Veterinary Diagnostic Kits Regulations in South East Asia

sreenu927

Quite Involved in Discussions
#1
Hi All,

I know this question is entirely unrelated to this forum.
However, I believe someone working in regulatory affairs might have experience with veterinary diagnostic and food safety regulations.
With a ray of hope, I seek some information on the following:
1. Are there any veterinary diagnostic kits regulations in Malaysia, Indonesia, Thailand, Korea and Vietnam?

I understood that these products need import permit, but not getting proper information of registration requirements.

Even any information related to relevant Associations and Consultants is highly appreciated!

Regards,
Sreenu
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 

sreenu927

Quite Involved in Discussions
#4
Thanks Stijloor and Marc.

I am in the process of finding the information through our distributors and finding the contact number of appropriate Authorities. Once I get complete information, I'l share with our Covers.

Regards,
Sreenu
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
That will be appreciated. I'm sorry no one here could help. Not many veterinary folks visit here so I'm sure you understand the lack of replies, but anything you can add may help someone if the future.
 

sreenu927

Quite Involved in Discussions
#6
Hi all,

This may be useful for someone when in need of vet.dx regulations:
1. Singapore - Veterinary Diagnostic kits need regulation and is regulated by AVA [www.ava.gov.sg]
2. Malaysia - Vet. Dx products are considered as vet biologics and require registration that takes 9-12 months; submit technical dossier that includes product info, marketing info, validation summary, CGMP cert, Free Sales Cert, Cert of Origin; requires import permit;
3. Philippines - requires registration (one time) and import permit for every shipment
4. Vietnam - no registration require; but requires import permit that is valid for one year-need to provide the list of all products that importer would like to import into Vietnam; cost is US$1000 for import permit
5. Korea- requires registration; documents are similar to the human IVD instruments

Indonesia - Still trying to get information; preliminary information is registration required.

Regards,
Sreenu
 
Q

QM Becky

#7
The information you have listed is very helpful. Are you aware of any regulations for NON diagnostic devices? For example, temperature, BP, SpO2? I am having a heck of a time finding anything on them.
Thank you!
 
J

jon.loo

#8
Aren't those also considered diagnostic? I can't speak for the rest of the countries but for Singapore, such non-biologic devices do not require regulatory approval as long as they are specifically intended for animal or birds (otherwise H.S.A. approval is required if they can be intended for human).
 
Q

QM Becky

#9
Our devices (the ones I'm inquiring about) are not diagnostic as they are for spot check in a clinical setting.
Thank you for the information regarding Singapore.
 
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