Question on Authorized Representative (Malaysia)

C

clementn

Hi all,

I have an issue concerning the new registration of medical devices in Malaysia:


What happen if a company which sold some medical devices in Malaysia through a local authorized representative before the regulatory change does not want to sell anymore in this country ?

I mean, does this company must still register its products ?? (because the contract with the Authorized Representative is still valid and because we sold some devices in this country before)


Thank you very much in advance.

Clement
 

Ajit Basrur

Leader
Admin
Hi all,

I have an issue concerning the new registration of medical devices in Malaysia:


What happen if a company which sold some medical devices in Malaysia through a local authorized representative before the regulatory change does not want to sell anymore in this country ?

I mean, does this company must still register its products ?? (because the contract with the Authorized Representative is still valid and because we sold some devices in this country before)


Thank you very much in advance.

Clement

You can not sell devices in any country before obtaining regulatory approvals - these approvals are supreme and is Law !
 

somashekar

Leader
Admin
Hi all,

I have an issue concerning the new registration of medical devices in Malaysia:


What happen if a company which sold some medical devices in Malaysia through a local authorized representative before the regulatory change does not want to sell anymore in this country ?

I mean, does this company must still register its products ?? (because the contract with the Authorized Representative is still valid and because we sold some devices in this country before)


Thank you very much in advance.

Clement
Find an other representative.
After all to register your products, you need to do it through an authorized representative only.
 
C

clementn

Yes I know that, but in the Malaysian Act 737 it is write in the part "Saving and transitional" that :

(1) A person who, prior to the appointed date, has imported, exported or placed in the market medical devices shall, within twenty four months from the appointed date, apply for the registration of the medical devices under section 6.

So, my question is:

If we have sold some medical device in the past in Malaysia, and that the contract with our Authorized Representative is still valid, are we obligated to re-register our products in Malaysia regarding to the Malaysian law ?

Thanks
 

sreenu927

Quite Involved in Discussions
Hi Clement,

If your business is clear not to sell the products in MY, then you no need to register the product, although you had sold in the past.

Once the regulations are made mandatory and if you want to sell, then you can't sell without registration. So you must register and then sell.

But, if you foresee no business in Malaysia, why don;t you immediately cancel the Authorised Rep agreement (and, again-following your contractual terms).

Regards,
Sreenu
 
W

wc.nick

Hi all,

I have an issue concerning the new registration of medical devices in Malaysia:


What happen if a company which sold some medical devices in Malaysia through a local authorized representative before the regulatory change does not want to sell anymore in this country ?

I mean, does this company must still register its products ?? (because the contract with the Authorized Representative is still valid and because we sold some devices in this country before)


Thank you very much in advance.

Clement

Hi Clement,

I represent BSI Group, one of the five Conformity Assessment Body (CAB) appointed by the Medical Device Authority to conduct medical device assessment for the local market.

The short and quick answer to your question is that, if the local authorized representative (LAR) intends to being a LAR, then the person absolutely needs to get an 'establishment license for goods distribution' and register their products.

However, the liability doesn't intend to continue selling the products or any other medical devices product, then there's no need to register nor get an establishment license. (eg. if a med-tech company has solely gone on to sell pharmaceutical products.). The only thing is to make sure that there is documentation to back up the intention to discontinue medical device trading in Malaysia.

In either case, all companies are given till June 2014 to get an "establishment license" and until June 2015 to register their products.

I would love to speak more to you, if you'd write us an email. I can then assign you to our team to explore further on how we could help you or your LAR.

My email is nicklaus.au[at]bsigroup.com and my office tel is +603 7960 7801.

Nicklaus Au
Business Development, BSI Group
www[dot]bsigroup[dot]com[dot]my
 

tibon74

Involved In Discussions
Hi Wc.Nick

You said "In either case, all companies are given till June 2014 to get an "establishment license"" including the foreign manufacturers ?

thank you
 

Murni Ahmad

Involved In Discussions
Hi All,

Only local company will need to get an establishment license, which are

The local manufacturer
The AR or LAR (for foreign manufacturer)
The Importer
The Distributor

In short, if you conduct activities stated in GDPMD guidelines or GMP (for local manufacturer), you will need to go for conformity assessment and get GDPMD or GMP certified.
 

tibon74

Involved In Discussions
Hello!

What is the difference between "establishment license" and GDPMD certificate ? is it the same think ?
GDPMD certificate is provided by the CAB and establishment license by the health ministry. Exact?
Do we need the GDPMD certificate to have the establishment license?

thank you !
 

sreenu927

Quite Involved in Discussions
Hi tibon74,

According to Malaysian Regulations (Act 737),
"establishment" means -
a) a person who is either a manufacturer, importer or distributor who is responsible for placing any medical device in the market but does not include a retailer and
b) an authorised representative appointed by a manufacturer having a principal place of business outside Malaysia,
and such person and authorised representative being
A) a person domiciled or resident in Malaysia; or
B) a firm or company constituted under the laws of Malaysia, and carrying on business or practice principally in Malaysia.

Establishment must possess valid license to carry out activities related to medical devices in Malaysia.

Whereas, GDPMD Certificate is the certificate issued by the Conformity Assessment Bodies (CAB) which is one of the requirements to obtain Establishment License for Importer, Distributor and Authorized Representative.
For Manufacturers (of Medical devices), ISO 13485 certificate is required and no GDPMDS is required.

Regards,
Sreenu
 
Top Bottom