Thai FDA warns against buying S Korean COVID-19 home test kits online

[snoop1130]

 

The Thai Food and Drug Administration (TFDA) is warning people against ordering South Korean-made COVID-19 home test kits, being offered by an online trader, saying that it has not yet been approved by the administration.

 

The trader claims, on its Facebook website, that its COVID-19 home test kits have been approved in South Korea and by the World Health Organization and the kits can show results in only 15 minutes.

 

The TFDA said today (Tuesday) that its officials have conducted an investigation and found that the trader’s claims are false and that the product has not been registered with the TFDA.

 

Full Story: https://www.thaipbsworld.com/thai-fda-warns-against-buying-s-korean-covid-19-home-test-kits-online/

 

-- © Copyright Thai PBS 2021-07-20

 

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[ukrules]

Why are they doing everything they can to stop people running their own tests?

 

Nobody cares what the Thai FDA thinks

[Walkabout]

They need time to figure out how to get their cuts . . .

 

[rbkk]

This is very confusing. It looks like the product is authorized, but not the online distributer. Here from BP...

They are

• Standard Q COVID-19 Ag Home Test produced by SD Biosensor Inc of Korea and imported by MP Group (Thailand);
• SARS-CoV-2 Antigen Self Test Nasal produced by SD Biosensor Inc of Korea and imported by Roche Diagnostics (Thailand);
• SARS-CoV-2 Antigen Test Kit (GICA) produced by Shenzhen Kisshealth Biotechnology and imported by General Science Enterprise; and
• SARS-CoV-2 Antigen Rapid Test Kit (Golloidal Gold Immunochromatography) produced by Beijing Lepu Medical Technology and imported by Ostland Capital.

• https://www.bangkokpost.com/business/2149991/covid-home-testing-kits-approved

• https://www.fda.moph.go.th/sites/Medical/Shared Documents/ข้อมูลรายชื่อชุดตรวจและน้ำยาสำหรับ COVID-19 ด้วตนเอง.pdf

[ArcticFox]

Protectionism at it's finest.  Only buy from our approved suppliers. 
"Humm, wonder why they are "approved?" 

[impulse]

1 hour ago, rbkk said:

This is very confusing. It looks like the product is authorized, but not the online distributer. Here from BP...

It's confusing, but very normal.  Products made for one country's market often don't meet the regulations in a different market.  The product itself may be different, or it may just be the packaging, instructions or safety advisories.  The Thai importer/distributor of the Korean test kit is responsible for making sure the kits meet Thai standards.  They're generally the ones who paid to have the testing done for gov't approval.  A different distributor hasn't gone down that path, and there's no way of knowing if the product they're importing is the same.

 

A great example is cars.  A Toyota Corolla built for the Korean market may not pass the safety or emission standards to sell into Europe.  It's still a Corolla.  But it's not the same car.

 

And from a business standpoint, it makes no sense for one distributor/importer to pay for the formalities if that's just going to allow anyone to import the product on their coat tails.  So country exclusivity is usually written into their contract with the manufacturer.  And that gives them the right to the trademark in that country.  (That's why you can't buy containers full of perfectly legal Nike clothes from China and import them to sell into the USA.  Nike owns that trademark in the USA)

 

[OJAS]

6 hours ago, snoop1130 said:

The Thai Food and Drug Administration (TFDA) is warning people against ordering South Korean-made COVID-19 home test kits, being offered by an online trader, saying that it has not yet been approved by the administration.

And no doubt the government, consistent with its track record to date of gross bungling incompetence and ineptitude in its handling of the pandemic, will drag its feet for months, if not years, before issuing the necessary approval.

[impulse]

10 minutes ago, ArcticFox said:

Protectionism at it's finest.  Only buy from our approved suppliers. 
"Humm, wonder why they are "approved?" 

In this rare case, Thailand is doing the right thing, protecting IP rights.  Only one source has the right to that trademark in Thailand.  That's the approved supplier.

 

And that's in addition to protecting the public from potential fakes.  Anyone with a few hundred $$$ of equipment can pump out fake test kits that cost 20 baht all in and sell for 200-300 baht.

 

[OJAS]

3 hours ago, Walkabout said:

They need time to figure out how to get their cuts . . .

 

They actually need more time to come up up yet more pointless measures to curb the spread of COVID-19, over and above completely useless alcohol bans and mandatory subscription to rip-off 100k USD insurance policies.

[tomazbodner]

2 hours ago, rbkk said:

This is very confusing. It looks like the product is authorized, but not the online distributer. Here from BP...

They are

• Standard Q COVID-19 Ag Home Test produced by SD Biosensor Inc of Korea and imported by MP Group (Thailand);
• SARS-CoV-2 Antigen Self Test Nasal produced by SD Biosensor Inc of Korea and imported by Roche Diagnostics (Thailand);
• SARS-CoV-2 Antigen Test Kit (GICA) produced by Shenzhen Kisshealth Biotechnology and imported by General Science Enterprise; and
• SARS-CoV-2 Antigen Rapid Test Kit (Golloidal Gold Immunochromatography) produced by Beijing Lepu Medical Technology and imported by Ostland Capital.

• https://www.bangkokpost.com/business/2149991/covid-home-testing-kits-approved

• https://www.fda.moph.go.th/sites/Medical/Shared Documents/ข้อมูลรายชื่อชุดตรวจและน้ำยาสำหรับ COVID-19 ด้วตนเอง.pdf

Was just going to say the same. I got this same one and it is the FIRST one listed on their approved test kits list. This list was published by several Thai news sites a few days back, quoting none other than Thai FDA.

 

Here's the mentioned kit's FDA approval from their own documents, updated today:

 

 

[smedly]

11 hours ago, snoop1130 said:

saying that it has not yet been approved by the administration.

its been approved in S Korea - what are you waiting on

 

get on with it

[impulse]

1 hour ago, smedly said:

its been approved in S Korea - what are you waiting on

 

get on with it

You don't figure it's wise to make sure the enclosed instructions in Thai are accurate and safe?

 

Read my post above.  The one with too many words.

 

 

[ikke1959]

The Thai GPO has declared that test kits are only available in a pharmacy because the people has to be told how to use them.. But it is only because the sellers here in Thailand want to make money out of it. And their business has to be protected..Scam again of Thai FDA

Quote

Quote

 

 

 

[impulse]

1 hour ago, ikke1959 said:

The Thai GPO has declared that test kits are only available in a pharmacy because the people has to be told how to use them.. But it is only because the sellers here in Thailand want to make money out of it. And their business has to be protected..Scam again of Thai FDA

Would you trust the ones sold on the street next to the genuine, guaranteed to be real Viagra?

 

[rabas]

 

Probably because it has been scientifically tested and reported to work?

 

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248921

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665091/

 

"The rapid SARS-CoV-2 antigen detection test, Standard™ Q COVID-19 Ag kit (SD Biosensor®, Republic of Korea), was compared with the real-time RT-PCR test"

 

"The rapid assay for SARS-CoV-2 antigen detection showed comparable sensitivity and specificity with the real-time RT-PCR assay. Thus, there is a potential use of this rapid and simple SARS-CoV-2 antigen detection test as a screening assay."

 

The WHO even has specific instructions on how to use this model sensor.