Setting up a Medical Device Distributor in Malaysia

[Agravaine]

Hey,

Okay so I'm a bit new around these parts but I've entered into the regulatory field several months back and have poked around The Cove to find several helpful topics in the past and would like to say that the community here is great.

I'm not sure where exactly to start so I'll cut to the chase.

I work at a small medical devices company headquartered in Canada but we are opening up an international office in Malaysia for the main purpose of distributing our goods in that region. I have been tasked with figuring out which documents are important and should be sent over to that branch so that they do not need to go through the trouble of formulating their own documents from scratch.

Some documents are a little more obvious than others (shipping, receipt of stock, etc) but ultimately I'm just wondering if anybody has any tips, tricks, advice or even any useful documents for me in this position?

At the moment my plan is merely to go through (right now) the GDPMD for Malaysia and then Laws of Malaysia Act 738 (Medical Device Authority Act of 2012) but other than sifting through all our documents one by one, that's all I have.

Edit: also thought I'd mention again that the distributor we plan on setting up is doing just that--distributing, not manufacturing, etc.

Thanks,
Ag

 

[Ronen E]

Hi,

If you fully follow Malaysia laws and regulations, you will know exactly what that distribution branch has to have on file (as well as the formal registration process they will need to go through). Most of the documentation you will probably already have available in Canada, and the rest will be site specific. That's the right and safe way to go.

Good luck,
Ronen.

 

[Murni Ahmad]

Hi,

Just a quick input in term of regulatory requirement for MD in Malaysia.

To place a medical device in Malaysia, the product must be registered with MDA (still in transitional period now, mandatory in June/July 2015).

To register the product an Authorized Representative (AR) or Local Authorized Representative (foreign company need to appoint a LAR) will need to apply for establishment license, for this license a requirement is to adopt GDPMD as the QMS of the company, and audited by CAB body and update this certificate on MedC@st system.

AR will handle registration, as well as to appoint importer and distributor (if its a separate companies). These importer and distributor will need to have establishment license too..

For registration, a few guidelines has been published by MDA on their website such as
1. Definition
2.Classification
3.Grouping
4. Common Submission Dossier Template
and noted that IVD MD registration is differ from general MD

You can refer to these guidelines and give an idea of what to furnish your AR/LAR for purpose of registration.

You may need to help your LAR to get GDPMD certification.
Go through GDPMD guidelines, prepare all the documentation may include SOP, WIP for distribution records, post market activities etc..

 

[Agravaine]

Thank you both very much!

Right now I'm going through GDPMD that I found on another thread and I am trying to customize our quality/standard operating procedures for specific use by this distributor.

I've also gone through Act 737 and 738 briefly but was told to focus on the GDPMD document.

Essentially what I am trying to do is to excise all the unnecessary bits of detail from our procedures so our distributor does not need to go through things that might only confuse him or bog him down.

 

[Murni Ahmad]

Hi,


There is a good list here posted by Moups. summarized of important keys in GDPMD.

I`m a newbie too

 

[Agravaine]

Sorry for so many questions again, but I just want to clear up another thing that has just been brought to my attention:

All the requirements in the GDPMD guideline, must they all be met under one document or can they be fulfilled across several documents?

For example, we have a QMS document (one of our quality procedures) that covers most of the requirements and then other quality procedures that cover other aspects (management responsibility and review, etc.)

I've downloaded the GDPMD file you linked above, Murni, but I've noticed that certain requirements are only talked about in detail under our SOPs and this is why I am wondering.

Thanks!

 

[Murni Ahmad]

Well, im not sure if i am qualified to response to this.
But these are my thoughts through my experiences taking baby steps, getting GDPMD established, implemented and certified in my company within one year

1. Make sure you have each documented procedures in place.
2. Train the Quality personnel on how the flow of procedures and the connection would be. Referenced your Sops to your Quality Manual or so called Regulatory Compliance Manual to - i believed this is the answer you are looking for?
3. Explain these during CAB audit so they understand how you implement the procedures accordingly.
4. Don't forget to train the other staff too


(Did i mentioned im a regulatory and not quality based background )

Murni

 

[Agravaine]

Thank you very much for all the help so far, Ahmad.

I appreciate this help deeply!

EDIT: Oh, another thing I remember reading is that your GDPMD is essentially your quality manual, or is this not true and the distributor will require his own quality manual (along with procedures for his quality management system, etc.)?

Thank you!

 

[Ronen E]

Thank you very much for all the help so far, Ahmad.

I appreciate this help deeply!

EDIT: Oh, another thing I remember reading is that your GDPMD is essentially your quality manual, or is this not true and the distributor will require his own quality manual (along with procedures for his quality management system, etc.)?

Thank you!

GDPMD is the QMS for distributors.

 

[Agravaine]

I adopted a checklist of items to include in the Quality Manual/Regulatory Compliance Manual that I believe was provided by another member (it might have actually been Ahmad above) and I've attached it below. It's pretty much what I am going off of right now in terms of what to include in our Quality Manual for our Malaysian distributor.

I was under the impression, given everything written, that the Quality Manual is equivalent to the GDPMD and that both require a QMS (which is why I thought a Quality Manual was separate from simply requiring just a QMS for our distributor).

Sorry if this was not entirely clear!

EDIT: So, after taking another thorough look... The GDPMD is the QMS, and the QMS for Malaysian distributors requires that you include a Quality Manual (under documentation), also called a "regulatory compliance manual"?