Setting up a Medical Device Distributor in Malaysia

Murni Ahmad

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#12
Hi there,

Sorry for my late response, i am currently handling the annual audit of my company. I read your Qs but dont really have time to sit and reply.

I agreed with Ronan. In short, adopt GDPMD as the standard for QMS for non manufacturing company (maybe AR, importer or distributor).
Have all the procedures documented (SOP or WIP or flow charts etc..)
Have a Regulatory Compliance Manual (usually called Quality Manuals), references all relevant SOP in it, you may want to include establishment profile in.

Going back to review all documents for audit:read:


Have a good day!
Muni
 
A

Agravaine

#13
Thanks guys, and no problem Ahmad! I hope all is going well during your audit.

Under our company our Quality Manual is our top-level document which references everything, and then the QMS falls under the Quality Manual as a "Quality Procedure". SOPs then fall under the Quality Procedures which detail what is mentioned in those Quality Procedures, which is why I was a little confused.

In the cases mentioned above, it seems the QMS sits on top and the Quality Manual follow underneath the QMS (in my company's case, the Quality Manual would be the equivalent of a Quality Procedure, I believe?). In our case, we have 4-5 Quality Procedures which outline all of the company's processes.

Then, of course, the SOPs detail those broader procedures.

Best of luck on your review, Ahmad. :)

EDIT: Essentially would it not be feasible to almost duplicate the GDPMD and exclude (with justification) any exceptions that would otherwise not apply to the distributor, and then attach all necessary documents under it as SOPs (with a Quality Manual for Documentation, separately)?
 
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Murni Ahmad

Involved In Discussions
#14
Hi Good Afternoon, its lunch hour here... :)

I am receiving mixed response from you regarding QMS.

To me (dear moderator, correct me if im wrong)

QMS is the system
A system you use in the company. Its cover the whole company based on the standard given.
GDPMD is the standard
You adopt/take to implement the QMS (other standard maybe ISO 13585, ISO 9000 etc). Serve as the backbone/guidelines of the QMS standard you want to achieve.
Quality Manual, a book/manual/compilation of work/procedure documents
Summary of all working procedure in the company to achieve the standard you set. This procedure which can be the procedures, work instruction, flow chart etc....
Then comes the documented procedure
Which is again the procedures, work instruction, records flow chart etc on how you carry daily activities/operation based on the standard adopt.

QMS is the system you adopt and implement, the way action/operation in the company.
Quality manual is the documented QMS, you write down your QMS in your Quality Manual for others to see. Quality manual should describe your QMS.


Its like running a class lesson
How you as a teacher conduct the class for the lesson is the QMS, from the beginning till the end of lesson.
Your syllabus will be the quality manual
you and the students is the MR and workers
then textbook/diagram will be the procedure and exercise books is the records/database to maintain :tg:
 
A

Agravaine

#15
QMS is the system you adopt and implement, the way action/operation in the company.
Quality manual is the documented QMS, you write down your QMS in your Quality Manual for others to see. Quality manual should describe your QMS.


Its like running a class lesson
How you as a teacher conduct the class for the lesson is the QMS, from the beginning till the end of lesson.
Your syllabus will be the quality manual
you and the students is the MR and workers
then textbook/diagram will be the procedure and exercise books is the records/database to maintain :tg:
This makes sense to me! The QMS=GDPMD and the Quality Manual documents the QMS.

The GDPMD requires that, under the documentation requirement, the QMS is documented and that is the Quality Manual/Regulatory Compliance Manual... I think?

Sorry for all the confusion!

:blowup:

EDIT: It looks like, at least at our company, the Quality Manual documents all the requirements of the QMS while our "Quality Management System" document talks about "documentation and records that are generated by the quality system" as well as to "manage documents outside the quality system". I feel as, as per the GDPMD standard, these two documents at my company may be reversed.

That is, the Quality Manual here is equivalent to the GDPMD and the QMS is the "quality manual" required under the documentation section of the GDPMD...
 
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A

Agravaine

#16
Hey,

I also noticed in another thread it was mentioned by a moderator that distributors may sometimes be treated like a manufacturer even if they do not produce the device at that location.

Is this true for Malaysia as I don't recall reading anything of that nature.
 

Murni Ahmad

Involved In Discussions
#17
Hi there,

Sorry for this late reply.

For foreign manufacturer there are a few things to consider
1. To have a LAR. Local Authorized Rep to do register your product
2. To have an importer. To import your product
3. To have a distributor. To do distribution/placement in the market.

Optionally, LAR can function as distributor and importer. I assume your distributor will do the importation and distribution. I suggest either appoint your current distributor as you LAR or find another company as your LAR ; to register the product in MedC@st.
All three roles will still need establishment license.
 

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