I had reviewed the standard in precise.
my situation - we are the distributor for the test kit is malaysia

1) yes, my diagnostic test kit is classified as a medical device as in the definition for medical device - any in vitro reagent intended by the manufacturer to be used for the purpose of - providing information of specimens derived from human body
2) In Malaysia, there is no one to certify for GDPMDS as yet
3) No choice but have to be certified to ISO 13485, right? in ISO 13485 never specify any scope... applicable for all org. that needs to demonstrate its ability to provide medical device that consistently meet customer and regulatory requirements.

In summary ISO 13485 applicable for manufacturers, distributors, traders (all related in the supply chain)

GDPMDS is not applicable to manufacturers.

Do enlighten me if my statement any of the above is not correct. THANKS

3)
 

Ajit Basrur

Staff member
Admin
#10
Thanks Ronen & Ajit,

I had reviewed the standard in precise.
my situation - we are the distributor for the test kit is malaysia

1) yes, my diagnostic test kit is classified as a medical device as in the definition for medical device - any in vitro reagent intended by the manufacturer to be used for the purpose of - providing information of specimens derived from human body
2) In Malaysia, there is no one to certify for GDPMDS as yet
3) No choice but have to be certified to ISO 13485, right? in ISO 13485 never specify any scope... applicable for all org. that needs to demonstrate its ability to provide medical device that consistently meet customer and regulatory requirements.

In summary ISO 13485 applicable for manufacturers, distributors, traders (all related in the supply chain)

GDPMDS is not applicable to manufacturers.

Do enlighten me if my statement any of the above is not correct. THANKS

3)
ISO 13485 applies for all manufactureres of medical devices and not for distributors and traders while GDPMDS is applicable for distributors.
 
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