Can country-specific regulatory timelines be shortened if the device has a CE mark?

D

dcs1608

#1
Hello,
I hope I am not posting in a wrong forum.
I am the RA incharge at a medical device manufacturing firm. We have two Class II A devices that are CE marked.
I am trying to register the products in various countries such as Malaysia,Turkey, Sri Lanka, Israel,Australia etc. But they seem to involve a lot of time in giving approval. Is there any way to shorten the approval timelines by declaring that the products are CE marked?

Let me know.
Thanks.
 
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C

CBAL08

#2
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

It usually should not be complicated in the markets you have mentioned if Your Devices are CE marked.
In Australia if you have the sponser thye should know exactly what to do. Same in Turkey and the rest of the countries. It is not Clear from where you are applying.
 
D

dcs1608

#3
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

My firm is in India.
 

pkost

Trusted Information Resource
#4
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

Turkey is in the EU and therefore requires a CE mark
 
C

CBAL08

#5
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

I am sure if you have CE mark you have authorized Representative in Europe. They can help you with Turkey. You need to learn about the Other countries. I have already to you about Australia. I do not know how you have applied in these countries. Good Luck!
 

somashekar

Staff member
Super Moderator
#7
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

Hello,
I hope I am not posting in a wrong forum.
I am the RA incharge at a medical device manufacturing firm. We have two Class II A devices that are CE marked.
I am trying to register the products in various countries such as Malaysia,Turkey, Sri Lanka, Israel,Australia etc. But they seem to involve a lot of time in giving approval. Is there any way to shorten the approval timelines by declaring that the products are CE marked?

Let me know.
Thanks.
The response time is usually governed by the country authorities resources and queue rather than your credentials. Your lack of credentials will prolong your time, into years at times... but there is nothing that you can posses which can make happen the approvals in a jiffy .....
 
A

Ariel W

#8
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

Hello,
I hope I am not posting in a wrong forum.
I am the RA incharge at a medical device manufacturing firm. We have two Class II A devices that are CE marked.
I am trying to register the products in various countries such as Malaysia,Turkey, Sri Lanka, Israel,Australia etc. But they seem to involve a lot of time in giving approval. Is there any way to shorten the approval timelines by declaring that the products are CE marked?

Let me know.
Thanks.
The countries you mentioned each have their own interpretation so a CE mark alone will not be sufficient for an approval. In Australia a CMDCAS ISO13485 would greatly speed up the process, in Israel an approval usually takes nearly six months though based on CE mark, in some AMEA countries HMs require a documentation pack. In most cases local distributors know best how to get things done and often manage to get approvals faster.
 
#9
Re: Can country-specific regulatory timelines be shortened if the device has a CE mar

The countries you mentioned each have their own interpretation so a CE mark alone will not be sufficient for an approval. In Australia a CMDCAS ISO13485 would greatly speed up the process, in Israel an approval usually takes nearly six months though based on CE mark, in some AMEA countries HMs require a documentation pack. In most cases local distributors know best how to get things done and often manage to get approvals faster.
This is incorrect information. CMDCAS is a QMS and applies to Health Canada. This does not speed up the process for Australian registration. Anyone who resides in Europe and has an MRA (Mutual Recognition Agreement) with the Australian authorities can benefit.

Israel is four months (not six) and this will depend on the quality of technical documentation submitted to the authorities.

Distributors do not know best; manufacturers and regulatory professionals know best! There is no getting approvals faster unless either corruption is involved or, you get things right first time. :agree1:
 
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